Compendial Test Methods

This page is presented as a service to the community. Feel free to email me with additional references as you see fit. I will post them when I can.

Sections: Microbial Limits Test | Antimicrobial Efficacy Test | Sterility Test | Bacterial Endotoxin Test

Microbial Limits Test

  • Cooper, Murray. 2003. Non-Sterile Druges, Cosmetics, Foods and Nutritionals. Microbiological Update. 21 .
  • Pharm Eur. 2003. 2.6.13 Microbial Examination of Non-Sterile Products (Test for Specified Micro-Organisms). Pharm Eur. 4.6:3877-3882.
  • USP. 2003. <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms Harmonization. Pharm Forum. pp. 1722-1735.
  • USP. 2003. <61> Microbial Limits Tests. Pharm Forum. 29:1714-1722.
  • USP. 2003. <1111> Microbiological Quality of Nonsterile Pharmaceutical Products Harmonization. Pharm Forum. 29:1733-1735.
  • Cooper, Murray. 2002. Non-Sterile Drugs, Cosmetics , Foods, Nutritionals and Botanicals. Microbiological Update. 20 .
  • Cundell, Anthony. 2002. Comparison of Microbio Testing Practices In Clinical, Food, Water and Pharmaceutical Microbio In Relation to the Microbio Attributes of Nutritional and Dietary Supplements. Pharm Forum. 28:964-985.
  • Martinez, JE. 2002. Microbial Bioburden On Oral Solid Dosage Forms. Pharm Technol. Feb:58-70.
  • Pharm Eur. 2002. 2.6.12 Total Aerobic Count. Pharm Eur. 4:133-136.
  • USP. 2002. <1111> Microbial Contamination Limits for Non-Sterile Products Harmonization Proposal. Pharm Forum. 28:916-919.
  • EP. 2001. Microbial Contam Limits for Non-Sterile Products. Pharmeuropa. 13:781-782.
  • Brescia, Beth Ann. 2001. Microbiological Examination of Nonsterile Products-Harmonization Review. Amer Pharm Review. 4:42-45.
  • Casey, Warren, et al. 2001. An Alternative Methodology for the General Test Chapter Microbial Limit Tests <61>. Pharm Forum. 27:2046-2050.
  • Cooper, Murray. 2001. Non-Sterile Drugs, Cosmetics, Botanicals and Dietary Supplements. Microbiological Update. 19 .
  • Manu-Tawiah, W et al. 2001. Setting Threshold Limits for the Significance of Objectionable Microorganisms In Oral Pharmaceutical Products. PDA J Pharm Sci Tech. 55:171-175.
  • Pharm. Eur. 2001. Microbial Contamination Limits for Non-Sterile Products. Pharmeuropa. 13:1.
  • USP. 2001. <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests Harmonization Proposal. Pharm Forum. 27:2299-2312.
  • USP. 2001. <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms Harmonization Proposal. Pharm Forum. 27:2313-2325.
  • EP. 2000. Microbio Exam of Non-Sterile Products (Test for Specified Micro-Organisms). Pharm Eur. Supp 2000:56-60.
  • Cooper, Murray. 2000. Non-Sterile Drugs, Food, Dietary Suppl, and Botanicals. Microbiological Update. 18 .
  • JP. 2000. Microbial Attributes of Non-Sterile Pharmaceutical Products Harmonization Document. JP.
  • Pharm Eur. 2000. Microbial Limits Harmonization Document. Pharm Eur.
  • Cooper, Murray. 1999. Non-Sterile Products. Microbiological Update. 16 .
  • Cooper, Murray. 1999. Microbial Limits for Non-Sterile Products. Microbiological Update. 17 .
  • Harber, K. 1999. Microbiological Examination of Nonsterile Products – Harmonization Proposal. Pharm Eur.
  • Pharm Eur. 1999. Comments On Stage 3 Microbial Limits Harmonization Document. Pharm Eur.
  • Richter, Steven. 1999. Product Contamination Control, a Practical Approach Bioburden Testing. J Validation Technology. 5:333-336.
  • USP. 1999. Comments On Stage 3 Microbial Limits Harmonization Document. USP.
  • USP. 1999. <1111> Microbiological Attributes of Nonsterile Pharmaceutical Products. Pharm Forum. 25:7785-7791.
  • USP. 1999. <61>Microbial Enumeration Tests. Pharm Forum. 25:7761-1774.
  • USP. 1999. <62>Microbio Procedures for Absence of Objectionable Microorganisms. Pharm Forum. 25:7774-7784.
  • Casey, W. et al. 1998. Use of Nonselective Preenrichment Media for the Recovery of Enteric Bacteria From Pharmaceutical Products. Pharm Technol. 22:114-117.
  • Cooper, Murray. 1998. Non-Sterile Products. Microbiological Update. 16 .
  • Tang, Shelley. 1998. Microbial Limits Reviewed: the Basis for Unique Australian Regulatory Requirements for Microbial Quality of Non-Sterile Pharmaceuticals. PDA J Pharm Sci Tech. 52:100-109.
  • Cooper, Murray. 1997. Non-Sterile Products. Microbiological Update. 14 .
  • Cooper, Murray. 1997. Non-Sterile Products. Microbiological Update. 15 .
  • JP. 1997. Decision of Limit for Bacterial Endotoxins. JP XIII. Suppl 1:1141-1142.
  • Cooper, Murray. 1996. Non-Sterile Drugs, Cosmetics and Foods. Microbiological Update. 14 .
  • Haberer, Klaus. 1996. Test for Microbial Contamination. Personal Communication. pp. 1-13.
  • JP. 1996. 30. Microbial Limit Test. JP XIII. pp. 49-55.
  • Orth, D.S. 1996. Microbiological Risk Assessment of Raw Materials. Cosmet Toilet. 111:43-45.
  • USP. 1996. <1111> Microbiological Attributes of Pharmaceutical Products. Pharm Forum. 22:3098-3102.
  • Cooper, Murray. 1995. Non Sterile Products. Microbiological Update. 12 .
  • Cooper, Murray. 1995. Non Sterile Products. Microbiological Update. 13 .
  • de la Rosa, MC, et al. 1995. Microbiological Quality of Pharmaceutical Raw Materials. Pharmaceutica Acta Helvetiae. pp. 227-232.
  • Ohara, Mitsuko. 1995. Application of Triphenyltetrazolium Chl In Microbial Limit Test of Pharmaceuticals and Cosmetics. J AOAC Intl. 78:1525-1529.
  • Cooper, Murray. 1994. Non Sterile Products. Microbiological Update. 12 .
  • JP. 1994. Microbial Limit Tests – Draft of New Text. JP Pharm Forum. 3:23-50.
  • Opalchenova, Ginka. 1994. A Comparison of the Microbial Limit Tests In the British, European, and US Pharmacopeias and Recommendations for Harmonization. Pharm Forum. 20:7872-7877.
  • TGA. 1994. Therapeutic Goods Administration Laboratories’ Guidelines for Assessing the Results of Microbiological Tests On Non-Sterile Pharmaceuticals for Human Use. TGA. pp. 1-2.
  • TGA. 1994. TGAl Guidelines for Assessing the Results of Microbiological Tests On Non-Sterile Pharmaceuticals for Human Use. TGA. Reviewed 03/03 .
  • USP. 1994. <61>Microbial Limit Tests. USP 23. pp. 1681-1690.
  • Cooper, Murray. 1993. Non-Sterile Products. Microbiological Update. 11 .
  • Vivar, Carmen et al. 1993. Survival of Staphylococcus aureus In Oral Administration Liquid Medicaments and Influence of Count Medium On Survival. J Pharm Sci. 82:170-173.
  • Warwick, E.F. 1993. Role of Preserv In Controlling Microbial Contam Introduced In the Manufacture of Cosmetics. J Appl Cosmetol. 11:49-53.
  • Cooper, Murray. 1992. Non-Sterile Products. Microbiological Update. 9 .
  • Cooper, Murray. 1992. Non Sterile Products. Microbiological Update. 9 .
  • Cooper, Murray. 1992. Microbial Limit Testing of Non Sterile Products. Microbiological Update. 10 .
  • USP. 1992. A Proposal for Revisions to the USP General Information Chapter Microbiological Attributes of Nonsterile Pharmaceutical Products <1111> (Stimuli Article). Pharm Forum. 18:4093-4095.
  • USP. 1992. <1111> Microbiological Attributes of Pharmaceutical Products. Pharm Forum. 18:3596-3600.
  • Agalloco, J and Akers, JE. 1991. USP Proposal for Microbial Limits Specifications (Letters to the Editor). PDA J Parenteral Sci Tech. 45:168-169.
  • Tenenbaum, S. 1991. Microbiological Limit Guidelines for Cosmetics and Toiletries. CTFA Cosmet J. 4:25-31.
  • Bloomfield, S.F. 1990. Microbial Contamination: Spoilage and Hazard. Guide to Microbiological Control In Pharm.
  • Cooper, Murray. 1990. Microbial Limits and Non-Sterile Products. Microbiological Update. 8 .
  • Cooper, Murray. 1990. Microbial Limits and Non Sterile Products. Microbiological Update. 8 .
  • Lampe, C, et al. 1990. PDA Tech Report #21: Bioburden Recovery Validation. PDA J Parenteral Sci Tech. 44:324-331.
  • Bos, C.E. et al. 1989. Microbiological Stability of Tablets Stored Under Tropical Conditions. Int J Pharm. 55:175-182.
  • Cooper, Murray. 1989. Microbial Limit Testing of Non Sterile Products. Microbiological Update. 6 .
  • Cooper, Murray. 1989. Microbial Limit Testing. Microbiological Update. 7 .
  • USP. 1989. <1111> Microbiological Attributes of Nonsterile Pharmaceutical Products. USP XXII. pp. 1684-1685.
  • USP. 1989. <61> Microbial Limits Tests. USP XXII. pp. 1479-1483.
  • Avallone, Henry. 1988. Microbiological Control of Topicals. Pharm Technol. 12:55-62.
  • Cooper, Murray. 1988. Microbial Limit Topics. Microbiological Update. 6 .
  • Tsuji, Kiyoshi. 1988. An Expert System for Assessing the Microbiological Quality of Pharmaceutical Products and Materials. Pharm Technol. 12:154-158.
  • USP. 1988. <1111> Microbiological Attributes of Nonsterile Pharmaceutical Products. Pharm Forum. 14:3616.
  • Ashour, M.S.et al. 1987. Microbial Contamination of Cosmetics and Personal Care Items In Egypt. Cosmet Toilet . 102:61-68.
  • Cooper, Murray. 1987. Non-Sterile Products. Microbiological Update. 5 .
  • Ferguson, a et al. 1987. Comparison of Two Incubation Temperatures for the Isolation of Gram-Negative Contaminants From Raw Materials and Non-Sterile Pharmaceuticals. J Clin Pharm Therapeut. 12:249-254.
  • Cooper, Murray. 1986. Microbial Limits Topics. Microbiological Update. 3 .
  • Cooper, Murray. 1986. Microbio Limit Topics. Microbiological Update. 4 .
  • Cooper, Murray. 1986. Microbial Limits Topics. Microbiological Update. 4 .
  • Madis, V.H. 1986. The Sampling of Crude Botanicals. Drug Cosmet Ind. 138:40-43.
  • Plumpton, EJ et al. 1986. Effect of Spatial Distribution of Contaminant Microorganisms Within Tablet Formulations On Subsequent Inactivation Through Compaction. Int J Pharm. 30:237-240.
  • Baird, RM. 1985. Microbial Contamination of Non-Sterile Pharmaceutical Products Made In Hospitals In the North East Regional Health Authority. J Clin Hosp Pharm. 10:95-100.
  • Spooner, DF. 1985. Microbiological Criteria for Non-Sterile Pharmaceuticals. Manufact Chem. 56:41-45.
  • Spooner, DF. 1985. Microbiological Criteria for Non-Sterile Pharmaceuticals. Manufact Chem. 56:71-75.
  • USP. 1985. <61> Microbial Limits Tests. Us Pharmacopeia Nat’L Formulary Xvi. pp. 1150-1160.
  • Baggerman, C. et al. 1984. Microbiological Contamination of Raw Materials for Large-Volume Parenterals. Appl Environ Microbiol. 48:662-664.
  • Baird, R.M. 1984. Bacteriological Contamination of Products Used for Skin Care In Babies. Int J Cosmet Sci. 6:85-90.
  • Price, Jeffrey. 1984. Establishing Microbiological Specifications for Pharmaceuticals Not Required to Be Sterile. Pharm Mfg. 1:26-29.
  • USP. 1984. <1111> Microbiological Attributes of Nonsterile Pharmaceutical Products. Pharm Forum. 10:4593-4594.
  • USP. 1984. <61> Microbial Limits Tests. USP XXI. pp. 1151-1156.
  • USP. 1984. <1111> Microbiological Attributes of Nonsterile Pharmaceutical Products. USP XXI. pp. 1329-1330.
  • Van Doorne, H and A. Lint. 1984. A Note On the Suitability of Dip Slides for the Microbiological Exam of Water and Aqueous Non Sterile Pharmaceutical Prep. Pharm Weekbl Sci Ed. 6:111-113.
  • Cooper, Murray. 1983. Microbio Attributes of Non-Sterile Pharmaceuticals. Microbiological Update. 1 .
  • USP. 1982. <1111> Microbiological Attributes of Nonsterile Pharmaceutical Products. Pharm Forum. 8:1736-1737.
  • USP. 1982. Microbial Contamination of Sterile and Non-Sterile Articles, with Special Reference to Pseudomas cepacia. Pharm Forum. 8:2239.
  • USP. 1982. <61> Microbial Limits Tests. Pharm Forum. 8:2217-2218.
  • Hooper, WL. 1981. Microbiological Testing of Non-Sterile Pharmaceuticals. J Appl Bacteriol. 51:vi-vII.
  • Malcolm, S.A. 1981. Microbiological Limits for Nonsterile Pharmaceuticals. J Appl Bacteriol. 51 .
  • Pavanetto, F et al. 1981. The Microbiological Quality of Some Talc-Based Dusting Powders. Cosmet Toilet . 96:59-61.
  • Somerville, PC. 1981. A Survey Into Microbial Contamination of Non-Sterile Pharmaceutical Products. Farm Tijdschr Belg. 58:345-350.
  • Bonalsky, Jan. 1980. A Model System for Testing Raw Materials for Microbological Content. Pharm Technol. 4:49-51.
  • USP. 1980. Microbial Limit Tests. Pharm Forum. 6:337.
  • USP. 1980. Microbial Limit Tests. USP XX. pp. 874.
  • USP. 1980. <1111> Microbiological Attributes of Nonsterile Pharmaceutical Products. USP XX. pp. 1019.
  • Wachi, Y.et al. 1980. Decomposition of Surface Active Agents by Bacteria Isolated From Deionized Water. J Soc Cosmet Chem. 31:67-84.
  • Goldman, C.L. 1979. Microorganisms Isolated From Cosmetics. Drug Cosmet Ind. 117:40-41.
  • Van Doorne, H, and EPM Claushuis. 1979. The Quantitative Determination of Enterobacteriaceae In Pharmaceutical Preparations. Int J Pharm. 4:119-125.
  • Hitokoto, H. et al. 1978. Fungal Contamination an Mycotoxin Detection of Powdered Herbal Drugs. Appl Environ Microbiol. 36:252-256.
  • Jayasekara, B. et al. 1978. Determination of Low Level Microbiological Contamination In Cosmetics by Thin Film Agar. Cosmet Toilet . 93:67-73.
  • USP. 1978. Microbial Testing of Oral Dosage Forms. Pharm Forum. 4:103.
  • USP. 1978. Microbial Testing of Oral Dosage Forms. Pharm Forum. 4:104-110.
  • Wallhausser, K.H. et al. 1978. Microbial Quality Control of Skin Care Preparations. Cosmet Toilet. 93:42-48.
  • Yablonski, J.I. 1978. Microbiological Aspects of Sanitary Cosmetic Manufacturing. Cosmet Toilet. 93:37-50.
  • Baird, RM. 1977. Microbial Contamination of Cosmetic Products. J Soc Cosmet Chem. 28:17-20.
  • Bonomi, E. Et al. 1977. Studies On the Microbial Content of Raw Materials Used In Pharmaceutical Preparations. Ann Ist Super Sanita. 13:805-832.
  • CTFA Subcommittee. 1977. CTFA National Microbiological Survey of Cosmetics and Toiletries 1972-1975. CTFA Cosmet J. 9:24-31.
  • EP. 1977. Use of Polyoxyethanol In Test for Bacteriological Contam of Ointments. Pharm Eur. May:3 pgs.
  • Hart, a and PE Kite. 1977. Comparison of Four Selective Agars for the Isolation of Pseudomonads. Appl Environ Microbiol. 33:1209-1214.
  • Tenenbaum, Saul. 1977. Considerations Leading to the Development of the Microbial Limit Guidelines of the CTFA. Cosmet Toilet. 92:79-83.
  • USP. 1977. Microbial Limit Tests. Pharm Forum. 3:411-416.
  • Wallhausser, K.H. 1977. Microbial Aspects On the Subject of Oral Solid Dosage Forms. Pharm Ind. 39:491-497.
  • Beerens, H et al. 1976. Techniques for the Enumeration of Microorganisms In Cosmetic Preparations. Soap Perf Cosmet. 48:262-263.
  • Kano, C. et al. 1976. Microbial Quality Control for the Manufacture of Cosmetic Emulsions. J Soc Cosmet Chem. 27:73-86.
  • Moore, KE and JE Taylor. 1976. Microbiological Standards for Nasal Solutions. J Appl Bacteriol. 41:379-387.
  • USP. 1975. Microbial Limit Tests. USP XIX. pp. 588.
  • USP. 1975. Microbiological Attributes of Non-sterile Pharmaceutical Products. USP XIX. pp. 695.
  • Ahearn, DG et al. 1974. Microbial Growth In Eye Cosmetics: Contamination During Use. Dev Ind Microbiol. 15:211-216.
  • Jarvis, B. et al. 1974. Survey of Microbiological Contamination In Cosmetics and Toiletries In the UK (1971). J Soc Cosmet Chem. 25:563-575.
  • Jasnow, S.B.et al. 1974. Microwave Sanitization of Color Additives Used In Cosmetics: Feasibility Study. Appl Microbiol. 30:205-211.
  • Jasnow, S.B.et al. 1974. Microwave Sanitization of Color Additives Used In Cosmetics: Feasibility Study Correction. Appl Microbiol. 30:205-211.
  • McConville, J.F.et al. 1974. Method for Performing Aerobic Plate Counts of Anhydrous Cosmetics Utilizing Tween 60 and Arlacel 80 As Dispersing Agents. Appl Microbiol. 27:5-7.
  • Allwood, M.C. and R. Hambleton. 1973. The Recovery of Bacteria From White Soft Paraffin. J Pharm Pharmacol. 25:559-562.
  • Chowchuvech, Enliam. 1973. Effect of Various Microorganisms Found In Cosmetics On the Normal and Injured Eye of the Rabbit. Amer J Ophthalmol. 75:1004-1009.
  • Myers, GE and FM Pasutto. 1973. Microbial Contamination of Cosmetics and Toiletries. Can J Pharm Sci. 8:19-23.
  • Scott, H. 1973. Methods for Counting and Testing for Microorganisms In Raw Materials Topical and Oral Products. J Soc Cosmet Chem. 24:65-78.
  • Waterman, Robert et al. 1973. Survival of Staphylococcus aureus On Pharmaceutical Oral Solid Dosage Forms. J Pharm Sci. 62:1317-1320.
  • Bruch, CW. 1972. Possible Modification of USP Microbial Limits and Tests. Drug Cosmet Ind. 110:32-37, 116-121.
  • Bruch, CW. 1972. Objectionable Microorganisms In Nonsterile Drugs and Cosmetics. Drug Cosmet Ind. 11:51.
  • Evans, J.R.et al. 1972. Methods for Isolating and Identifying Objectionable Gram Negative Bacteria and Endotoxins From Topical Products. J Soc Cosmet Chem. 23:549-564.
  • Marzulli, F.N.et al. 1972. Induced Pseudomonas Keratitis As Related to Cosmetics. J Soc Cosmet Chem. 23:89-97.
  • Miller, W.S.et al. 1972. Microbiological Controls In Packaging. Drug Cosmet Ind. 110:38.
  • Smart, R and DF Spooner. 1972. Microbiological Spoilage In Pharmaceuticals and Cosmetics. J Soc Cosmet Chem. 23:721-737.
  • Bowman, Frances et al. 1971. Microbial Contamination of Nonsterile Antibiotic Market Samples: a Survey. J Pharm Sci. 60:1099-1101.
  • Bruch, CW. 1971. Cosmetics: Sterility vs Microbial Control. Amer Perfum Cosmet. 86:45-50.
  • Bruch, CW. 1971. Microbiological Products of Topical Quality – Types vs Numbers of Microorganisms. Drug Cosmet Ind. July:26.
  • Curry, J.C, and EG Butera. 1971. A Laboratory Comparision of Selective for Media for Pseudomonas In Cosmetics and Toiletries. Dev Ind Microbiol. 12:165-172.
  • Sykes. G. 1971. The Control of Microbial Contamination In Pharmaceutical Products for Oral and Topical Use – Raw Materials. J Mond Pharm. 14:8-20.
  • Beveridge, E.G.,et al. 1970. Microbial Content of Pharmaceutical Solutions. Pharm J. 207:102-103.
  • Herman, LG. 1970. The Microbiology of the Intimate Environment. PDA Bulletin of Parenteral Drug Assoc. 24:105-109.
  • Parker, Malcon. 1970. The Microbial Control of Drugs and Cosmetics. Soc of Cosmetic Chemists of Great Britain. XLIV:47.
  • Tenenbaum, S. 1970. Microbial Content of Cosmetics and Nonsterile Drugs. Cosmetics & Perfumery. 88:49-53.
  • USP. 1970. Microbial Limit Tests. USP XVIII. pp. 846.
  • USP. 1970. Microbiological Attributes of Non-sterile Pharmaceutical Products. USP XVIII. pp. 800.
  • Beach, W.J. 1969. Production/Engineering: Microbial Content of Cosmetics and Toiletries. Soap Chem Spec. 45:142.
  • Dunnigan, A.P. and J.R. Evans. 1969. Proposed Methodology for the Isolation of Gram Negative Microorganisms From Ointments and Lotions. TGA J Cosmet. 38:38-41.
  • Fantasia, LD et al. 1969. Comparison of Two Procedures for Detection of Salmonella In Food, Feed, and Pharmaceutical Products. Appl Microbiol. 17:540-541.
  • Frank, C.L. 1969. Microbiological Contamination In Industry. Amer Perf Cosmet. 84:49-51.
  • Schiller, I.et al. 1968. Microbial Content of Nonsterile Therapeutic Agents Containing Natural or Seminatural Active Ingredients. Appl Microbiol. 16:1924-1928.
  • Ulrich, K. 1968. Microbial Content In Non-Sterile Pharmaceuticals. Dansk Tidsskr Farm. 42:1-4, 50-55, 71-83, 257-263.
  • White, M et al. 1968. Bacterial Contamination In Some Nonsterile Antibiotic Drugs. J Pharm Sci. 57:1061-1063.
  • White, M et al. 1968. Bacterial Contamination In Some Nonsterile Antibiotic Drugs. J Pharm Sci. 57:1061-1063.
  • Tenenbaum, S. 1967. Pseudomonads In Cosmetics. J Soc Cosmet Chem. 18:797-807.
  • USP. 1965. Gelatin – Bacteriological Tests. USP XVII. pp. 827.
  • Trexler, PC. 1964. Microbic Contamination Control. PDA Bulletin of Parenteral Drug Assoc. 18:8-12.
  • USP. 1960. Gelatin – Bacteriological Test. USP XVI. pp. 854.
  • USP. 1955. Gelatin – Bacteriological Test. USP XV. pp. 839-841.
  • USP. 1950. Gelatin-Bacteriological Test. USP XV. pp. 839.
  • USP. 1950. Bacteriological Examination of Gelatin. USP XIV. pp. 687-689.
  • USP. 1947. Bacteriological Examination of Gelatin. USP XIII. pp. 621-623.
  • USP. 1942. Bacteriological Examination of Gelatin. USP XII. pp. 556-559.

Antimicrobial Efficacy Test

  • Matthews, BR. 2003. Preservation and Preservative Efficacy Testing: European Perspectives. Eur J Parent Pharm Sci. 8:99-107.
  • Pharm Eur. 2002. Efficacy of Antimicrobial Preservatives. European Pharmacopoeia. 5:3.
  • Sutton, SVW and D Porter. 2002. Development of the Antimicrobial Effectiveness Test As USP Chapter <51>. PDA J Pharm Sci Tech. 56:300-311.
  • USP. 2002. <51> Antimicrobial Effectiveness Testing. USP 25. NF 20:1869-1871.
  • Yamada, Akira. 2002. Preservatives-Effectives Tests. JP Pharm Forum. 11:2002.
  • EMEA. 2001. In Use Stability Testing of Human Medicinal Products. EMEA. Mar:1/1-2/2.
  • EP. 2001. Chapter 5.1.3 Test for Efficacy of Antimicrobial Preservation. Pharmeuropa. 13:597-599.
  • Kanda Izumicho; Chiyoda-ku. 2001. Preservatives-Effectiveness Tests. Society of Japanese Pharmacopoeia. pp. 1321-1323.
  • Machtiger, Neal. 2001. Determination of the Efficacy of the Preservation of Non-Eye Area Water Miscible Cosmetic and Toiletry Formulations: Collaborative Study. J AOAC Intl. 84:101.
  • Orth, D.S. 2001. Preservative Efficacy Testing of Aqueous Cosmetics and Drugs Without Counting Colonies. Cosmet Toilet. 116:41-47.
  • USP. 2001. Proposed Revisions and New Text Previously Presented In PF But Now Canceled. Pharm Forum. 27:2034-.
  • Ciarciaglini, Gianni, et al. 2000. Germination Induced Bioluminescence, a Route to Determine the Inhibitory Effect of a Combination Preservation Treatment On Bacterial Spores. Appl Environ Microbiol. 66:3735-3742.
  • Favet, J., et al. 2000. Adaptation of the Ph. Eur. Test for Efficacy of Antimicrobial Preservation to Zinc Gelatin. Pharmeuropa. 12:376-383.
  • International Standard. 2000. ISO – 14730 : Ophthalmic Optics- Contact Lens Care Products – Antimicrobial Preservative Efficacy Testing and Guidance On Determining Discard Date. ISO. ISO 114730 : 2000 (E):1-23.
  • Muth, H et al. 2000. The Effects of Antimicrobial Preservatives On Organisms Derived From Fresh versus Frozen Cultures. Pharm Forum. 26:519-533.
  • USP. 2000. <51> Antimicrobial Effectiveness Testing. USP 24. NF 19:1808-.
  • CVMP. 1999. EMEA/CVMP/198/99 – Revision Consultation: Nfg: Maximum Shelf-Life for Sterile Medicinal Products After First Opening or Followng Reconstitution. EMEA. Apr .
  • EMEA. 1999. In-Use Stability Testing. EMEA. Dec:1/2-3/3.
  • Orth, D.S. 1999. Putting the Phoenix Phenomenon Into Perspective. Cosmet Toilet. 114:61-66.
  • TGA. 1999. Preservative Efficacy In Multidose Pharmaceutical Preparations. TGA Laboratories. May:11-12.
  • USP. 1999. <51> Antimicrobial Effectiveness Testing. Pharm Forum. 25:7513-7514.
  • EMEA. 1998. Max Shelf Life for Sterile Products for Human Use After First Opening or Following Reconstitution. EMEA. Jan:1/1.
  • Sutton, SVW et al. 1998. In-Use Stability Testing: What Data Are Required and When?. Reg Affairs J. pp. 728-733.
  • USP. 1998. <52>Antimicrobial Effectiveness Testing for Vaccines. Pharm Forum. 24:6269-6272.
  • van Doorne, H.; J. Colledge, et al. 1998. A Simple Method to Establish the Vulnerability of Hydrophobic Aqueous Dermatological Emulsions to Potential Microbial Contamination. Pharmeuropa. 10:480-483.
  • Dabbah, Roger; Knapp, Joseph. 1997. Harmonization of Microbiological Methods-A Status Report. Pharm Forum. 23:5334-5344.
  • USP. 1997. <51> Antimicrobial Preservatives – Effectiveness. Pharm Forum. 23:3806-3815.
  • USP. 1997. <51> Antimicrobial Effectiveness Testing. Pharm Forum. pp. 3807-3815.
  • Cooper, Murray. 1996. Preservatives and Preservative Testing. Microbiological Update. 14 .
  • EP. 1996. Efficacy of Antimicrobial Preservation: International Harmonization-Stage 5A Consensus. Pharmaeuropa, Barcelona. pp. 2-8.
  • Hodges, N.A.; Denyer, S.P.; Hanlon, G.W. 1996. Preservative Efficacy Tests In Formulated Nasal Products: Reproducibility and Factors Affecting Preservative Activity. J Pharm Pharmacol. 48:1237-1242.
  • JP. 1996. 3. Preservatives-Effectiveness Tests. JP XIII. pp. 1069-1071.
  • Pharm Eur. 1996. Efficacy of Antimicrobial Preservation – Harmonization Proposal. Pa/Ph/Exp 1Cm/T (93) 10 Anp2R.
  • Pharm Eur. 1996. Efficacy of Antimicrobial Preservation – Harmonization Proposal. Letter to USP.
  • Schalkowsky, Samuel. 1996. Predictive Antimicrobial Preservative Effectiveness Testing. Pharm Forum. 22:2690-2695.
  • USP. 1996. <51> Antimicrobial Preservatives – Effectiveness. Pharm Forum. 22:3212-3221.
  • Brannan, Daniel. 1995. Cosmetic Preservation. J Soc Cosmet Chem. 46:199-220.
  • Cooper, Murray. 1995. Antimicrobial Preservation. Microbiological Update. 12 .
  • Keeven, J et al. 1995. Evaluating the Preservative Effectiveness of RGP Lens Care Solutions. CLAO. 21:238-241.
  • USP. 1995. <51> Antimicrobial Preservatives – Effectiveness. Pharm Forum. 21:1040-1046.
  • Ashworth, David; Karen Turton. 1994. An Alternative to Removing Preservatives From Formulations. Drug Cosmet Ind. Sept:40-44.
  • Cooper, Murray. 1994. Antimicrobial Preservation. Microbiological Update. 12 .
  • Cooper, Murray. 1994. Some Issues Associated with International Harmonization of the Preservative Effectiveness Test. Pharm Forum. 20:8589-8592.
  • EP. 1994. Efficacy of Antimicrobial Preservation. Pharmeuropa. 6:387-388.
  • Farrington, J.K.; E.L. Martz. 1994. Ability of Lab Methods to Predict In-Use Efficacy Antimicrobial Preservatives In an Experimental Cosmetic. Appl Environ Microbiol. 60:4553-4558.
  • Tran, T.T. et al. 1994. Adequacy of Cosmetic Preservation: Chemical Analysis, Microbial Challenge and In Use Testing. Int J Cosmet Sci. 16:61-76.
  • USP. 1994. <51> Antimicrobial Preservatives – Effectiveness. USP 23. pp. 1681-1690.
  • Ayres, Helen. 1993. A Rapid Method of Evaluating Permeabilizing Activity Against Pseudomonas aeruginosa. Lett Appl Microbiol. 17:149-151.
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Sterility Test

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  • Tsuji K, Robertson JH. 1973. Microbial Toxicity of Isopropyl Myristate Used for Sterility Testing of Petrolatum-Based Ophthalmic Ointments. Appl Microbiol. 25:139-145.
  • Kantor, Nathan; Patricia Saunders, et al. 1972. Cellulase: Its Use In Sterility Testing. PDA Bulletin of Parenteral Drug Assoc. 26:41-51.
  • Stapert, EM. 1972. Designing and Monitoring a Sterility Test Facility. PDA Bulletin of Parenteral Drug Assoc. 26:129-138.
  • Bowman, Frances et al. 1971. Collaborative Study of Aerobic Media for Sterility Testing by Membrane Filtration. J Pharm Sci. 60:1087-1088.
  • Russell, EC et al. 1971. Cutter for Membrane Filters Used In Sterility Testing. Appl Microbiol. 21:1110-1111.
  • Schmitt, R. 1971. Environmental Microbial Load As Related to Sterilization and Sterility Testing. PDA Bulletin of Parenteral Drug Assoc. 25:31-39.
  • Tsuji K, Robertson JH. 1970. Microcount Method for Petrolatum-Based Topical Ointments Containing Waxes. Appl Microbiol. 20:802-804.
  • Tsuji K, Stapert EM, Robertson JH, Waiyaki PM. 1970. Sterility Test Method for Petrolatum-Based Ophthalmic Ointments. Appl Microbiol. 20:798-801.
  • Tsuji,K.,et al. 1970. Sterility Testing Method for Petrolatum Based Ophthalmic Ointments. pp. 798-801.
  • USP. 1970. Sterility Tests. USP XVIII. pp. 851.
  • Bowman, Frances. 1969. The Sterility Testing of Pharmaceuticals. J of Pharm Sciences. 58:1301-1308.
  • Ernst, RR et al. 1969. Problem Areas In Sterility Testing. PDA Bulletin of Parenteral Drug Assoc. 23:29-39.
  • Bowman, Fw, et al. 1968. Laminar Air Flow for Environmental Control and Sterility Testing. PDA Bulletin of Parenteral Drug Assoc. 22:57-65.
  • Farber, JF and EB Seligmann. 1968. Bacteroides Vulgatus, a Nonsporeforming Anaerobe for Testig Fluid Thioglycollate Medium. Appl Microbiol. 16:1102-1103.
  • Brewer, JH and RF Schmitt. 1967. Special Problems In the Sterility Testing of Disposable Medical Devices. PDA Bulletin of Parenteral Drug Assoc. 21:136-141.
  • Bowman,F.W. 1966. Application of Membrane Filtration to Antibiotic Quality Control Sterility Testing. J Pharm Sci. pp. 818-821.
  • Gay, M and B Fust. 1965. Appartur Zum Nachweis Von Mikroorganismsn Durch Membranfiltration Und Ihre Andwendung Zur Prufung Con Arznimitteln Auf Verunreinigende Mikroorganismen (Sterilitatsprufung). Zentr Bakteriol Parasitenk. 197:389-401.
  • USP. 1965. Sterility Tests. USP XVII. pp. 829.
  • Frediani, HA. 1964. Membrane Filtration Sterility Testing. PDA Bulletin of Parenteral Drug Assoc. 18:25-27.
  • Russomanno, R and EG Wollish. 1964. Method for Sterility Testing of Oils. J Pharm Sci. 53:1538-1539.
  • Mathews, AG. 1963. Sterility Testing of Biologicals, 1957-1962. Australasian J Pharm. 44:S62-S66.
  • Bowman, FW. 1962. Revised Procedures for Sterility Tests for Certifiable Antibiotics. PDA Bulletin of Parenteral Drug Assoc. pp. 15-23.
  • Lambin, MS et al. 1962. La Technique Des Membranes Filternates Appliquee a L’Essai De Sterilite Des Substances Antibiotiques. Ann Pharm Franc. 20:749-767.
  • Blumberg, H and I Brown. 1961. Size of Culture Tubes for Sterility Testing of Oleaginous Products. PDA Bulletin of Parenteral Drug Assoc. 15:28.
  • Gain, JF. 1961. Sterility Testing of Products Containing Benzalkonium Chloride As a Preservative. PDA Bulletin of Parenteral Drug Assoc. 15:8-18.
  • Holdowsky, S. 1961. Current Practices and New Developments In Sterility Testing. PDA Bulletin of Parenteral Drug Assoc. 15:15-20.
  • Mayernik, J. 1961. Evaluation of Product Sterility . PDA Bulletin of Parenteral Drug Assoc. 15:25-32.
  • Gay, PM. 1960. Application De Nouvelles Methodes a La Pratique Courante De L’Epreuve De Sterilite Des Medicaments Injectables. Pharm Acta Helv. 35:555-574.
  • Lagodsky, H. 1960. Le Dosage D’Accompagnement Dans L’Epreuve De Sterilite Par Filtration De Droduits Antimicrobiens. Compt Rend Soc Biol. 154:1435.
  • USP. 1960. Sterility Tests. USP XVI. pp. 855.
  • WHO. 1960. Who Technical Reort Series No. 200: Requirements for Biological Substances – 6. General Requirements for the Sterility of Biological Substances. Hlth Org Techn Rep Ser. 200 .
  • Holdowsky, S. 1957. A New Sterility Test for Antibiotics: an Application of the Membrane Filter Technique. Antibiotics and Chemotherapy. 7 .
  • Schaufus, CP. 1957. An Improved Technique for More Rapid Sterility Determinations of Parenterals. PDA Bulletin of Parenteral Drug Assoc. 11:1-7.
  • Bryce, DM. 1956. Tests for the Sterility of Pharmaceutical Preparations. J Pharm Pharmacol. 8:561-572.
  • Sykes, G. 1956. The Technique of Sterility Testing. J Pharm Pharmacol. 8:573-588.
  • USP. 1955. Sterility Tests. USP XV. pp. 841-846.
  • Carter, EB. 1953. Methods of Sterilization and Sterility Testing. PDA Bulletin of Parenteral Drug Assoc. 7:1-14.
  • Vera, HD. 1953. False Negative Results On Sterility Testing. PDA Bulletin of Parenteral Drug Assoc. 7:7-11.
  • USP. 1950. Sterility Tests. USP XV. pp. 841.
  • USP. 1950. Sterility Test for Liquids and Solids. USP XIV. pp. 758-762.
  • Knudsen, LF. 1949. Sample Size of Parenteral Solutions for Sterility Testing. J Amer Pharm Assoc. 38:332-337.
  • USP. 1947. Sterility Test for Liquids and Solids. USP XIII. pp. 689-691.
  • USP. 1942. Sterility Test for Liquids & Sterility Test for Solids. USP XII. pp. 609.
  • USP. 1942. Sterility Test for Liquids. USP XII. pp. 609-614.
  • USP. 1939. Sterility Test for Solids. USP XI (2nd Suppl). pp. 124-129.
  • USP. 1935. Sterility Test for Liquids. USP XI. pp. 469.
  • Brit Pharm. 1932. Tests for Sterility. Brit Pharm. pp. 632.

Bacterial Endotoxin Test

  • Park, J-H et al. 2004. Characterization of Lipopolysaccharides Present in Settled House Dust. Appl Environ Microbiol. 70:262-267.
  • Cooper, Murray. 2003. Bacterial Endotoxins, Testing-Container Sterility Integrity. Microbiological Update. 21 .
  • FujII, S et al. 2002. Wet Heat Inactivation of Lipopolysaccharide From E coli Serotype 055:B5. PDA J Pharm Sci Tech. 56:220-227.
  • USP. 2000. <85> Bacterial Endotoxins Test Harmonization. Pharm Forum. 26:218-229.
  • Piluson, LG and MY Martinez. 1999. Resolving Liposomal Inhibition of Quantitative LAL Methods. PDA J Pharm Sci Tech. 53:260-263.
  • Poxon, SW and JA Hughes. 1999. Foam Fractionation As a Method to Separate Endotoxin From Recombinant Biotechnology Products. PDA J Pharm Sci Tech. 53:23-26.
  • Bamba, T, et al. 1997. Enhancing Effect of Non-Ionic Surfactant On the Inactivation of Lipopolysaccharide by Heat Treatment II. PDA J Pharm Sci Tech. 51:156-160.
  • Cooper, J.F., et al. 1997. The Impact of Non-Endotoxin Lal-Reactive Materials On Limulus Amebocyte Lysate Analyses. PDA J Pharm Sci Tech. pp. 2-6.
  • Cooper, Murray. 1997. Bacterial Endotoxins and Container-Closure Integrity. Microbiological Update. 15 .
  • Fulk,G.,et al. 1997. Endotoxin Concentration In Contact Lens Storage Cases. J Amer Optom Assoc. pp. 296-300.
  • Bamba, T, et al. 1996. Effect of Steam-Heat Treatment With/Without Divalent Cations On the Inactivation of Lipopolysaccharides From Several Bacterial Species. PDA J Pharm Sci Tech. 50:129-135.
  • Bamba, T, et al. 1996. Enhancing Effect of Non-Ionic Surfactant On the Inactivation of Lipopolysaccharide by Heat Treatment I. PDA J Pharm Sci Tech. 50:360-365.
  • Cooper, Murray. 1996. Bacterial Endotoxins. Microbiological Update. 14 .
  • Evans-Strickfaden, TT et al. 1996. Endotoxin Removal Using 6,000 Molecular Wt. Cut Off Polyacrylonitrile (Pan) and Polysulfone (Ps) Hollow Fiber Ultrafilters. PDA J Pharm Sci Tech. 50:154-157.
  • JP. 1996. 6. Bacterial Endotoxins Test. JP XIII. pp. 20-24.
  • Rafiee-Tehrani, M et al. 1996. Removal of Lipid a and Pseudomonas aeruginosa Endotoxin From Dialysis Fluids by High-Flux Polysulfone Ultrafilter (Dialyzer). PDA J Pharm Sci Tech. 50:306-310.
  • Duner, K.I. 1995. The Importance of the Quality of Water In Limulus Amebocyte Lysate Tests. PDA J Pharm Sci Tech. pp. 119-121.
  • Cooper, Murray. 1994. Bacterial Endotoxin Testing (Bet). Microbiological Update. 12 .
  • Hecker, W., et al. 1994. Validation of Dry Heat Inactivation of Bacterial Endotoxins. PDA J Pharm Sci Tech. pp. 197-204.
  • Iwanaga, S. 1994. Biochemical Principle of Limulus Clotting Reaction. PDA Asian Symposium 11/14/94. 48:45-51.
  • Nakata, T. 1994. Destruction of Challenged Endotoxin In a Dry Heat Oven. PDA J Pharm Sci Tech. pp. 59-63.
  • Walters, M et al. 1994. Airborne Environmental Endotoxin: a Cross-Validation of Sampling and Analysis Technique. Appl Environ Microbiol. 60:996-1005.
  • Brown, S and AC Fuller. 1993. Depyrogenation of Pharmaceutical Solutions Using Submicron and Ultrafilters. PDA J Parenteral Sci Tech. 47:285-288.
  • Justicia, H and M Ibanez. 1993. An Approach to the Determination of Endotoxin In Anesthetics and Antibiotics: Use of an Ultrafiltration System and Enzymatic LAL Reaction. PDA J Parenteral Sci Tech. 47:205-210.
  • Nakata, T. 1993. Destruction of Typical Endotoxins by Dry Heat As Determined Using LAL Assay and Pyrogen Assay. PDA J Parenteral Sci Tech. 47:258-264.
  • Nakata, T and N. Ogino. 1993. Development of a Convenient Measurement System for the Destruction Rate of Endotoxins by Dry Heat. J Antibact Antifung Agents. 21:431-437.
  • Cooper, Murray. 1992. Pyrogen and Bacterial Endotoxin Testing (Bet). Microbiological Update. 9 .
  • McCullough, KZ, and C. Weidner-Loeven. 1992. Variability In the LAL Test: Comparison of Three Kinetic Methods for the Testing of Pharmaceutical Products. PDA J Parenteral Sci Tech. 46:69-72.
  • Tsuchiya, M et al. 1992. Limulus Amebocyte Lysate Test for Medical Devices. J Antibact Antifung Agents. 20:139-145.
  • Adner, N et al. 1991. Collaborative Study of a Control Standard Endotoxin Using the Limulus Amebocyte (Gel-Clot) Test. PDA J Parenteral Sci Tech. 45:?.
  • Ludwig, JD and KE Avis. 1991. Dry Heat Inactivation of Rough Strain Lipopolysaccharide and Diphospryl Lipid a On the Surface of Glass. PDA J Parenteral Sci Tech. 45:35-40.
  • Novitsky,T.J. 1991. Interum Guidance for Human and Veterinary Drug Products and Biologicals. LAL Update. pp. 1-6.
  • Ogawa, YT et al. 1991. Endotoxin Tests for Medical Devices. the Correlation of the LAL Test with the Pyrogen Test. J Antibact Antifung Agents. 19:561-566.
  • Roslansky, PF et al. 1991. Plastics, Endotoxins, and the Limulus Amebocyte Lysate Test. PDA J Parenteral Sci Tech. 45:83-87.
  • White, et al. 1991. Detection of Endotoxins of Gram Negative Bacteria. US Patent. pp. 1-8.
  • Cooper, JF. 1990. Resolving LAL Test Interferences. PDA J Parenteral Sci Tech. pp. 13-15.
  • Hou, K.C., et al. 1990. Depyrogenation by Endotoxin Removal with Positively Charged Depth Filter Cartridge. PDA J Parenteral Sci Tech. 44:204-210.
  • Ludwig, JD and KE Avis. 1990. Dry Heat Inactivation of Endotoxin On the Surface of Glass. PDA J Parenteral Sci Tech. 44:4-12.
  • Mccullough, KZ. 1990. Variability In the LAL Test. PDA J Parenteral Sci Tech. 44:19-21.
  • PDA QA/QC Task Force. 1990. Current Practices In Endotoxin and Pyrogrn Testing In Biotechnology. PDA J Parenteral Sci Tech. 44:39-45.
  • Raetz, CRH. 1990. Biochemistry of Endotoxins. Ann Rev Biochem. 59:129-170.
  • Roslansky,P.F. 1990. Reactivity of Limulus Amebocyte Lysate (Lal) to Glucans. LAL Update. 8:2-4.
  • Schadewald, LK et al. 1990. Automation and Computerization of Chromogenic LAL Assay Method for Bacterial Endotoxin Using 96-Well Plate. PDA J Parenteral Sci Tech. 44:50-53.
  • Weary, ME. 1990. Understanding and Setting Endotoxin Limits. PDA J Parenteral Sci Tech. pp. 16-18.
  • Guilfoyle, DE, et al. 1989. The Effect of Refrigeration and Mixing On Detection of Endotoxin In Parenteral Drugs Using the LAL Test. PDA J Parenteral Sci Tech. pp. 183-187.
  • Lacasa, C, and FA Vega. 1989. Pyrogens In Small-Volume Parenterals Prepared In Hospital Pharmacy. PDA J Parenteral Sci Tech. 43:245-249.
  • LAL User’s Group. 1989. Preparation and Use of Endotoxin Indicators for Depyrogenation Process Studies. PDA J Parenteral Sci Tech. 43:109-112.
  • Ludwig, JD and KE Avis. 1989. Recovery of Endotoxin Preparation From the Surface of Glass Capillary Tubes. PDA J Parenteral Sci Tech. 43:276-278.
  • Tsuji, T. 1989. Expert System Computer Program for Troubleshooting the Gel-Clot Limulus Amebocyte Lysate (Lal) Assay. PDA J Parenteral Sci Tech. 43:240-245.
  • USP. 1989. <85> Bacterial Endotoxins Test. USP XXII. pp. 1493-1495.
  • Cooper, Murray. 1988. Lal Topics. Microbiological Update. 5 .
  • Ludwig, JD and KE Avis. 1988. Validation of a Heating Cell for Precisely Controlled Studies On the Thermal Destruction of Endotoxin In Glass. PDA J Parenteral Sci Tech. 42:9-14.
  • Avis, KE et al. 1987. Studies On the Thermal Destruction of Eschericia coli Endotoxin. PDA J Parenteral Sci Tech. pp. 49-56.
  • Berman, D et al. 1987. Cycle Development Criteria for Removal of Endotoxin by Dilution From Glassware. PDA J Parenteral Sci Tech. 41:158-163.
  • FDA. 1987. Guideline On Validation of the Limulus Amebocyte Lysate Test As an End Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices. FDA Guidance.
  • Mosier, LD et al. 1987. The Effects of Ph, Time, Temperature and Autoclaving On E. coli Endotoxin In Selected Parenteral Solutions. PDA J Parenteral Sci Tech. 41:21-25.
  • Murai, T et al. 1987. Physiology of the Potentiation of Lethal Endotoxin Shock by Streptococcal Pyrogenic Exotoxin In Rabbits. Infect Immun. 55:2456-2460.
  • Wolber, P and M Dosmar. 1987. Depyrogenation of Pharmaceutical Solutions by Ultrafiltration: Aspects of Validation. Pharm Technol. Sept:38-46.
  • Wolber,P.,et al. 1987. Depyrogenation of Pharmaceutical Solutions by Ultrafiltration: Validation. Pharm Technol. pp. 38-46.
  • Cooper, Murray. 1986. Endotoxin Topics. Microbiological Update. 4 .
  • Kanegasaki, SK et al. 1986. Structure-Activity Relationship of Lipid A: Comparison of Biological Activities of Natural and Synthetic Lipid As with Different Fatty Acid Compositions. J Biochem. 99:1203-1210.
  • Martin, PA et al. 1986. Automation of Microtiter Plate – Chromogenic Substrate LAL Endotoxin Assay Method by Use of a Modified Cetus Pro/Pette Express System. PDA J Parenteral Sci Tech. 40:61-66.
  • Novitsky, TJ et al. 1986. Factors Affecting Recovery of Endotoxin Adsorbed to Container Surfaces. PDA J Parenteral Sci Tech. pp. 284-286.
  • Twohy, CW and AP Duran. 1986. Extraction of Bacterial Endotoxin From Medical Devices. PDA J Parenteral Sci Tech. 40:287-291.
  • Yano, S et al. 1986. Determination of Endotoxin In Injectable Antibiotic Preparations by the Chromogenic Assay Method Using a Limulus Reagent (Tachypleus Hemocyte Lysate) and a Chromogenic Substrate. J Clin Microbiol. 23:11-16.
  • Baggerman,C.,et al. 1985. Endotoxin Removal From Large Volume Parenterals by Various Adsorbents. Int J Pharmaceutics. 27:17-27.
  • Brandin,E.R. 1985. Presence of Microorganisms In Hemolymph of the Horseshoe Crab Limulus Polyphemus. Appl Environ Microbiol. 49:718-720.
  • Cooper, Murray. 1985. Pyrogens and Endotoxin Topics. Microbiological Update. 3 .
  • Guilfoyle, DE and JD Macmillan. 1985. Evaluation of a Chromogenic Procedure for Use with the Limulus Assay of Bacterial Endotoxins In Drug Products. PDA J Parenteral Sci Tech. 39:233-236.
  • Homma, JY et al. 1985. Structural Requirements of Lipid a Responsible for the Functions: a Study with Chemically Synthesized Lipid a and Its Analogues. J Biochem. 98:395-406.
  • Obayashi, T, et al. 1985. A New Chromogenic Endotoxin-Specific Assay Using Recombined Limulus Coagulation Enzymes and Its Clinical Applications. Clin Chim Acta. 149:55-65.
  • Oishi, H, et al. 1985. Automated Limulus Amebocyte Lysate (Lal) Test for Endotoxin Analysis Using a New Toxinometer Et-20. PDA J Parenteral Sci Tech. 39:194-200.
  • Paulssen,J.,et al. 1985. Ultrafiltration As a Means to Eliminate Inhibition of the LAL Assay. Acta Path Microbiol Immunol Scand. 93:73-75.
  • PDA. 1985. PDA Tech Report #7: Depyrogenation. PDA J Parenteral Sci Tech. 39 .
  • Pearson, FC et al. 1985. Comparison of Several Control Standard Endotoxins to the National Reference Standard Endotoxin-An Hima Collaborative Study. Appl Environ Microbiol. 50:91-93.
  • Pearson, FC et al. 1985. Detection of Endotoxin In the Plasma of Patients with Gram-Negative Bacterial Sepsis by the Limulus Amoebocyte Lysate Assay. J Clin Microbiol. 21:865-868.
  • Pound, NJ. 1985. Lal: a Canadian Perspective. PDA J Parenteral Sci Tech. 39:186-189.
  • Bussey, DM and K Tsuji. 1984. Optimization of a Chromogenic Limulus Amebocyte Lysate (Lal) Assay for Automated Endotoxin Detection. PDA J Parenteral Sci Tech. 38:228-233.
  • Kannegieter, E.M. et al. 1984. A New Method to Reduce Electrolyte Inhibition of the Detection of Endotoxin In Large Volume Parenterals. PDA J Parenteral Sci Tech. 38:17-20.
  • Pearson, FC et al. 1984. Characterization of Limulus Amoebocyte Lysate-Reactive Material From Hollow-Fiber Dialyzers. Appl Environ Microbiol. 48:1189-1196.
  • Tsuji K, Martin PA, Bussey DM. 1984. Automation of Chromogenic Substrate Limulus Amebocyte Lysate Assay Method for Endotoxin by Robotic System. Appl Environ Microbiol. 48:550-555.
  • Twohy, CW, AP Duran and TE Munson. 1984. Endotoxin Contamination of Parenteral Drugs and Radiopharmaceuticals As Determined by the Lumulus Amebocyte Lysate Method. PDA J Parenteral Sci Tech. 38:190-201.
  • USP. 1984. <85> Bacterial Endotoxins Test. USP XXI. pp. 1165-1167.
  • Wearly, M. 1984. Pyrogen Testing of Parenteral Products – Status Report. PDA J Parenteral Sci Tech. 38:20-23.
  • Hochstein, H.D. 1983. The Processing and Collaborative Assay of a Reference Endotoxin. J Biological Standardization. 11:251-260.
  • Novitsky, TJ. 1983. Letters to the Editor: Effect of Nonsterility On Lal. PDA J Parenteral Sci Tech. 37:108-109.
  • Tsuji K, Steindler KA. 1983. Use of Magnesium to Increase Sensitivity of Limulus Amoebocyte Lysate for Detection of Endotoxin. Appl Environ Microbiol. 45:1342-1350.
  • Twohy, CW et al. 1983. Comparison of Limulus Amebocyte Lysates From Different Manufacturers. PDA J Parenteral Sci Tech. 37:93-96.
  • Akers, M. et al. 1982. F Value Requirements for the Destruction of Endotoxin In the Validation of Dry Heat Sterilization/Depyrogenation Cycles. PDA J Parenteral Sci Tech. 36:24-27.
  • Novitsky, TJ, et al. 1982. Automated LAL Testing of Parenteral Drugs In the Abbott Ms-2. PDA J Parenteral Sci Tech. 36:11-16.
  • Pearson, FC et al. 1982. Effect of Nonsterility On the Activity of the Limulus Amebocyte Lysate. PDA J Parenteral Sci Tech. 36:196-199.
  • Tutunjian,R.S. 1982. Pyrogen Removal by Ultrafiltration. Endotoxins and Their Detection with the Limulus Amebocyte Lysate Test. pp. 319-327.
  • Abramson, D. et al. 1981. Depyrogenation of a Parenteral Solution by Ultrafiltration. PDA J Parenteral Sci Tech. 35:3-7.
  • Steindler, KA et al. 1981. Potentiating Effect of Calcium Gluconate On the Limulus Amebocyte Lysate (Lal) Geltation-Endpoint Assay for Endotoxin. PDA J Parenteral Sci Tech. 35:242-7.
  • Dabbah, R et al. 1980. Pyrogenicity of E coli 055:B5 Endotoxin by the USP Rabbit Test – a Hima Collaborative Study. PDA J Parenteral Drug Assoc. 34:212-216.
  • Murphy, CA and TR Aneiros. 1980. 99M Tc-Radiopharmaceutucals and the Limulus Test. PDA J Parenteral Drug Assoc. 34:268-271.
  • PDA. 1980. Response to Food and Drug Administration Guideline for Use of Limulus Amebocyte Lysate . PDA J Parenteral Drug Assoc. 34 .
  • Pearson, FC and M Weary. 1980. The Significance of Limulus Amebocyte Lysate Test Specificity On the Pyrogen Evaluation of Parenteral Drugs. PDA J Parenteral Drug Assoc. 34:103-108.
  • Tsuji K, Steindler KA, Harrison SJ. 1980. Limulus Amoebocyte Lysate Assay for Detection and Quantitation of Endotoxin In a Small-Volume Parenteral Product. Appl Environ Microbiol. 40:533-538.
  • USP. 1980. <85> Bacterial Endotoxins Test. USP XX. pp. 888-889.
  • Weary, ME et al. 1980. Relative Potencies of Four Reference Endotoxin Standards As Measured by the Limulus Amoebocyte Lysate and USP Rabbit Pyrogen Tests. Appl Environ Microbiol. 40:1148-1151.
  • Feldsine, PT et al. 1979. A New Concept In Glassware Depyrogenation Process Validation. PDA J Parenteral Drug Assoc. 33:125-131.
  • Harrison, Susan J. 1979. Application of LAL for Detection of Endotoxin In Antibiotic Preparations. Biomedical App of the Horseshoe Crab (Limulidae). pp. 353-365.
  • Haska,G. 1979. Determination of Endotoxins In Sugar with the Limulus Test. Appl Environ Microbiol. pp. 1078-1080.
  • Mascoli, CC and ME Weary. 1979. Limulus Amebocyte Lysate Test for Detecting Pyrogens In Parenteral Injectable Products and Medical Devices: Advantages to Manufacturers and Regulatory Officials. PDA Bulletin of Parenteral Drug Assoc. pp. 81-95.
  • Rastogi, SC et al. 1979. Statistical Procedure for Evaluating the Sensitivity of Limulus Amoebocyte Lysate by Using a Reference Lysate. Appl Environ Microbiol. 38:911-915.
  • Tsuji, K and AR Lewis. 1978. Dry-Heat Destruction of Lipopolysaccharide: Mathematical Approach to Process Evaluation. Appl Environ Microbiol. 36:715-719.
  • Tsuji, K and SJ Harrison. 1978. Dry-Heat Destruction of Lipopolysaccharide: Dry-Heat Destruction Kinetics. Appl Environ Microbiol. 36:710-714.
  • Weiss, PJ. 1978. Pyrogen Testing. PDA J Parenteral Drug Assoc. 32:236-241.
  • Armistead, RL and NL Taylor. 1977. Design and Operation of an In-HoUse Pyrogen Test Facility. PDA Bulletin of Parenteral Drug Assoc. 31:14-17.
  • Cooper, JF. 1977. Panel Discussion: Developing Role of the Limulus Test In Pyrogen Testing. PDA Bulletin of Parenteral Drug Assoc. pp. 114-135.
  • Orth, D.S. 1977. Statistical Analysis and Quality Control In Radioimmunoassays for Staphylococcal Enterotoxins A, B, and C. Appl Environ Microbiol. 34:710-714.
  • Wachtel, RE and K Tsuji. 1977. Comparison of Limulus Amebocyte Lysates and Correlation with the United States Pharmacopeial Pyrogen Test. Appl Environ Microbiol. pp. 1265-1269.
  • Daoust, DR et al. 1976. Limulus Amebocyte Lysate Test As a Method for Detection of Endotoxins and Endotoxin-Like Materials. PDA Bulletin of Parenteral Drug Assoc. 30:13-20.
  • Cooper, J.F. 1975. Principles and Applications of the Limulus Test for Pyrogen In Parenteral Drugs. PDA Bulletin of Parenteral Drug Assoc. 29:122-130.
  • Sullivan, JD and SW Watson. 1974. Factors Affecting the Sensitivity of Limulus Lysate. Appl Microbiol. 28:1023-1026.
  • Hochstein, HD et al. 1973. Further Developments of Limulus Amebocyte Lysate Test. PDA Bulletin of Parenteral Drug Assoc. pp. 139-148.
  • Jorgensen. 1973. Rapid Detection of Contaminated Intravenous Fluids Using the Limulus In Vitro Endotoxin Assay. Appl Microbiol. pp. 521-524.
  • Cooper, JF et al. 1972. The Limulus Test for Endotoxin (Pyrogen) In Radiopharmaceuticals and Biologicals. PDA Bulletin of Parenteral Drug Assoc. pp. 153-162.
  • Eibert, Jr, J. 1972. Pyrogen Testing: Horseshoe Crabs vs Rabbits. PDA Bulletin of Parenteral Drug Assoc. 26:253-260.
  • PDA. 1971. Editorial: Pyrogens. PDA Bulletin of Parenteral Drug Assoc. 25:209.
  • Selzer, GB. 1970. Preparation of a Purified Lipopolysaccharide for Pyrogen Testing. PDA Bulletin of Parenteral Drug Assoc. 24:153-156.
  • Castor, G.B. 1969. Pyrogens: Their Nature and Measurement In Parenterals. PDA Bulletin of Parenteral Drug Assoc. 23:23-28.
  • Lamey, et al. 1969. Some Aspects of the USP Pyrogen Test. PDA Bulletin of Parenteral Drug Assoc. pp. 245-251.
  • Personeus, G.R. 1969. Pyrogen Testing of Biologicals and Small Volume Parenterals. PDA Bulletin of Parenteral Drug Assoc. 23:201-207.
  • Leive, L. 1965. Release of Lipopolysaccharide by EDTA Treatment of E. coli. Biochem Biophys Res Comm. 21:290-296.
  • Marcus, S. 1964. Determination of Pyrogens Using Membrane Filtration. PDA Bulletin of Parenteral Drug Assoc. 18:18-24.
  • Martin, WJ and S Marcus. 1964. Relation of Pyrogenic and Emetic Properties of Enterobacteriaceal Endotoxin and of Staphylococcal Enterotoxin. J Bacteriol. 87:1019-1026.
  • Varney, R. 1962. The Intruders – Pyrogens. PDA Bulletin of Parenteral Drug Assoc. 16:6-12.
  • Braun, H and VV Klein. 1960. Some Problems of Pyrogen Testing. PDA Bulletin of Parenteral Drug Assoc. 14:9-15.
  • Gee, AH. 1954. Factors Influencing the Pyrogen Test. PDA Bulletin of Parenteral Drug Assoc. 8:12-16.
  • Welch, HC et al. 1945. The Thermostability of Pyrogens and Their Removal From Penicillin. J Amer Pharm Assoc. 34:114-118.
  • Siebert, FB. 1923. Fever-Producing Substance Found In Some Distilled Waters. Amer J Physiol. 67:90-104.