Impurities - Where are we now?

Pharmaceutical Technology

Volumn 21, Issue 6, 1997, Pages 56-60

  Boehlert, Judy P ^a,b  

^a Editorial Advisory Board ^*  (United States)

^b Sanofi Pasteur   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DRUG CONTROL; DRUG PURIFICATION; DRUG PURITY; DRUG SAFETY; DRUG SCREENING; GOOD MANUFACTURING PRACTICE; QUALITY CONTROL;

EID: 0030838553     PISSN: 01478087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (14)

1. FDA Ad Hoc Advisory Committee, "Impurity Testing Protocols," Washington, DC, June 1993.
2. L.T. Grady, "Toward Rapid Progress on USP Drug Substance Purity Standards," Pharm. Forum, Sept./Oct. 1981.
3. USP Open Conference on Drug Substance Purity, Alexandria, VA, Oct. 1986.
4. USP Open Conference on Current Revision Issues, Williamsburg, VA, May 1989.
5. USP Open Conference on Current Revision Issues, Chicago, IL, May 1995.
6. Fourteenth Interim Revision Announcement, Pharm. Forum, Nov./ Dec. 1996.
7. "Concepts for Establishing Rational Drug Substance Impurity Limits," Report of PMA Committee, J.P. Boehlert, chair, Pharm. Forum, Sept./Oct. 1987.
8. "Procedures for Setting Limits for Volatile Organic Solvents with Methylene Chloride as an Example of the Process," Report of PMA Committee, J.P. Boehlert, chair, Pharm. Forum, Nov./Dec. 1989.
9. "Application of the PMA Procedure for Setting Limits for Organic Volatile Solvents in Pharmaceuticals to Ethylene Oxide," Report of PMA Committee, J.P. Boehlert, chair, Pharm. Forum, May/June, 1990.
10. "Application of the PMA Procedure for Setting Limits for Organnic Volatile Solvents in Pharmaceutical to 1,4-Dioxane," Report of PMA Committee, J.P. Boehlert, chair, Pharm. Forum, May/June, 1990.
11. "Application of the PMA Procedure for Setting Limits for Organic Volatile Solvents in Pharmaceuticals to Chloroform," Report of PMA Committee, J.P. Boehlert, chair, Pharm. Forum, May/June, 1990.
12. "Application of the PMA Procedure for Setting Limits for Organic Volatile Solvents in Pharmaceuticals to Trichloroethylene," Report of PMA Committee, J.P. Boehlert, chair, Pharm. Forum, May/June, 1990.
13. "Application of the PMA Procedure for Setting Limits for Organic Volatile Solvents in Pharmaceuticals to Benzene," Report of PMA Committee, J.P. Boehlert, chair, Pharm. Forum, Jan./Feb. 1991.
14. FDA, "Guideline for Submitting Documentation in Drug Applications for the Manufacture of Drug Substances," Feb. 1987.