Pharmaceutical impurities - A mini-review

AAPS PharmSciTech

Volumn 3, Issue 2, 2002, Pages

  Roy, Jiben ^a  

^a Salem International University   (United States)

Author keywords

Bulk drugs; Degradation; Drug stability; Formulation; Impurities

Indexed keywords

4 AMINOPHENOL; ACETYLSALICYLIC ACID; AMPICILLIN; BENZOCAINE; CEFOTAXIME; CEFPODOXIME PROXETIL; CEPHALOSPORIN DERIVATIVE; CHARCOAL; COCAINE; DICLOFENAC; ECOTHIOPATE; ESOMEPRAZOLE; FLUOCINONIDE; HEAVY METAL; HYDROCORTISONE; LEVALBUTEROL; LEVOFLOXACIN; LIGAND; METHOTREXATE; NICOTINAMIDE; OFLOXACIN; PARACETAMOL; PENICILLIN G; PYRIDOXINE; RIBOFLAVIN; SOLVENT; THIAMINE; TRIETHYLAMINE; UNINDEXED DRUG; VITAMIN;

CRYSTALLIZATION; DECARBOXYLATION; DEGRADATION KINETICS; DRUG DOSAGE FORM; DRUG EFFICACY; DRUG FORMULATION; DRUG IMPURITY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG PACKAGING; DRUG SAFETY; DRUG STABILITY; DRUG STORAGE; DRUG STRUCTURE; ENANTIOMER; ENVIRONMENTAL FACTOR; ENVIRONMENTAL TEMPERATURE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMIDITY; HYDROLYSIS; ION CYCLOTRON RESONANCE MASS SPECTROMETRY; MASS SPECTROMETRY; MEDICAL LITERATURE; MICROBIAL CONTAMINATION; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; OXIDATION; PHOTOLYSIS; PRACTICE GUIDELINE; QUANTITATIVE ANALYSIS; SHELF LIFE; SHORT SURVEY; STANDARD; TANDEM MASS SPECTROMETRY; ULTRAVIOLET RADIATION; DRUG CONTAMINATION; REVIEW;

DRUG CONTAMINATION; DRUG STABILITY;

EID: 23144461485     PISSN: 15309932     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/pt030206     Document Type: Short Survey

References (28)

1. International Conferences on Harmonization, Draft Revised Guidance on Impurities in New Drug Substances. Q3A(R). Federal Register. 2000;65(140):45085-45090.
2. International Conferences on Harmonization, Draft Revised Guidance on Impurities in New Drug Products. Q3B(R). Federal Register. 2000;65(139):44791-44797.
3. International Conferences on Harmonization, Impurities- Guidelines for Residual Solvents. Q3C. Federal Register. 1997;62(247):67377.
4. Ahuja S. Impurities Evaluation of Pharmaceuticals. New York: Marcel Dekker; 1998.
5. Gorog S. Identification and Determination of Impurities in Drugs. Amsterdam: Elsevier Science Publishing Company; 2000.
6. Alsante KM, Hatajik TD, Lohr LL, and Sharp TR. Isolation and identification of process related impurities and degradation products from pharmaceutical drug candidates. Part 1. American Pharmaceutical Review. 2001; 4(1):70-78.
7. Lohr LL, Sharp TR, Alsante KM, and Hatajik TD. Isolation and identification of process related impurities and degradation products from pharmaceutical drug candidates. Part II: The roles of NMR and mass spectrometry. American Pharmaceutical Review. Fall issue 2001; Available at: http://www.americanpharmaceuticalreview.com/past_articles_f.htm.
8. Winger BE, Kemp CAJ. Characterization of pharmaceutical compounds and related substances by using HPLC FTICR-MS and tandem mass spectrometry. American Pharmaceutical Review. Summer issue 2001; Available at: http://www.americanpharmaceuticalreview.com/past_articles_f.htm.
9. Van Krimpen, PC, Van Bennekom WP, and Bult A. Penicillins and cephalosporins: physicochemical properties and analysis in pharmaceutical and biological matrices. Pharm Weekbl [Sci].1987;9:1-23.
10. Roy J, Mohammad G, and Banu A. Pharmaceutical analysis and stability of locally manufactured ampicillin trihydrate. Indian Drugs. 1993;5(30)5:211-218.
11. British Pharmacopoeia. The British Pharmacopoeia Commission, Vol 1. The Stationary Office, London, UK;2001:123,128.
12. Riley TN. Steric aspects of drug action. US Pharmacist. 1998;23(3):40-51.
13. Roy J, Islam M, Khan AH, Das SC, Akhteruzzaman M, Deb AK, Alam AH M. Diclofenac sodium injection sterilized by autoclave and the occurrence of cyclic reaction producing a small amount of impurity. J Pharm Sci. 2001;(90):541-544.
14. Walker GJA, Hogerzeil HV, Hillgreen U. Potency of ergometrine in tropical countries. Lancet. 1988;2:393.
15. Hogerzeil HV, Battersby A, Srdanovic V, and Stjernstrom NE. Stability of essential drugs during shipment to the tropics. BMJ. 1992;304:210-214.
16. Roy J, Bhuiyan K, Faruque A, Sobahan M, Al-Farooque M. Injectable ergometrine: stability and packaging for developing countries. Indian Drugs. 1997;34(11):634-636.
17. Food and Drug Administration for immediate release consumer media: 888-Info-FDA. May 6, 1998.
18. Hoq MM, Morsheda SB, and Gomes DJ. Development of appropriate preservative system for liquid antacid: bacterial contaminants in antacid samples. Bang J Microbiology. 1991;8(1):5-9.
19. Buhler V. Vademecum for Vitamin Formulation. Stuttgart, Germany: Wiss. Verl-Ges; 1988.
20. Roy J, Mahmud M, Sobhan A, Aktheruzzaman M, Al-Faooque M, Ali E. Marketed vitamin B-complex injectables: stability and mutual interaction. Drug Dev. and Ind Pharm. 1994;20(13):2157-2163.
21. Connor KA, Amidon GL, Stella VJ. Chemical Stability of Pharmaceuticals-A Handbook for Pharmacists. New York: John Wiley & Sons; 1986.
22. Hoerle SL, Evans KD, and Snider BG. HPLC Determination of Impurities in a 3rd Generation Cephalosporin. Eastern Analytical Symposium. November 16-20, 1992, Somerset, New Jersey.
23. Kumar V, Sunder N, and Potdar A. Critical factors in developing pharmnaceutical formulations- An overview. Part II. Pharmaceutical Technology. 1992;16:86-88.
24. Smith A, Pennefather PM, Kaye S B, and CA Hart CA. Fluoroquinolones - place in ocular therapy. Drugs. 2001;61(6):747-761.
25. Tobin C. Sunlight, eyes and light-sensitive antibiotics, Southmead Hospital Bristol, University of Bristol. Available at: http://www.irisfund.org.uk/sunlight.htm. Accessed October 27, 2001.
26. Sunderland J, Tobin CM, White LO, MacGowan AP, and Hedges AJ. Ofloxacin photodegradation products possess antimicrobial activity. Drugs. 1999; 58(Suppl 2):171-172.
27. Roy J, Das SC. The effect of sunlight on ciprofloxacin eye drops. In press.
28. Condorelli G, De Guidi G, Giulfrido S, Sortino S, Chilleni R, and Sciuto S. Molecular mechanisms of photosensitization induced by drugs XII. Photochemistry and photosensitization of rufloxacin: An unusual photodegradation path for the antibacterials containing a fluoroquinolone-like chromophore. Photochemistry & Photobiology. 1999;70(3):280-286.