Identification and characterization of new degradation products of cefepime dihydrochloride monohydrate drug substance during stress stability studies

Analytical Sciences

Volumn 26, Issue 10, 2010, Pages 1081-1086

  Jagadeesh Kumar, Vundavilli ^a   Badarinadh Gupta, P ^a   Pavan Kumar, Kothapalli S R ^a   Prasada Rao, Korrapati V V ^a   Rao, K Ranga ^a   Prasanna, S John ^a   Kumar Sharma, Hemant ^a   Mukkanti, K ^b  

^a Aurobindo Pharma Ltd   (India)

^b JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY   (India)

Author keywords

[No Author keywords available]

Indexed keywords

CARBOXYLATION; DEGRADATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY;

DEGRADATION PRODUCTS; DRUG SUBSTANCES; RELATIVE RETENTION TIME; RETENTION TIME; REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; SPECTRAL DATA; STRESS STABILITY; STRUCTURAL ELUCIDATION;

DRUG PRODUCTS;

EID: 77957890398     PISSN: 09106340     EISSN: 13482246     Source Type: Journal    
DOI: 10.2116/analsci.26.1081     Document Type: Article

References (13)

1. M. P. Okamoto, R. K. Nakahiro, A. Chin, A. Bedikian, and M. A. Gill, Am. J. Hosp. Pharm., 1994, 51, 463.
2. M. A. Wynd and J. A. Paladino, Ann. Pharmacother., 1996, 30, 1414.
3. Package Insert Maxipime (Cefepime), Princeton, NJ, Bristol-Myers Squibb Co., 1996.
4. T. M. Chapman and C. M. Perry, Am. J. Respir. Med., 2003, 2, 75.
5. "United States Pharmacopoeia", 2009
6. "European Pharmacopoeia 6.5", 2009.
7. K. V. V. Prasada Rao, D. Ramesh, V. K. Handa, A. G. Kamat, I. V. S. Rao, A. Rani, and A. Naidu, J. Heterocycl. Chem., 2007, 44, 1513.
8. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q3A (R2): Impurities in New Drug Substances, Geneva, 2006, http://www.ich.org/cache/compo/276-254-1.html.
9. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q1A (R2): Stability Testing of New Drug Substances and Products, Geneva, 2003, http://www.ich.org/cache/compo/276-254-1.html.
10. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q1B (R2): Photo Stability Testing of New Drug Substances and Products, Geneva, 1996, http://www.ich.org/cache/compo/276-254-1.html.
11. A. Manca, R. Monguzzi, M. Zenoni, and L. Marsili,. U. S. Patent, 2006, 0100424 A1.
12. A. Manca, R. Monguzzi, M. Zenoni, and L. Marsili,. U. S. Patent, 2009, 7479556 B2.
13. R. M. Silverstein and F. X. Webster,. "Spectrometric Identification of Organic Compounds", 6th ed., 1997, Chap. 3, John Wiley and Sons, New York, Chichester, Brisbane, Singapore, Toronto.