GC Quantification of Cyclopropylamine, Diethylamine and Triethylamine in Active Pharmaceutical Ingredients

Chromatographia

Volumn 71, Issue 9-10, 2010, Pages 963-966

  Raghuram, P ^a,c   Soma Raju, I V ^b,c   Sriramulu, J ^c  

^a HETERO LABS LTD   (India)

^b Invagen Pharmaceuticals Inc   (United States)

^c SRI KRISHNADEVARAYA UNIVERSITY   (India)

Author keywords

Amines; Gas chromatography; Head space injection

Indexed keywords

CANDESARTAN HEXETIL; CYCLOPROPYLAMINE; DIETHYLAMINE; DIMETICONE; OSELTAMIVIR; REAGENT; TRIETHYLAMINE; UNCLASSIFIED DRUG;

ACCURACY; ARTICLE; FLOW RATE; GAS CHROMATOGRAPHY; PRIORITY JOURNAL; PROCESS OPTIMIZATION; QUANTITATIVE ANALYSIS; SEPARATION TECHNIQUE; VALIDATION PROCESS;

EID: 77953023085     PISSN: 00095893     EISSN: 16121112     Source Type: Journal    
DOI: 10.1365/s10337-010-1530-0     Document Type: Article

References (26)

1. ICH (2007) Impurities: Guideline for Residual Solvents Q3C(R4) International conference on harmonization
2. United States Pharmacopeia (2009), USP31/NF26-General chapter < 467 > Residual Solvents
3. European Pharmacopeia. (2007) 6.0 Identification and control of residual solvents 2.4.24, Residual solvents 5.4
4. Center for Drug Evaluation and Research (CDER) (2009) Guidance on Residual solvents in the drug products marketed in the united states Food and Drug Administration
5. EDQM Europe (2007), Content of the dossier for chemical purity and microbial quality, PA/PH/CEP (04) 1 4R
6. DV Subbarao P Radhakrishnanand MV Suryanarayana V Himabindu 2007 J. Chromatographia 66 499 507 10.1365/s10337-007-0364-x (Pubitemid 47497685)
7. DV Subbarao P Radhakrishnanand V Himabindu 2008 J. Chromatographia 67 183 188 10.1365/s10337-007-0478-1
8. DV Subbarao KV Surendranath P Radhakrishnanand MV Suryanarayana P Raghuram 2008 J Chromatographia 68 829 835 10.1365/s10337-008-0766-4 1:CAS:528:DC%2BD1cXhtlSgsr7O
9. Hiroyuki Kataoka 2005 J Chromatogr Libr 70 364 404 1:CAS:528: DC%2BD1cXivFWrs74%3D
10. M Dalene G Skarping 1985 J Chromatogr A 331 321 330 10.1016/0021-9673(85) 80038-8 1:CAS:528:DyaL2MXls1Ggur8%3D
11. H Kataoka S Shindoh M Makita 1995 J Chromatogr A 695 142 148 10.1016/0021-9673(94)01271-F 1:CAS:528:DyaK2MXksVyqtbg%3D
12. HAH Billiet 1992 J Chromatogr Libr 51 B583 B595 10.1016/S0301-4770(08) 61518-3
13. F Sacher S Lenz H-J Brauch 1997 J Chromatogr A 764 85 93 10.1016/S0021-9673(96)00868-0 1:CAS:528:DyaK2sXjtlGqt78%3D (Pubitemid 27132879)
14. J Namieśnik B Zygmunt 2005 J Chromatogr Libr 70 340 363
15. H Kataoka 1996 J Chromatogr A 733 19 34 10.1016/0021-9673(95)00726-1 1:CAS:528:DyaK28XjtFegsb0%3D (Pubitemid 26166537)
16. C Maris A Laplanche J Morvan M Bloquelnal 1999 J Chromatogr A 846 331 339 10.1016/S0021-9673(99)00403-3 1:CAS:528:DyaK1MXkt1Gisr4%3D (Pubitemid 29332657)
17. http://www.cdc.gov/niosh/ipcsneng/neng0444
18. http://www.cdc.gov/niosh/rtecs/gza75bc.html
19. ICH (2007) Q3A(R2): Impurities in New Drug Substances Guidance
20. ICH (2007) Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance
21. United States Pharmacopeia (2009), 31 NF 26:General chapter < 1225 > Validation of compendial procedures
22. Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) (2000), Analytical Procedures and Methods Validation Chemistry, Manufacturing, and Controls Documentation, Draft Guidance U.S. Food and Drug Administration
23. EURACHEM, The Fitness for Purpose of Analytical Methods-A Laboratory Guide to Method Validation and Related Topics Guidance
24. Center for Drug Evaluation and Research (CDER) (1994),Reviewer Guidance Validation of Chromatographic Methods
25. EDQM (2005) Validation of Analytical Procedures PA/PH/OMCL (05) 47 DEF, OMCL (Office of medicinal Control Laboratories) Network
26. ORA LABORATORY PROCEDURE (2009) Methods, Method Verification and Validation-Food and Drug Administration-Document No.: ORA-LAB.5.4.5