Analytical, Characterization and Stability Studies of Chemicals, Bulk Drugs and Drug Formulations

reportActive / Technical Report | Accession Number: ADB233658 | Open PDF

Abstract:

The overall purpose of this contract was to perform chemicalphysical analyses on bulk pharmaceutical substances and formulated drug products of interest to the USAMRMC Drug Development Program for parasitic and infectious diseases, chemical and biological defense, etc. Specific objectives were to design, develop, validate, and apply methods to determine chemical and physical characteristics on bulk drug and drug products. For the entire contract period, 1 August 1991 to 30 June 1997, 125 samples of bulk drugs and dosage formulations were analyzed for identity, purity or potency 133 samples were studied for stability and solubility. Four chiral separation methods were developed and validated, and 11 other chemical assay methods were validated. Special projects included the development and application of assays for determining protein content, residual solvents, and other relevant components in microsphere vaccine preparations. A second special project was the development and application of an assay for determining bischloromethyl ether in HI-6 bulk drugs. Posters were presented in the 1993 and 1996 Medical Defense Bioscience Reviews. One publication appeared in press and a second has been accepted for publication.

Author(s):
Lim, Peter
Author Organization(s):
SRI INTERNATIONAL MENLO PARK CA
Descriptive Note:
Final rept. 1 Aug 91-30 Jun 97
Supplementary Note:
DOI: 10.21236/ADB233658
Pagination:
0018

Security Markings

DOCUMENT & CONTEXTUAL SUMMARY

Distribution:
Approved For Public Release
Distribution Statement:
Approved For Public Release; Distribution Unlimited

RECORD

Collection: TR
Identifying Numbers
Contract/Grant Number(s):
DAMD17-91-C-1135
Monitor Series:
USAMRMC
 Subject Terms
Joint Capability Areas:
JCA_5_Command and Control; JCA_5.3_Planning; JCA_5.3.3_Develop Strategy; JCA_5.3.4_Develop Courses of Action; JCA_5.3.5_Analyze Courses of Action; JCA_4.5.4_Requirements Definition; JCA_4.5_Operational Contract Support; JCA_6.4.1_Secure Information Exchange; JCA_1.2.5_Lessons Learned; JCA_7.1.2_Prevent Non-kinetic Attack; JCA_7.1_Prevent; JCA_7_Protection
Communities of Interest:
No COI(s) Identified
Descriptor(s):
*CHEMICALS, *FORMULATIONS, *DRUGS, TEST AND EVALUATION, STABILITY, PHYSICAL PROPERTIES, PURITY, RESIDUALS, DOSAGE, SOLVENTS, DETERMINATION, POTENCY, PHARMACOLOGY, VACCINES, IDENTITIES, MICROSPHERES
Field(s)/Group(s):
Pharmacology
Keyword(s):
PHARMACEUTICAL SUBSTANCES, DRUG FORMULATION, BULK DRUGS
Report Date:
1997 Oct 01
Creation Date:
1998 Apr 01