The Contractor shall provide analytical services for the analysis of bulk pharmaceutical substances and formulated drug products. Reports of analytical testing on bulk drugs and dosage forms will be used as a basis for assessing the suitability of these materials for use in screening, pharmacological studies, toxicological studies, formulation studies, or for clinical trials. These data will be supplied to the Food and Drug Administration (FDA) as part of the Investigational New Drug (IND) filings for new antitumor and anti- AIDS agents. Historical summaries of the data will be used in procurement actions as well as for the routine quality control of these materials. In addition, solubility and stability data will be developed, and selected assay methods will be adapted for the quantitation of drug in plasma. These data will be provided to other contract projects to facilitate formulation development, and to aid in the analytical aspects of pharmacology and toxicological testing.

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Treatment (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CM077104-004
Application #
2806795
Study Section
Project Start
1997-06-01
Project End
2002-05-31
Budget Start
1998-06-02
Budget End
1999-05-31
Support Year
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Sri International
Department
Type
DUNS #
City
Menlo Park
State
CA
Country
United States
Zip Code
94025
Cheung, Andrew; Struble, Elaine; He, Jingyi et al. (2005) Direct liquid chromatography determination of the reactive imine SJG-136 (NSC 694501). J Chromatogr B Analyt Technol Biomed Life Sci 822:10-20
Wang, E; Struble, E; Liu, P et al. (2002) A new sensitive HPLC assay for methoxyamine and its analogs. J Pharm Biomed Anal 30:415-27
He, J; Cheung, A P; Wang, E et al. (2001) High-performance liquid chromatographic analysis for a non-chromophore-containing phosphatidyl inositol analog, 1-((1-O-octadecyl-2-O-methyl-sn-glycero)phospho)-1D-3-deoxy-myo-inositol, using indirect UV detection. J Chromatogr A 913:355-63
Cheung, A P; Struble, E; Nguyen, N et al. (2001) Stability-indicating HPLC assay and solution stability of a new diaziridinyl benzoquinone. J Pharm Biomed Anal 24:957-66
Cheung, A P; Struble, E; Nguyen, N et al. (2000) Stability-indicating high-performance liquid chromatographic assay and analysis of decomposition products of 2-[4-[(7-chloro-2-quinoxalinyl)oxy]phenoxy]propanoic acid. J Chromatogr A 870:179-88
He, J; Cheung, A P; Struble, E et al. (2000) Enantiomeric separation of an aryloxyphenoxypropanoic acid by CE and LC. J Pharm Biomed Anal 22:583-95
He, J; Cheung, A P; Wang, E et al. (2000) Stability-indicating LC assay of and impurity identification in homoharringtonine samples. J Pharm Biomed Anal 22:541-54