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日期:2024-08-10
The online version of Analytical Profiles of Drug Substances and Excipients at ScienceDirect.com, the world's leading platform for high quality peer-reviewed full-text journals. ... Help Direct export Export file Format RIS (for EndNote, Reference Manager...
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日期:2024-08-11
Suby.T.Baby The description, characterization and quantitation of the identified and unidentified impurities present in new drug substances is known as impurity profile. A general scheme is set for the estimation of the impurity of bulk drug substances by...
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日期:2024-08-11
European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40 E-mail: mail@emea.eu.int http://www.emea.eu.int EMEA 2006 Reproduction and/or distribution of this document is ......
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日期:2024-08-09
Contains Nonbinding Recommendations Guidance for Industry1 Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or...
Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Pro
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日期:2024-08-12
International Conference on Harmonisation - Quality ... Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances [Federal Register: December 29, 2000 (Volume 65, Number 251)]...
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日期:2024-08-06
Study #2736 May 2011 $4800 281 Pages Excipients US Industry Study with Forecasts for 2015 & 2020 Page 2 Order now, click here! Click here to purchase online Table of Contents ExEcutivE Summary markEt EnvironmEnt General Calcium ......
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日期:2024-08-06
Specifications should be set for identified and unidentified impurities expected to be present in the drug substances and drug products over the period of intended use and under recommended storage conditions. These impurities are known as specified impur...
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日期:2024-08-06
Transcript 1. Presentation compiled by “ Drug Regulations” a non-profit organization which provides an on-line resource to the Pharmaceutical Industry. Visit Drug Regulations for the latest information in Pharmaceutical Industry. 1...