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305 international Journal of Pharmaceutical compounding v 1 no 4 | J | A | 2014 www.iJPc.com QuAlity control Part 1 of this 2-part article contains
54 Dissolution Technologies | AUGUST 2013 Updates on USP Activities Related to Dissolution, Disintegration, and Drug Release Margareth R. C. Marques and William Brown
Total Organic Carbon Analysis for Purified Water and Water for Injection Application Note TOC for Purified Water and WFI; 3-Apr-13 Sales/Support: 800-874-2004 · Main: 513-229-7000
Chinese Pharmacopeia 2015 New Milestone of Excipients Standards in China Jessica Zheng Chair, Industry Liaison Committee, IPEC China Regulatory Manager China, Merck
10/21/2011 2 Antimicrobial Efficacy Test USP <51>/ISO11930 • Designed to demonstrate the ability of a multidose product to withstand microbial challenge.
3 de 83 “La validación de un método analítico es el proceso por el cual se establece, mediante estudios de laboratorio, que las características de desempeño del método
Comparison of dissolution profile of extended-release oral dosage forms – Two one-sided equivalence test 369 dissolution test of extended-release dosage forms as a
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products Guidance for Industry . U.S. Department of Health and Human Services
September 2007 Volume 33 Number 9 577 The Joint Commission Journal on Quality and Patient Safety identified and exported to a worksheet format.
Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics CHEMISTRY, MANUFACTURING, AND CONTROLS DOCUMENTATION U.S. Department of Health and Human Services
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