The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 5: Disintegration Test General Chapter

Origin/Publisher:

FDA / ICH, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073427.pdf

Content:
This annex is the result of the Q4B process for Disintegration Test General Chapter.

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