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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.
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| ANDAs: Impurities in Drug Products |
| Internet: | http://www.fda.gov/cder/guidance/6423dftrev1.htm |
| Origin/Publisher: | FDA |
| Content: | This guidance provides recommendations on what chemistry, manufacturing and controls (CMC) information sponsors should include regarding the reporting, identification, and qualification of degradation products in drug products. |
| Status: | Draft |
| Document Type: | Guidance for Industry |
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