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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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| Q3A Impurities in New Drug Substances, Revision 1 |
| Short Title: | Q3A(R) |
| Internet: | http://www.fda.gov/cder/guidance/4164fnl.pdf |
| Origin/Publisher: | Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857 |
| Content: | This guideline deals with impurities (organic, inorganic and residual solvents) in new active substances and defines limits as of which impurities must be identified or qualified. |
| Document Type: | Guideline for Industry |
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