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What The FDA Category 1 vs Category 2 Status Means Today Under the FDAs interim bulk substances framework for 503A compounding pharmacies: Category 1: Bulk Drug Substances under evaluation with sufficient supporting safety information
Science , 327:296300
[PMID: 18671159] PubMed record related to this compound for laboratory literature review
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Acceptance criteria: The solution is clear and colorless
It features high separation efficiency, high sensitivity, and good reproducibility, allowing accurate determination of the active ingredient content and related substances in the capsules
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