467 RESIDUAL SOLVENTS - USP-NF
Sep 27, 2019 · produced in the manufacturing of drug substances, excipients, or dietary ingredients, or in the preparation of drug products or dietary supplement products. Appropriate selection of the solvent for the synthesis of a drug substance or an excipient may enhance the yield or determine characteristics such as crystal form, purity, and solubility.
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www.uspnf.com4 General Notices USP 32 3.10.10. Applicability of Standards to Drug Products, Drugarticle.For general requirements relating to specific monograph Substances, and Excipients sections, see section 5, Monograph Components. The applicable USP or NF standard applies to any article mar-Because monographs may not provide standards for all relevant keted in the United States that (1) is …
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