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solubility usp monograph

November 28, 2020

USP-NF English Edition; USP–NF Spanish Edition; USP–NF Archive Products ; USP–NF Mobile App; FAQs. The composition of a saturated solution, expressed as a proportion of a designated solute in a designated solvent, represents this thermodynamic limit of solubility. Pending Monographs; Purchase. Excipient monographs are in the NF. Index Review and search the combined USP and NF index. The information is provided monographs. Description and Relative Solubility of USP and NF Articles The “description” and “solubility” statements pertainingand other particulate matter, unless limited or excluded by to an article (formerly included in the individual mono- definite tests or other specifications in the individual graph) are general in nature. Anticipated implementation timing: Routine. Identification— A: Liquid Chromatographic Identification Test— Mobile phase— Prepare a mixture of 0.1 M tribasic sodium phosphate and acetonitrile (77:23), and adjust with phosphoric acid to a pH of 3.0. Monographs for dietary supplements and ingredients appear in a separate section of the USP. The new General Chapter is intended to provide additional tools for determination of degree of solubility of excipients and drug substances, and the establishment of bio-relevant solubility measurements for applications such as Biopharmaceutical Classification (BCS). This will be followed by a brief description of typical experimental methods used to assess solubility of pharmaceutical materials. B: It responds to the flame test for Potassium 191. //-->

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