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100 34.9 250 8 USP42 Carrier gas: Helium USP42 Flow rate: With the Standard solution, adjust the flow rate so that the retention time of the internal standard is about 10 min (about 4.3 mL/min). USP42 Injection volume: 1–2 µL Injection type: Spilt ratio, 40:1 Run time: 20.3 min System suitability Sample: Standard solution

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11/21/2016 33(2) Second Interim Revision Announcement: <1111> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: ACCEPTANCE CRITE…

2020年12月1日 · USP announces deferral of proposed 5.60.30 Elemental Impurities in General Notices.This proposed revision suggested a May 14, 2014 date linking General Chapters <232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures to drug product monographs in the United States Pharmacopeia (USP).

USP's revision of the standard for Bacterial Endotoxins has been approved by the Pharmacopeial Discussion Group (PDG) and will be incorporated with the second supplement within USP 35- NF 30.

Reimpresión de USP42-NF37 (oficial desde 1-Nov-2020) Este texto es una copia de cortesía del Capítulo General USP <1850> Evaluación de Tecnologías de Sondeo para Determinar la Calidad de Medicamentos, destinado únicamente para su uso como herramienta y recurso informativo. Consulte la edición

Stage 6 Harmonization Official August 1, 2015 〈616〉 Bulk Density and Tapped Density of Powders3 nations are desirable for the determination of this property.

USP42 Remove the plate from the chamber, mark the solvent front, and allow the solvent to evaporate. Locate the spots on the plate by examination under UV light. USP42 Acceptance criteria: Salicylaldazine appears as a fluorescent spot having an RF value of 0.3; and the fluorescence of any salicylaldazine spot from the