♦This chapter describes general procedures, definitions, and calculations of common parameters and generally applicable requirements for system suitability.

The new harmonized standard for <621> Chromatography has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 4 sign-off cover sheet. The chapter has been formally approved by the General Chapters–Chemical Analysis Expert Committee in accordance with the Rules and Procedures of the Council of Experts.

Specific requirements for chromatographic procedures for drug substances and dosage forms, including adsorbent and developing solvents, are given in the individual monographs.

Chromatographic separation techniques are multistage separation methods in which the components of a sample are distributed between two phases, of which one is stationary and …

Calculate the tapped density (g/mL) using the formula MF/100 where MF is the mass of powder in the measuring vessel. Record the average of three determinations using three different powder samples. The test conditions including tapping height …

United States Pharmacopeia (USP) General Chapter <621> allows method adjustments and transfers, making it easier for labs to modernize original USP methods. The revised version of USP <621>, which became effective in December 2022, has been updated to …

Chromatographic purity tests for drug raw materials are sometimes based on the determination of peaks due to impurities, expressed as a percentage of the area due to the drug peak. It is preferable, however, to compare impurity peaks to the chromatogram of a …

Thin-layer chromatography on ion-exchange layers can be used for the fractionation of polar compounds. Presumptive identification can be effected by observation of spots or zones of identical RF value and about equal magnitude obtained, respectively, with an unknown and a reference sample chromatographed on the same plate.

Specific requirements for chromatographic procedures for drug substances and dosage forms, including adsorbent and developing solvents, are given in the individual monographs.

2024年9月16日 · USP <621> is one of the most important and accessed USP general chapters for the pharmaceutical industry. The scale of USP <621> is evident when searching for “<621>” in the current United States Pharmacopeia–National Formulary ( USP–NF ) electronic edition, which yields 3,980 results.