ABSTRACT
This article describes some recent improvements to simplify the test for heavy metals, avoiding loss of analytes and increasing sensitivity.
Subject(s)
Metals, Heavy/analysis , Pharmacopoeias as Topic/standardsABSTRACT
This report includes a brief review of the toxicology of hydrazine and the strategies used to set acceptance criteria. A preliminary examination of a number of approaches to determine hydrazine in pharmaceutical substances susceptible to its presence either as residue from the synthesis or from decomposition are described.
Subject(s)
Drug Contamination/prevention & control , Hydrazines/analysis , Pharmacopoeias as Topic , Technology, Pharmaceutical/methods , Animals , Chromatography, High Pressure Liquid , Chromatography, Ion Exchange , Chromatography, Thin Layer , Europe , Humans , Hydrazines/toxicity , No-Observed-Adverse-Effect Level , Pharmaceutical Preparations/chemistry , Pharmaceutical Preparations/standards , Pilot Projects , Quality Control , Reproducibility of Results , Toxicity TestsABSTRACT
A reversed-phase liquid chromatographic method has been developed for the detection and control of impurities of imipramine hydrochloride at a level of 0.2 microg/ml (corresponding to 0.02 per cent in the procedure described). This method is included in a proposed revision of the monograph (Pharmeuropa 18.4) and replaces the thin-layer chromatographic method currently employed.
Subject(s)
Antidepressive Agents, Tricyclic/analysis , Chromatography, High Pressure Liquid , Drug Contamination/prevention & control , Imipramine/analysis , Pharmacopoeias as Topic , Technology, Pharmaceutical/methods , Chromatography, Thin Layer , Europe , Pharmaceutical Preparations/standards , Quality Control , Reproducibility of ResultsABSTRACT
Collaborative studies were initiated by the European Directorate for the Quality of Medicines (EDQM) to assign potency values for candidate European Pharmacopoeia Chemical Reference Substances (Ph. Eur. CRSs) used for the microbiological assay of antibiotics. The candidates were assayed against their respective International Standard (IS), using the methods by diffusion or turbidimetry. Potencies were assigned to all the antibiotics concerned, which were adopted by the European Pharmacopoeia Commission.
Subject(s)
Anti-Bacterial Agents/analysis , Anti-Bacterial Agents/standards , Europe , International Cooperation , Microbiological Techniques/methods , Microbiological Techniques/standards , Pharmacopoeias as Topic/standards , Reference StandardsABSTRACT
In the European Pharmacopoeia, the monographs on somatropin, somatropin bulk solution and somatropin for injection prescribe a number of tests including "related substances", "dimer and related substances of higher molecular weight" and "isoform distribution" which are intended to control the levels of impurities in the substance. The aim of this study was to verify the robustness of a new method by capillary electrophoresis and to compare its performance with that of the existing test for "isoform distribution" by isoelectric focusing. It was demonstrated that the capillary electrophoresis method was superior to the method of isoelectric focusing. The interest of the CZE method consists in the resolution of related impurities that might be process specific and/or generated by the expression system.