Establishment of a replacement batch for the Ph. Eur. Heparin low-molecular-mass for calibration CRS
Year: 2025
Type: article
Abstract: . Stocks of this reference preparation were running low. Therefore, a replacement batch was established by the European Directorate for the Quality of Medicines & HealthCare (EDQM) under the aegis of the Biological Standardisation Programme. Due to the complexity of preparation of a replacement starting material, a ready-to-use candidate refill material was procured. A confirmatory study of the fitness for use was carried out, which demonstrated that the material was suitable for the intended purpose. The candidate CRS was adopted by the Ph. Eur. Commission in April 2024 as Ph. Eur. Heparin Low-Molecular-Mass for calibration CRS batch 6. It is available from the EDQM under catalogue number H0190000.
Source: PubMed
Author: European Directorate for the Quality of Medicines & HealthCare
Institution: Conseil de L'Europe
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W4413970826