Establishment of a replacement batch for the Ph. Eur. Heparin low-molecular-mass for calibration CRS.

Abstract

The European Pharmacopoeia (Ph. Eur.) prescribes that low-molecular-mass heparin products be calibrated for their molecular mass distribution using a reference preparation with a defined molecular mass calibration. Heparin low-molecular-mass for calibration Chemical Reference Substance (CRS) batch 5 was established to this end and is used in conjunction with a Broad Standard Table as described in monograph Heparins, low-molecular-mass (0828). 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.