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Establishment of European calibration CRS batches 2 and 3 for low molecular weight heparin by an international collaborative study / 中国药学杂志
Chinese Pharmaceutical Journal ; (24): 1864-1869, 2014.
Article in Chinese | WPRIM | ID: wpr-860160
ABSTRACT

OBJECTIVE:

An international collaborative study involving fourteen laboratories has taken place, organized by the European Directorate on Quality of Medicines (EDQM) and National Institute for Biological Standards and Control(NIBSC) to provide supporting data for the establishment of replacement batches of calibration chemical reference substance (CRS) for low molecular weight heparin (LMWH).

METHODS:

The study was organized in two phases A prequalification (phase 1, performed in three laboratories in 2005) followed by an international collaboration study (phase 2). Our institute (National Institutes for Food and Drug Control, NIFDC) took part in the phase 2 study started in March 2006. The molecular mass parameters were determined for seven different LMWH samples using the current CRS (CRS1) and two batches of candidate replacement material (cCRS2 and cCRS3) with a defined number average molecular mass (Mn) of 3700 determined in phase 1.

RESULTS:

The calculated values of cCRS2 and cCRS3 were systematically different from the values calculated using CRS1 with its assigned Mn of 3700. Using the raw data supplied by other participants, the molecular mass parameters were recalculated using cCRS2 and cCRS3 with values for Mn of 3800 and 3900. The calculated values using these Mn values agreed more closely with those calculated using CRS1, supporting the fact that the candidates, though similar in view of the production processes, differed slightly from CRS1 in terms of molecular mass distribution.

CONCLUSION:

The establishment of cCRS2 and cCRS3 could be recommended with an assigned Mn value of 3 800 that is consistent with both the phase 1 results and the determination result of current CRS1.

Full text: Available Index: WPRIM (Western Pacific) Type of study: Prognostic study Language: Chinese Journal: Chinese Pharmaceutical Journal Year: 2014 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Type of study: Prognostic study Language: Chinese Journal: Chinese Pharmaceutical Journal Year: 2014 Type: Article