National Collaborative Study to Establish the 1st National Standards of Heparin Molecular Weight Calibrant and Heparin for System Suitability of Molecular Weight Determinations / 中国药学杂志

ABSTRACT

OBJECTIVE: Molecular weight determinations of heparin sodium and heparin calcium were added in Chinese Pharmacopoeia (2015).To establish the 1st national standards of heparin molecular weight calibrant and heparin for system suitability of molecular weight determinations were needed to establish. METHODS: An national collaborative study involving twelve laboratories had taken place, organized by National Institutes for Food and Drug Control(NIFDC)to provide supporting data for the establishment of the 1st batches of heparin molecular weight calibrant and heparin for system suitability of molecular weight determinations standard. The method of heparin molecular weight determinations in Chinese Pharmacopoeia (2015) was used in the national collaborative study. The USP heparin sodium molecular weight calibrant RS (F0L483) was used as molecular weight calibrant. The USP heparin sodium identification RS(G1L413) was used as the standard of system suitability. The candidate national standards of heparin molecular weight calibrant (140819-201501) and the candidate heparin for system suitability of molecular weight determination standard(140818-201501) were tested in the study. RESULTS: To be calculated the cumulative percent of peak area at the 20 molecular points from 5 000-42 000 of the candidate national standard of heparin molecular weight calibrant (140819-201501). Based on the statistical analysis, the candidate gave low intra-and inter-laboratories variations. In laboratories, standard deviations (SD) of two laboratories ranged from 1% to 2%,others were less than 1%.Between laboratories, SD were all less than 1%,relative standard deviation(RSD) was all less than 10%. The intra-lab SD of the test to determine the molecular weight of the candidate heparin for system suitability of molecular weight determinations standard(140818-201501) was less than 180,except Lab 2. The inter-lab SD was 180. The RSD was 1.1%. CONCLUSION: After the examination of the expert committee on pharmaceutical standardization, the candidate (140819-201501) is approved as the first national standard of heparin molecular weight calibrant, provides the broad standard table. The candidate(140818-201501) is approved as the first national standard of heparin for system suitability of molecular weight determinations, with an assigned molecular weight (Mw) of 16 200. The two national standards can be used in the test of heparin molecular weight determinations in Chinese Pharmacopeia(2015).