Gaurav Pratap Singh Jadaun , M. Kalaivani , Mukesh Kumar , Gyanendra Nath Singh , Rajeev Singh Raghuvanshi , Parveen Jain , Participants of the Study
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引用次数: 0
摘要
一项合作研究旨在建立首个特立帕肽印度药典标准物质（IPRS），用于对符合印度药典（IP）专著的上市产品进行质量控制检测。研究的目的是根据世界卫生组织国际标准（IS）对候选标准进行评估，以确定其含量（每瓶毫克）。这项研究涉及印度的四个实验室，每个参与研究的实验室都根据 IP 专著，采用高效液相色谱 (HPLC) 分析方法，对照世界卫生组织国际标准对候选标准进行了校准。候选标准物质的直接校准结果是每小瓶的指定含量为 1.02 毫克。根据研究结果，候选标准品被认为适合作为特立帕肽的首个 IPRS，通过 HPLC 进行鉴定和检测。
Report of a collaborative study to establish the first Indian Pharmacopoeia reference standard for teriparatide
A collaborative study was conducted to establish the first Indian Pharmacopoeia Reference Standard (IPRS) for teriparatide to be used in quality control testing of marketed products in compliance with the Indian Pharmacopoeia (IP) monograph. The study objective was to evaluate the candidate standard in terms of the WHO International Standard (IS) to assign its content in mg per vial terms. This study involved four laboratories from India and the candidate standard was calibrated against the WHO IS by each participant laboratory using high-performance liquid chromatography (HPLC) assay method per IP monograph. Direct calibration of the candidate standard resulted in an assigned content of 1.02 mg per vial. Based on the study results the candidate standard was judged suitable to serve as the first IPRS for teriparatide for identification and assay by HPLC.
期刊介绍：
Biologicals provides a modern and multidisciplinary international forum for news, debate, and original research on all aspects of biologicals used in human and veterinary medicine. The journal publishes original papers, reviews, and letters relevant to the development, production, quality control, and standardization of biological derived from both novel and established biotechnologies. Special issues are produced to reflect topics of particular international interest and concern.Three types of papers are welcome: original research reports, short papers, and review articles. The journal will also publish comments and letters to the editor, book reviews, meeting reports and information on regulatory issues.
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