建立首个印度药典特立帕肽参考标准的合作研究报告

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2024-03-12 DOI:10.1016/j.biologicals.2024.101755

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。

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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.

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.