Establishment of the First National Reference Standard for Insulin Lispro: Report of a collaborative study

Publication date: Available online 11 January 2019Source: BiologicalsAuthor(s): Gurminder Bindra, Gaurav Pratap Singh Jadaun, Shruti Dixit, Vandana Saklani, Zafar Abbas, Parveen Jain, Kim B. Dancheck, Matthew W. Borer, Meena Kumari, Charu Mehra Kamal, Renu Jain, Surinder Singh, Participants of the StudyAbstractThe present study was aimed to establish the First National Reference Standard (NRS) for Insulin lispro to allow stakeholders including manufacturer's laboratories, drug testing laboratories, drug regulatory authorities and academic institutions to demonstrate accuracy of the test results and to enable comparison and validation of analytical methods. The candidate standard for Insulin lispro was evaluated in a collaborative study to assign the vial content in order to serve it as NRS to support the Indian Pharmacopoeia (IP) monograph. The candidate standard was calibrated against the Ph. Eur. Insulin lispro reference standard by each of six participant laboratories in India using HPLC assay method as per the requirements of IP monograph. The results indicate that the candidate standard has an average content of 5.79 mg per vial with purity of 99.87%. Based on the study results the candidate standard was judged suitable to serve as the first NRS for Insulin lispro.

Source: Biologicals - January 12, 2019 Category: Biology Source Type: research