Establishment of the First National Reference Standard for Insulin Lispro: Report of a collaborative study
| Autor: | Meena Kumari, Matthew W. Borer, Renu Jain, Gaurav Pratap Singh Jadaun, Charu Mehra Kamal, Parveen Jain, Gurminder Bindra, Shruti Dixit, Vandana Saklani, Kim B. Dancheck, Surinder P. Singh, Zafar Abbas |
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| Rok vydání: | 2018 |
| Předmět: |
Pharmacology
medicine.medical_specialty Insulin Lispro General Immunology and Microbiology Computer science India Bioengineering General Medicine Reference Standards Applied Microbiology and Biotechnology Vial Europe Hplc assay medicine Insulin lispro Humans Medical physics Reference standards Biotechnology medicine.drug |
| Zdroj: | Biologicals : journal of the International Association of Biological Standardization. 58 |
| ISSN: | 1095-8320 |
| Popis: | The 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. |
| Databáze: | OpenAIRE |
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