Preparation of Rimantadine Hydrochloride Purity Certified Reference Material

LI Fukai; WANG Min; ZHOU Jian; YANG Mengrui; WANG Tongtong; LI Liang

doi:10.12338/j.issn.2096-9015.2023.0317

Volume 67 Issue 10

Oct. 2023

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Article Navigation > Metrology Science and Technology > 2023 > 67(10): 37-45

LI Fukai, WANG Min, ZHOU Jian, YANG Mengrui, WANG Tongtong, LI Liang. Preparation of Rimantadine Hydrochloride Purity Certified Reference Material[J]. Metrology Science and Technology, 2023, 67(10): 37-45. doi: 10.12338/j.issn.2096-9015.2023.0317

Citation:

LI Fukai, WANG Min, ZHOU Jian, YANG Mengrui, WANG Tongtong, LI Liang. Preparation of Rimantadine Hydrochloride Purity Certified Reference Material[J]. Metrology Science and Technology, 2023, 67(10): 37-45. doi: 10.12338/j.issn.2096-9015.2023.0317

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Preparation of Rimantadine Hydrochloride Purity Certified Reference Material

doi: 10.12338/j.issn.2096-9015.2023.0317

Institute of Quality Standard and Testing Technology for Agro-products, Chinese Academy of Agricultural Sciences, Beijing 100081, China

Received Date: 2023-11-28
Accepted Date: 2023-12-04
Rev Recd Date: 2023-12-05

Available Online: 2023-12-14

Publish Date: 2023-10-18

Abstract

Abstract

The development of a rimantadine hydrochloride purity certified reference material (CRM) (GBW 10262) was carried out using two independent methods: the mass balance (MB) method and quantitative nuclear magnetic resonance (qNMR) spectroscopy. Critical aspects of the CRM development process, including homogeneity, stability, calibration, and uncertainty, were systematically investigated. The purity of rimantadine hydrochloride CRM, as determined by both methods, was found to be 99.7%±0.3% (k=2). The CRM demonstrated excellent homogeneity, maintaining long-term stability for 20 months, and short-term stability for seven days at 50°C. The study also involved a thorough assessment of uncertainty sources, including characterization, stability, and homogeneity. The rimantadine hydrochloride CRM will support activities such as instrument calibration, method validation, and quality and safety risk monitoring.
- metrology,
- rimantadine,
- homogeneity,
- purity,
- certified reference material,
- uncertainty evaluation,
- MB,
- qNMR

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References(30)

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