T/SQIA 118-2025 Active Group standards

T/SQIA 118-2025 Dissolution curve comparison in-vitro for quality consistency evaluation of Oseltamivir Phosphate for Oral Suspension

Publish Date: 2025-08-28 Implement Date: 2025-09-08 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/SQIA 118-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Biological products and blood products

ICS Name: Comprehensive Pharmaceutical Science

Publish Date: 2025-08-28

Implement Date: 2025-09-08

Scope

This document specifies the requirements for the dissolution curve determination method for the consistency evaluation of generic Oseltamivir Phosphate Oral Dry Suspension, including the principle, reagents and materials, instruments and equipment, analytical steps, dissolution calculation, and methods for comparing and determining the similarity of the dissolution curve with the reference preparation. This document is applicable to evaluating the similarity of the drug release of generic Oseltamivir Phosphate Oral Dry Suspension with the reference preparation using the dissolution curve method. This document specifies the requirements for the dissolution curve determination method for the consistency evaluation of generic Oseltamivir Phosphate Oral Dry Suspension, including the principle, reagents and materials, instruments and equipment, analytical steps, dissolution calculation, and methods for comparing and determining the similarity of the dissolution curve with the reference preparation. This document is applicable to evaluating the similarity of the drug release of generic Oseltamivir Phosphate Oral Dry Suspension with the reference preparation using the dissolution curve method.