As To The Related Requirements In YY/T 0308 “Medical Sodium Hyaluronate Gel” For Shear Viscosity, Intrinsic Viscosity Number, Weight Average Molecular Weight And Moleeular Weight Distribution Coefficient How Should Cross-linked Sodium Hyaluronate Gel For Injection Products Refer To Such Requirements?
2022-11-29
The administrative counterpart should analyze the applicability of the requirements for shear viscosity, intrinsic viscosity number, weight average molecular weight, and molecular weight distribution coefficient in YY/T 0308 to the product under application. When the relevant requirement is not applicable to the product under application or may not be measured in the final product, the quality control data on the relevant properties of the intermediate product without cross-linking treatment should be provided in the product research data.
