T/CSBM 0032-2023 Active Group standards

T/CSBM 0032-2023 Guidelines for the determination of residual organic solvent levels in allogenic products

Publish Date: 2023-04-24 Implement Date: 2023-10-01 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/CSBM 0032-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2023-04-24

Implement Date: 2023-10-01

Scope

Main Technical Content: 4. Preparation of Extract Solution 4.1 General Principles For the determination of organic solvent residues in allograft products, the preparation methods of extract solution typically include limit extraction, strict extraction, and simulated use extraction. Due to the advantages of simple operation, high extraction efficiency, and ease of testing, limit extraction is widely used in the preparation of extract solution for residual solvent determination. 4.2 Extraction Container The extraction container should be made of borosilicate glass with a ground-glass stopper or a screw cap with a sealing pad of inert materials (e.g., polytetrafluoroethylene). 4.3 Extraction Solvent If the solvent to be tested is easily soluble in water, water should be preferentially selected as the extraction solvent. If the solvent is difficult or insoluble in water, a solvent capable of dissolving it should be chosen, provided it does not dissolve the main material. The selected extraction solvent should not interfere with the determination of the solvent to be tested. 4.4 Extraction Ratio Unless otherwise specified, allograft bone materials, tendons, meniscus, and nerves are typically extracted at a ratio of 0.1 g–0.2 g of sample to 1 mL of extraction solvent. For thin-film products such as allograft dressings, dermis, patches, and amniotic membranes, the ratio is typically 0.5 cm2–6.0 cm2 of sample to 1 mL of extraction solvent. Before extraction, the samples should be cut into pieces no longer than 5 mm in length, and the extraction solvent must submerge the samples. 4.5 Other Extraction Conditions 4.5.1 Other extraction conditions include extraction time, temperature, and whether dynamic extraction (ultrasonication, shaking) is used. 4.5.2 When using headspace gas chromatography for determination, online extraction is typically selected. For water as the extraction solvent, the equilibrium temperature of the headspace vial is 60°C–85°C,