Packaging and storage— Preserve in a hermetically sealed or other suitable container in such manner that the sterility of the product is maintained until the container is opened for use.

Labeling— The package bears a statement to the effect that the sterility of Absorbable Gelatin Film cannot be guaranteed if the package bears evidence of damage, or if the package has been previously opened.

Sterility 71: meets the requirements.

Residue on ignition 281: not more than 2.0%.

Proteolytic digest— Place 150 mg (±5 mg) in a glass-stoppered, 150-mL flask containing 100 mL of a 1 in 100 solution of pepsin in 0.1 N hydrochloric acid, previously warmed to 37. Maintain at 37 ± 1, and agitate gently every 30 minutes until digestion is complete: the average time of three proteolytic digest determinations is between 4 and 8 hours.

Residual solvents 467: meets the requirements.

Expert Committee : (GTMDB05) General Toxicology and Medical Device Biocompatibility

USP29–NF24 Page 989

Phone Number : 1-301-816-8339