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 á71ñ: meets the requirements.

Residue on ignition á281ñ: not more than 2.0%.

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

Expert Committee:(GTB)General Toxicology and Biocompatibility

USP28–NF23Page 892

Phone Number:1-301-816-8339