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 Sponge 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%.

Digestibility— Place a 50-mg piece in a beaker of water.Knead gently between the fingers until thoroughly wet,and until all the air has been removed,taking care not to break the tissue.Lift from the water,and remove the excess water with absorbent paper.Place the wetted sample in a 150-mLflask that contains 100mLof a 1in 100solution of pepsin in 0.1Nhydrochloric acid previously warmed to 37.Maintain at a temperature of 37,and agitate gently and continuously until digestion is complete:the average digestion time of three determinations is not more than 75minutes.

Water absorption— Cut a portion of about 10mg from 1Absorbable Gelatin Sponge,weigh accurately,and place in a beaker of water.Knead gently between the fingers until thoroughly wet,and until all air has been removed,taking care not to break the tissue.Lift the portion of sponge from the water,and blot twice by pressing firmly between two pieces of absorbent paper.Drop the expressed sponge into a tared weighing bottle containing about 20mLof water,and allow to stand for 2minutes.Lift the sponge from the water with a suitable hooked instrument,allow to drain over the weighing bottle for 5seconds,and discard the sponge.Again weigh the weighing bottle and water:the loss in weight represents the weight of water absorbed by the sponge.Absorbable Gelatin Sponge absorbs not less than 35times its weight of water.

Expert Committee:(GTB)General Toxicology and Biocompatibility

USP28–NF23Page 892

Phone Number:1-301-816-8339