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Printed on: Thu Jul 15 2021, 06:36:07 PM Official Status: Currently Official on 15-Jul-2021 DocId: 1_GUID-DB51A647-FFB9-4190-ADDD-63E901602538_1_en-US

(EST)
Printed by: Nguyen Nhan Official Date: Official Prior to 2013 Document Type: USP @2021 USPC
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if the package bears evidence of damage, or if the package has


Absorbable Gelatin Film been previously opened.
Sterility Tests á71ñ : meets the requirements.
» Absorbable Gelatin Film is Gelatin in the form of a Residue on ignition á281ñ : not more than 2.0%.
Proteolytic digest—Place 150 mg (±5 mg) in a
sterile, absorbable, water-insoluble film. glass-stoppered, 150-mL flask containing 100 mL of a 1 in 100
solution of pepsin in 0.1 N hydrochloric acid, previously
Packaging and storage—Preserve in a hermetically sealed warmed to 37°. Maintain at 37 ± 1°, and agitate gently every
or other suitable container in such manner that the sterility of 30 minutes until digestion is complete: the average time of
the product is maintained until the container is opened for use. three proteolytic digest determinations is between 4 and 8
Labeling—The package bears a statement to the effect that hours.
the sterility of Absorbable Gelatin Film cannot be guaranteed

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