A-A-0051934(DM)
10 April 1987
INTERIM COMMERCIAL ITEM DESCRIPTION
NITROGLYCERIN TRANSDERMAL SYSTEM, MICROSEALED
The General Services Administration has authorized the use of this Interim Commercial Item Description which was developed by the Defense Personnel Support Center, Directorate of Medical Materiel, DPSC-RST, 2800 South 20th Street, Philadelphia, PA 19101, based upon currently available technical information.
Salient Characteristics:
Shall be Nitroglycerin Transdermal System designed to deliver nitroglycerin at a controlled release rate into the blood stream via the skin by a microsealed (partition-controlled) drug delivery system.
Materials used in manufacture of the product shall be of pharmaceutical grade.
For Strength 1, the nitroglycerin transdermal system shall provide 5 mg of nitroglycerin per 24 hour period. Shall contain 16 mg of nitroglycerin within the applicable assay limits on a 8cm2 flexible, nonsensitizing adhesive bandage (patch).
For Strength 2, the nitroglycerin transdermal system shall provide 10 mg of nitroglycerin per 24 hour period. Shall contain 32 mg of nitroglycerin within the applicable assay limits on a 16cm2 flexible, nonsensitizing adhesive bandage (patch).
Shall comply with the Content Uniformity requirements in the USP for capsules.
Workmanship. The product shall be free from defects which detract from its appearance or impair its serviceability.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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