DOD A-A-0051775-1986 CLONIDINE HYDROCHLORIDE TABLETS USP《美国专利氯压定氢氯化物药片》.pdf

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1、-c5-5 A-A-O051775 (DM) 11 December 1986 INTERIM COMMERCIAL ITEM DESCRIPTION CLONIDINE HYDROCHLORIDE TABLETS, USP 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

2、Materiel, DPSC-RST, 2800 South 20th Street, Philadelphia, PA 19101, based upon currently available technical information. Salient Characteristics: Shall be Clonidine Hydrochloride Tablets, USP. Shall be in accordance with the requirements of the USP. For Strength 1, shall be tablets containing 0.1 m

3、g of Clonidine Hydrochloride per tablet, within the applicable assay limits for the tablets. For Strength 2, shall be tablets containing 0.2 mg of Clonidine Hydrochloride per tablet, within the applicable assay limits for the tablets. For Strength 3, shall be tablets containing 0.3 mg of Clonidine H

4、ydrochloride per tablet, within the applicable assay limits for the tablets. Materials used in the manufacture of the tablets shall be of the highest pharmaceutical grade. WorkmanshiE. The tablets shall be free from defects which detract from their appearance or impair their serviceability. Unit. Fo

5、r Size 1- Bottle (BT). One bottle containing 100 tablets, as specified, constitutes one unit. For Size 2- Bottle (ET). One bottie containing 1000 tablets, as specified, constitutes one unit. AMSC/NA FSC 6505 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. O F . THIS

6、 DOCUMENT CONTAINS 3 PAGES. Licensed by Information Handling ServicesI I J A-A-0051775 b5 SSTqFG 0028373 4 A-A-O051775 (DM) For Size 3- Package (PG). One package containing 100 individually sealed tablets (unit dose), as specified, constitutes one unit. Contractor certification. The contractor shall

7、 certify that the product offered meets the salient characteristics of this - description and conforms to the producers own drawings, specifications, standards, and .quality assurance practices. The Government reserves the right to require proof of such conformance prior to first delivery and therea

8、fter as may be otherwise provided for under the provisions of the contract. Regulatory requirements. Federal Food, Druq and Cosmetic Act. If. the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurdisdiction, the offeror/contractor shall

9、comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/s

10、uppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations. use recovered material in accordance with Public Law 94-580 to the maximum extent practical. Preservation, packaqinq, p ackinq, labeling, and markinq. Unless othe.rwise specified,

11、 preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or contents thereof under normal shipping conditions, handling, etc:, involving shipment from the supply source to receiving activity, plus reshipment from receiving activity, and shall conf

12、orm to applicable carriers rules and regulations. Intermediate and exterior package quantities and labeling and marking shall be as specified in the contract and/or order. Recovered materials. The offeror/contractor is encouraged to NOTE: The following National Stock Numbers are covered by this docu

13、ment: STRENGTH - SIZE NSN ITEM IDENTIFICATION I 6505-01-005-8425 CLONIDINE HYDROCHLORIDE 2 TABLETS, USP, 0.2 mg, 100s 2 1 Licensed by Information Handling Services- + A-A-0051775 65 W 7777774 0028372 b A-A-O051775 (DM) NSN - 6505-01-024-9879 6505-01-030-1647 6505-01-058-5727 6505-01-101-3729 6505-01

14、-134-8387 6505-01-134-8388 Ordering data package quant the contract ITEM IDENTIFICATION STRENGTH SIZE CLONIDINE HYDROCHLORIDE 2 TABLETS, USP, 0.2 mg, 1000s CLONIDINE HYDROCHLORIDE 1 TABLETS, USP, 0.1 mg, 100s CLONIDINE HYDROCHLORIDE 1 TABLETS, USP, 0.1 mg, 1000s CLONIDINE HYDROCHLORIDE 3 TABLETS, US

15、P, 0.3 mg, 100s CLONIDINE HYDROCHLORIDE 1 TABLETS, USP, 0.1 mg, 100s Individually Sealed, Unit Dose CLONIDINE HYDROCHLORIDE 2 TABLETS, USP, 0.2 mg, 100s Individually Sealed, Unit Dose 2 1 Expiration dating required, intermediate/exterior ities and labeling and marking must be specified in and/or order. MILITARY INTERESTS: PREPARING ACTIVITY: Custodians: DoD - MB Army - MD Navy - MS Air Force - 03 Agent: DLA-DM CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS PHS FDA-MPQAS PGC 06029 Project No. 6505-2360 3 Licensed by Information Handling Services