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This specification dealt with identification of small volume containers of drugs intended to be diluted before parenteral administration.
Formerly under the jurisdiction of Committee D10 on Packaging, this specification was withdrawn in May 2014. This standard is being withdrawn without replacement due to its limited use by industry.
1.1 This specification deals with identification of small volume containers of drugs intended to be diluted before parenteral administration, as follows:
1.1.1 Container shape,
1.1.2 Labeling statements.
1.1.3 Vial closures and Flip-Off, type caps, and
1.1.4 Ampoule marking.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D996 Terminology of Packaging and Distribution Environments
D4267 Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers
D4775 Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)
D7298 Test Method for Measurement of Comparative Legibility by Means of Polarizing Filter Instrumentation
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ASTM D5022-07, Standard Specification for Identification of Vials and Ampoules Containing Concentrated Solutions of Drugs to be Diluted Before Use (Withdrawn 2014), ASTM International, West Conshohocken, PA, 2007, www.astm.orgBack to Top