BRIEFING

 〈697〉 Container Content for Injections. This proposal is based on the version of the chapter official as of May 1, 2015. The United States Pharmacopeia is the coordinating pharmacopeia for the international harmonization of the compendial standards for this chapter, as part of the process of international harmonization of monographs and general analytical methods of the European, Japanese, and United States pharmacopeias. The following chapter, which represents the Revision 1, OFFICIAL INQUIRY STAGE 2 document to this chapter includes the following changes:

1. Single-Dose Containers:

   • Revise to not specify a container number that must be tested. The focus should be on individual decisions based on process variability and lowest possible fill volume.

   • Revise to allow any suitable syringe to be used.

   • Revise to allow the testing of extractable volume on a per-container basis for small-volume parenterals ≤2 mL.

   • Revise so that containers ≥10 mL can be tested as per labeling instructions.

2. Injections in Cartridges or Prefilled Syringes:

   • Revise to not specify a container number that must be tested. The focus should be on individual decisions based on process variability and lowest possible fill volume.

3. Large-Volume Intravenous Solutions:

   • Revise to not specify a container number that must be tested. The focus should be on individual decisions based on process variability and lowest possible fill volume.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (GCPD: D. Hunt)

 Correspondence Number—C318770