Proposed new USP Chapter <1095> Batch Release Testing for Ensuring Compliance with Uniformity of Dosage Units

In the Pharmacopeial Forum, PF 47(4), a proposal of a new USP Chapter <1095> Batch Release Testing for Ensuring Compliance with Uniformity of Dosage Units, addressing the common use of Uniformity of Dosage Units <905> as a batch release test, has been published for comments.

A Chapter numbered below 1000 becomes applicable and compendially required respect were it is referenced in a monograph or another applicable General Chapter numbered below 1000 or in General Notices. General Chapters numbered 1000 to 1999 are for informational purposes only. They are considered interpretive and are intended to provide information on, give definition to, or describe a particular subject.

According to the USP, the new proposed "chapter presents an approach to testing for content uniformity that is focused on ensuring that an item in commerce will meet the requirements of <905> utilizing appropriate quality risk management principles."

The chapter is divided into the following sections:

  • Introduction
  • Basic Principles
  • Parametric Batch Release
  • References

The draft of the proposed new chapter <1095> Batch Release Testing for Ensuring Compliance with Uniformity of Dosage Units is available following this link. (Please note: a one-time registration is required to access the Pharmacopeial Forum.) The deadline for submitting comments is September 30, 2021.

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