Acceptance Limits for the New ICH USP 29 Content-Uniformity Test - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Acceptance Limits for the New ICH USP 29 Content-Uniformity Test
Revisions to the United States Pharmacopeia's (USP) uniformity test require manufacturers to establish new acceptance limits. The authors present their method for calculating acceptance limits consistent with USP's revised content-uniformity test requirements.

Pharmaceutical Technology

Where k = 2.4 for n = 10; k = 2.0 for n = 30; s is the standard deviation of the observations.

Unless otherwise specified, all the measurements of dosage units and criteria values (such as L 1) are in percentage label claim.

Lower probability bound of passing USP

Notice that P(passing USP test)

Assume that the X i 's follow a normal distribution denoted N (μ, σ). Then the values of P(S 1) and P(S 2) can be calculated as described in the following two subsections.

Computation of P(S 1)

Given the definition of AV, it can be seen that:

For T ≤ 101.5

The density function of Z 2 is a x2 distribution with n – 1 degrees of freedom and is denoted as x2 (n – 1).

The joint density function is f(z 1,Z 2) = f 1(z 1) f 2(Z 2),

Given the independence of z 1 and Z 2, P(S 1) can be rewritten in terms of z 1 and Z 2 as:

Computation of P(S 2)

There are two subcriteria in S 2, which are denoted as C 21 and C 22, respectively, as follows:

C 21 = AV of the 30 dosage units is less than or equal to L 1.

C 22 = no unit deviates from the calculated value of M by more than 25% of M.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Source: Pharmaceutical Technology,
Click here