Blend uniformity acceptance criteria

TEMPLATES & PRESENTATIONS
1

Blend uniformity acceptance criteria

  1. Mean of individual values between 90.0-110.0 % of the label claim & RSD ≤5.0%.

  2. RSD ≤ 5.0% & all individual values are within ± 10 % of mean (absolute).

  3. Individual units are between 85-115% of label claim & RSD ≤ 6.0% - Obsolete.

Which of above three acceptance criteria is valid as on today?
Is there any guideline for BU. USFDA is having guideline which is at draft condition.

Can anybody provide comparative CU, BU & dissolution requirement of various regulatory authority i.e. EU, US, Japan, CA etc.

Thanks & Regards

2

Dear Samargadam,

In industry, they had assigned the BU acceptance limit based on the FDA draft guidance on “Powder Blends and Finished Dosage Units — Stratified In-Process Dosage”. The acceptance limit for BU is:

RSD (relative standard deviation) of all individual results ≤ 5.0 percent.
All individual results are within 10.0 percent (absolute) of the mean of the results.

Thanks & Regards,

C. Suresh