Pharma Specialists

BUCU

Content Uniformity (CU) Criteria for Narrow Therapeutic Index (NTI) Drugs

Narrow Therapeutic Index (NTI) drugs require tighter control ove…

January 24, 2025

BUCU

Practical Solutions for Improving Blend Uniformity and Sampling

1. Sift the material thrice through a coarser mesh to ensure uni…

January 20, 2025

BUCU

Selection of a Suitable Process for Oral Dosage Forms Based on Content Uniformity

How Content Uniformity Influences the Selection of a Suitable ma…

January 18, 2025

BUCU

Data-Driven Sampling Plans for Uniformity of Dosage Dnits

In pharmaceutical quality assurance, achieving precise and consi…

January 10, 2025

BUCU

Statistical Approach for Inter-Location and Intra-Location Variations in Blend Uniformity

Statistical methods help quantify and evaluate inter-location an…

January 01, 2025

BUCU

Stratified Sampling and Odd-Even Sampling for Content Uniformity (CU)

Introduction Stratified sampling and odd-even sampling are syste…

January 01, 2025

BUCU

Guideline for Ensuring Content Uniformity During Initial Development Phase

1. Selection of Drug Substance 2. Choice of Excipients 3. Formul…

December 30, 2024

BUCU

Blend Uniformity Failure | Immediate Actions to be Taken

If the first set of samples fails BU testing, follow these steps…

December 29, 2024

BUCU

Blend Uniformity Passing but Content Uniformity Failing

If blend uniformity (BU) is passing but content uniformity (CU) …

December 28, 2024

BUCU

Relationship Between Blend Uniformity (BU) and Content Uniformity (CU)

1. Definitions: BU: Refers to the uniform distribution of the ac…

December 26, 2024

ASTM

Statistical Analysis of Content Uniformity (CU)

As per FDA CGMP (21 CFR.211.110) an in-process testing is requ…

November 25, 2021

BUCU

Blend Uniformity Analysis (BUA)

Blend Uniformity Analysis (BUA) involves quantitative determinat…

September 22, 2021