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Review Papers | Pharmacy | India | Volume 12 Issue 9, September 2023 | Popularity: 5.9 / 10
A Review on Varciance Component Analysis: Interpretation of Deviation in Blend Uniformity Sampling
Aparna Arora
Abstract: Blend uniformity analysis is performed to check the homogeneity or uniformity of a powder blend, which involves blending of active pharmaceutical ingredient and excipient. In Pharmaceutical industry, sampling process plays a major role. Pharmaceutical sampling is process of selecting a part of the pharmaceutical product (raw material, intermediate product, final product) from a whole for further analysis. It is also a regulatory requirement. Variations in a statistically based sampling plan can be identified using Variance Component Analysis, where deviations intra/within locations or inter/between location results are identified and if intra location variation is identified it is known as a sampling error, whereas, if inter location variation is identified, it indicates non-uniformity of the blend. Usually, the final composition of the dosage form is just as uniform as the powder mixture used to make it. When creating formulations and processes, it's crucial to establish reliable blending and transfer techniques since they stop post-blending segregation of the mixture and allow for the production of commodities with a tolerable level of compositional homogeneity. Variance component analysis is a valuable technique to identify the underlying causes of mix and content uniformity issues, particularly during formulation and process development. Thanks to the use of statistically based sample strategies and proper sampling procedures, the right data are collected to allow for efficient statistical analysis. The examination and mitigation of potential underlying causes may lead to process improvements.
Keywords: Variance component analysis, blend uniformity, content uniformity, sampling
Edition: Volume 12 Issue 9, September 2023
Pages: 1553 - 1558
DOI: https://www.doi.org/10.21275/SR23920220129
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