Why do we check blend uniformity or what is the importance of blend uniformity…??
As a quality person how to ensure that your blend uniformity is ok ?
Uniformity of pharmaceutical products is most important thing…
When we want to blend two different batches, consider some quality aspects like assay, M.C/LOD, Purity, Related substances & Content of Residual solvents.
If both batches quality aspects are within the specifications, then we proceed for blending for optimum time by testing at different intervals to check the uniformity of the product…
Ex: During the blending collect the samples at different locations of blender as specified in blending validation protocol and tested them to check the uniformity of results…
If the testing results at two successive intervals are same then consider the initial time is suitable for blending…
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Please read the following link:
Importance of Blend Uniformity in Manufacturing Process : Pharmaguideline.
Blend uniformity is imp because if the speed and time of blending operation is inadequate that may impact the API mixing with extragranular material which may result in separation /segregation of material or over mixing may result in excecive coating of sized granule which may affect the DT of tablets. Eg.magnesium sterate .
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