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API Raw material 99 Pharmaceutical Prednisone Powder

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    2019-1-1 · 1. Granulation Technology. Granulation technology is commonly used in the pharmaceutical industry during solid oral dosage form development, especially in tablet and capsule manufacturing (Parikh, 2010; Shanmugam, 2015).The process commonly is used for size enlargement, where small particles are produced by the addition of liquid to the powder mixture (excipient/API: active pharmaceutical ...

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  • Elucidating Raw Material Variability—Importance of

    INTRODUCTION. Variability in the functionality of powdered raw materials is an important quality issue for pharmaceutical dosage forms. Even though it is widely recognized that different physical characterization techniques provide complementary information, a robust definition of sameness with respect to functionality in pharmaceutical materials remains something of a challenge.

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    In this study, the impact of the raw material variability of an active pharmaceutical ingredient (API) in a high dose formulation on the twin-screw wet granulation process and on the resulting ...

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  • Excipient Variability and Its Impact on Dosage Form ...

    2015-3-1 · Effects and detection of raw material variability on the performance of near-infrared calibration models for pharmaceutical products J Pharm Sci , 103 ( 2 ) ( 2014 ) , pp. 545 - 556 Article Download PDF CrossRef View Record in Scopus Google Scholar

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    It is desirable for a pharmaceutical product to have more than one source for each raw material because of the constant supply requirements. Excipients obtained from different suppliers are often interchanged in the formulation. However, excipients of similar grade from different manufacturers often show variability in their properties.

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