Articles by Ranga Velagaleti, PhD - Pharmaceutical Technology

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Articles by Ranga Velagaleti, PhD

Solutol HS15 as a Novel Excipient

The authors present an update to the Wyeth/BASF experience with the IPEC Novel Excipient Safety Evaluation Procedure.
Nov 2, 2010

The authors present an update to the Wyeth/BASF experience with the IPEC Novel Excipient Safety Evaluation Procedure.

Regulatory Update: The IPEC Novel Excipient Safety Evaluation Procedure

The authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.
Nov 2, 2009

The authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.

Photosensitivity of Internal Standard Valerophenone Used in USP Ibuprofen Bulk Drug and Tablet Assay and Its Effect on the Quantitation of Ibuprofen and Its Impurities

Aug 2, 2004

The results of forced degradation studies indicate the need for alternatives to valerophenone as an internal standard calibration for quantifying ibuprofen in bulk drug and tablet assay samples.

Forced Degradation of Ibuprofen in Bulk Drug and Tablets and Determination of Specificity, Selectivity, and the Stability-Indicating Nature of the USP Ibuprofen Assay Method

May 1, 2002

The authors subjected ibuprofen bulk drug and tablet assay preparations to various stresses to evaluate the selectivity and specificity of the drug substance and product samples.

Validation Changes to the USP Assay Method for Ibuprofen Tablets

Mar 1, 2002

This study investigated the effectiveness of the direct extraction of tablets and shaking time on the disintegration of tablets, solubilization, and recovery of ibuprofen from tablets of various formulations, strengths, and spiked placebo.

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