Impurity deficiencies in submissions are remarkably consistent. Subathra Ramamoorthy, Veranova, explains how to catch them before agency filing.
News|Articles|May 1, 2002
- Pharmaceutical Technology-05-02-2002
- Volume 26
- Issue 5
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
Author(s)Ranga Velagaleti, PhD
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.
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Expanding the Use of Child-Resistant Packagingover 24 years ago
Outsourcing Outlookover 24 years ago
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Related to this article
Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready analytical methods.
Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
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