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Synthesis and characterization of diclofenac impurity-A for the quality control of diclofenac and its formulation as per international compendiums

By: Wadhwa, Aparna.
Contributor(s): Verma, Sandhya.
Publisher: New Delhi CSIR 2019Edition: Vol.58(B), July.Description: 855-860p.Subject(s): GENERAL CHEMISTRYOnline resources: Click here In: Indian journal of chemistry (Section B)Summary: Diclofenac is one of the top selling non steroidal anti-inflammatory drug (NSAID). It is available in wide range of dosage form for symptomatic relief of diverse inflammatory conditions. Presence of impurity in drug or drug products is a vital concern now a days for which stringent regulatory guidelines have been implemented to safeguard public health. Under these circumstances, presence of diclofenac impurity-A in diclofenac requires strict quality control to satisfy the specified regulatory limit. Therefore, the objective of the presence study is to synthesize diclofenac impurity-A in the purest form and its subsequent characterization by using a panel of sophisticated analytical techniques to provide as reference standard mentioned in most of the international compendiums including Indian Pharmacopoeia.
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Diclofenac is one of the top selling non steroidal anti-inflammatory drug (NSAID). It is available in wide range of dosage form for symptomatic relief of diverse inflammatory conditions. Presence of impurity in drug or drug products is a vital concern now a days for which stringent regulatory guidelines have been implemented to safeguard public health. Under these circumstances, presence of diclofenac impurity-A in diclofenac requires strict quality control to satisfy the specified regulatory limit. Therefore, the objective of the presence study is to synthesize diclofenac impurity-A in the purest form and its subsequent characterization by using a panel of sophisticated analytical techniques to provide as reference standard mentioned in most of the international compendiums including Indian Pharmacopoeia.

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