DOI: 10.21276/ajptr
Mon, 25 Jun 2018

A Review on Impurities Profiling in Pharmaceutical Analysis

Durgesh Nandkishor Boob 1*, Santosh Dattu Navale 1, Manoj Mahale 1, Machindra Jayram Chavan1

1.Department of Quality assurance, Amrutvahini College of pharmacy, Sangamner- 422605, Maharashtra, India


ABSTRACT

In the pharmaceutical industry an impurity is considered, defined the any other organic material besides the drug substance or pharmaceutical ingredients.  The impurity may be formed during the formulation or upon aging of two APIs in medicines. The highly sophisticated instrumentation, such as mass spectra meters attached to the gas chromatography or HPLC in various matrices. GC is the most useful technique for identification of residual solvent. The advent of hyphenated technique has revolution any impurity profiling, by not only separation but structural identification of impurities as well among all techniques. The most exploited techniques for impurities profiling of drug are LC-MS-MS, LC-NMR, LC-NMR-MS, GC-MS AND LC-MS.

Keywords Impurity, Chromatography, Hyphenated technique, Regulatory bodies

 


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