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Analysis of active and inactive pharmaceutical ingredients, Chemical intermediates and finished products based on compendial methods of IP, BP Ph. Eur & USP Involved as contributor to monographs to IP, BP, USP and evaluation of IP reference standards. |
Analytical Method Development & Validation
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Development and validation of analytical methods (as per ICH guidelines).
- Estimation of organic volatile impurities.
- Impurity profiling of active pharmaceutical ingredients.
- Assay of active ingredients from finished dosage forms.
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Comparative Evaluation Of Pharmaceuticals/ Products
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Comprehensive & comparative physico-chemical evaluation of marketed brands. |
Cleaning Validation – Methods/ Protocol /Study Design
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Development & Validation of cleaning procedure.
Development of protocol for validation and execution of studies.
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OVI's & Investigational
Analysis Using |
GC/MS with head space analyzer LC–MS with auto analysis XRD crystallography.
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AAS Elemental Analysis Including Herbal Products
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For API, excipient, chemicals.
For Herbal products.
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Thermal Analytical Systems (TGA/DTA/DSC)
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For investigational analytical profiles and polymorphic evaluation. |