Analytical Research and Development Services
Capabilities
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Analytical method development & validations
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Analytical method qualifications & Transfers
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Elemental impurities analysis
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ICH Stability Studies
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Nitrosamines & Genotoxicity impurities assessment
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Structural / Solid state characterization & elucidation
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Polymorph quantification
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Prep. HPLC/chiral Purification
Services
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Purity of enantiomers
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Identification of related substances & assay
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Mass directed purification
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Supercritical Fluid Chromatography (SFC)
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Method development for non-chromophoric compounds
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Fate and purge studies
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Genotoxic Impurity (GTI) studies
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Impurity isolation & characterization
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Assay, dissolution, content uniformity & impurities content studies
We offer the following CRO services individually, tailored to specific client needs
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Custom research solutions
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Advanced analytical instrumentation
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Purification techniques
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Characterization
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Specialized analytical methods
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Impurity profiling expertise
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ICH Stability studies
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Regulatory Support – IND filing to commercialization
