
Our Analytical Services
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Method Development and Validation
Precision defined. We meticulously focus on Identification, Assay, Impurities, Moisture Content, and Dissolution, ensuring that every method is not just developed but rigorously validated, setting the stage for reliable results.
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Release Testing and Stability Studies
A testament to endurance. From stability indicating methods for drug substance and product to specialized studies like Photo Stability and Freeze-Thaw evaluations, we ensure that drugs remain efficacious and safe throughout their lifecycle.
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Raw Material Testing
Unwavering purity and identity. We scrutinize raw materials for Purity, Identity, and Quality, ensuring that the foundation of every product we touch meets the highest standards.
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Physicochemical Characterization
Beyond the visible. Whether it's Particle Size, Shape, or Surface Properties, we delve deep, offering a comprehensive view of both drug substances and products, guaranteeing insights into Composition, Purity, and Stability.
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Impurity Testing
Clarity amidst complexity. Our detailed focus spans from known to unknown impurities. With a vigilant eye on Genotoxic and Carcinogenic impurities, and specialized Nitrosamine testing, we ensure utmost safety and compliance.
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Reference Standard
The beacon of accuracy. We take on the Qualification and Management of Reference Standards, ensuring they remain the gold standard for all our analytical procedures.
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Extractable and Leachable Method Development and Validation
Ensuring purity at every stage. We assess finished products and manufacturing materials in strict compliance with USP <1663> <1664>, making certain that unintended compounds remain out of the equation.
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Key Instrumental Capabilities
Where technology meets expertise. Our arsenal includes HPLC/UPLC, Chiral HPLC, GC-FID, and more, ensuring precision, accuracy, and reliability in every analysis.
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Documentation Support
Transparency at its best. From supporting dossier filing to responding to regulatory queries, our documentation reflects our commitment to clarity, compliance, and collaboration.