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ANALYTICAL DEVELOPMENT |
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| Extensive Method Development and Validation Services | |||
 Formulation/preformulation |
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| Assay |
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| Related substances |
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| Dissolution (IR, MR, pellets, suspensions, semisolids, patches, intrinsic dissolution) |
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| Gap analysis |
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| Residual Solvents and Organic Volatile Impurities |
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| Extractables/leachables |
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| Chiral drugs |
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| Cleaning procedures |
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| Stability indicating assays |
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| Remedial validation |
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| Forced degradation studies |
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| In-vitro metabolism studies |
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| Characterization of reference standard and drug substances |
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| Process validation support |
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| Method transfer |
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| Formulation development support |
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| Comparative studies |
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| Counterfeit product evaluation |
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| Medical device analysis |
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| Hazardous substance isolation lab |
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| Vendor qualification |
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| Isolation and identification of impurities and Degradation Products |
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| Cleaning (development, validation, and testing for actives and detergent residues) |
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| Physiochemical container/container closure integrity testing |
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| Semi-preparative HPLC scale-up and collection (mg and gm quantities) |
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