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TPM Laboratories offers analytical method development and validation services in compliance with FDA and ICH guidelines. Method development and validation can be performed based on in-house or client supplied protocols. Forced degradation studies are performed during method validation and the degraded samples checked for peak purity using a Diode-Array Detector.
The method development and validation services include providing test methods and validation reports drafted to in-house requirements or client specifications. - Analytical Methods Development - Method Feasibility/Pre Validation Studies - Analytical Methods Validation - Analytical Methods Transfer The above services are provided for: - actives and inactives - impurities/degradation products/related compounds - OVIs/Residual Solvents Additional services include: - Impurity Profiling - Preformulation Studies - Drug Substance Evaluation
1165 Marlkress Road, Unit D
Cherry Hill, NJ 08003 US