TPM Laboratories, Inc. provides the following services:
Analytical Research and Development Testing Services
We offer 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