Services & Equipment
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
General Testing Services
We offer testing of raw materials and finished products using a wide range of methods related to:
Compendial Testing (USP/NF/BP/EP/JP)
Quality Control Testing
Stability Testing and Retain Sample Services
- In-House Stability Storage Services according to ICH Guidelines
- Specialized Storage Services according to client specified conditions
- Stability Testing Services
- Stability Protocol and Report Preparation
- Stability Data Analysis and Specification Proposal
- Retain Sample Storage Services
- Annual Inspection of Retains
Special Testing and Auditing Services
- Process Validation Testing
- Cleaning Validation Methods Development, Validation and Testing
- Package Insert Compatibility Studies
- Personnel Monitoring and Air Sample Testing Services
- Pre Approval Inspection Services
- FDA Deficiency Response Preparation
- SOP Generation Services
- Laboratory Auditing
- Vendor Audit and Qualification
TPM Laboratories provides testing services using state of the art analytical instrumentation.
Our chemists have expertise and are well versed in the use of a wide range of instrumentation including:
- HPLC (Waters & Dionex – UV, PDA, RI, Fluorescence, Conductivity & ECD/PAD Detectors)
- Waters Fraction Collector III
- UHPLC (Waters H Class UPLC with PDA)
- GC & Headspace Analyzer (FID, TCD)
- Karl Fischer Titrator (Volumetric & Coulometric)
- pH meter
- Analytical and Micro Balance
- Refractometer
- Differential Scanning Calorimeter
- Dissolution System with Dissolution Sampler
- Disintegrator
- Friabilator
- Spectrophotometers (UV, IR)
- Polarimeter
- AA
- FIAS
- Osmometer
- Tap Densitometer
- Turbidimeter
- Viscometer
- Rotary Evaporator
- Stability Chambers
- Biological Safety Cabinet
- Conductivity Meter
- TOC
