Ensure Your Regulatory Submissions are Complete...
Test your ingredients for identity, strength, quality, and purity:
Compendial (pharmacopeial) testing on the materials used in the manufacturing of pharmaceuticals is a basic requirement for most regulatory submissions around the world. Established pharmacopeial monographs such as those from the US Pharmacopeia-National Formulary (USP/NF), the European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP), and the British Pharmacopoeia (BP) provide standardized methods and specifications for pharmaceutical raw materials and finished products. Triclinic Labs has extensive experience with API, excipient, intermediate, and finished product analysis. We utilize USP/NF, EP, JP, BP, AOAC and ACS compendial methods for raw material and final product testing. Triclinic Labs provides a certificate of analysis (C of A) and operates under cGMP guidelines. We are FDA inspected (2016) and registered, and DEA licensed (Schedules I-V).
Our cGMP and non-cGMP material testing services include:
Complete Compendial Limit and Physical Testing (USP, EP, BP, JP, FCC, ACS, Others)
- General Identification Tests (USP <191>)
- TLC Identification Test (USP <201>)
- Residual Solvent Testing (USP <467>)
- Melting Range or Temperature (USP <741>)
- Loss on Drying (USP <731>)
- Dissolution (USP <711>)
- Identification and quantification by chromatographic procedures (TLC, GC, HPLC, GC/MS, HPLC/MS/MS)
- HPLC, GC and IC Analyses (USP <621>)
- Spectrophotometric Analyses / Infrared absorption (FTIR, UV/VIS) (USP <197> F, K, M)
- Metals Analyses (AA, GFAA, ICP) Container Testing (USP <661> and <671>)
- Uniformity of Dosage (USP<905>)
- Karl Fisher Moisture Analyses (USP <921>)
- pH (USP <791>)
- Other Wet Chemical Analyses (e.g. Color, Bulk Density)
Applications for Compendial Testing:
- Raw material testing (USP/NF, EP, JP, BP, Other International Pharmacopeial Organizational Standards)
- Dissolution studies
- ICH Stability Studies (raw material and finished products)
Applications for Non-Compendial Testing:
- Method Validation and/or transfers
- Verification of Raw Material received
- Impurity and Contaminant identification (for additional info click here)
- Stability and Disintegration studies
- Problem Solving (e.g. variable lot dissolution, consistency)
Method Development, Validation, and Consultation
It is common for our customers to require alternative methods to established compendial procedures. We have not only the capacity to perform these alternative methods, but also provide method development and validation services. For validation guidelines we use ICH (International Conference on Harmonization), EP (European Pharmacopoeia) and USP (United States Pharmacopeia). These guidelines specify the typical analytical characteristics required for validation testing. Depending on the particular test method and purpose (assay, impurity, degradation product, limit test, etc.), validations may include accuracy, precision, specificity, detection limit, linearity, range and robustness.We are available to help you decide what the appropriate approaches are to meet your Compenidal and Non-Compendial testing objectives.
Compendial Testing Service Levels Available:
