All Industries
Raw Materials & APIs Testing
Incoming material testing, identity confirmation, and certificate of analysis verification for active pharmaceutical ingredients, excipients, and raw materials.
Get StartedTesting Challenges
Key Analytical Challenges
Identity and purity verification of incoming materials
Certificate of Analysis (COA) verification testing
Supplier qualification and material screening
Residual solvent and impurity profiling
Specification development for novel materials
Regulatory Framework
Applicable Standards
USP/NF Monographs
USP <232>/<233>
USP <467>
ICH Q3D
21 CFR Part 211
ISO 17025
3–5 Days
Digital COAs
Available Testing
Services for Raw Materials & APIs
Identity Testing
HPLC, FTIR, and wet chemistry methods for raw material identity confirmation
Purity Analysis
Assay and related substances testing by HPLC/UPLC
Heavy Metals
ICP-MS elemental impurities screening per USP <232>/<233>
Residual Solvents
GC-MS headspace analysis for residual solvents per USP <467>
COA Verification
Independent testing to verify supplier-provided Certificates of Analysis
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