Pharmaceutical Testing
Pharmaceutical cGMP Testing for Release and Stability
USP-NF compendial and monograph testing for drug substances, excipients, and finished products with documented data integrity.
Program Highlights
- Compendial testing for APIs, excipients, and products
- Method verification and system suitability
- CoA, summary reports, and raw data packages
- Second-person review and audit readiness
Standards & Certifications
Scope & Deliverables
Compendial testing coverage and documentation built for regulated programs.
Drug Substance (API) Testing
- Identity testing (IR, UV, HPLC)
- Assay / potency by USP monograph
- Related substances and impurities
- Residual solvents (USP <467>)
- Water content (Karl Fischer)
Excipient Testing
- USP-NF monograph compliance
- Identity and purity testing
- Heavy metals screening
- Microbial limits (USP <61>, <62>)
- Loss on drying / residue on ignition
Finished Product Testing
- Content uniformity (USP <905>)
- Dissolution testing (USP <711>)
- Assay and related substances
- Physical testing (hardness, friability, disintegration)
- Stability-indicating methods
What "Compendial" Means
USP-NF methods are legally recognized standards for pharmaceutical testing.
The United States Pharmacopeia–National Formulary (USP-NF) is the official compendium of drug standards in the United States. When testing is described as "compendial," it means the methods and acceptance criteria are defined by USP-NF monographs — legally enforceable standards recognized by the FDA.
USP General Chapters (numbered <1000) are mandatory when referenced in a monograph. These include critical test procedures such as <621> Chromatography, <731> Loss on Drying, <791> pH, and <467> Residual Solvents. Chapters numbered ≥1000 provide informational guidance.
Our laboratory performs testing per current USP-NF editions, ensuring your products meet the standards required for regulatory submissions, batch release, and quality control.
Quality & Compliance
Data integrity and review practices aligned with FDA expectations.
ALCOA Data Integrity
- Attributable — every entry traced to its source
- Legible — clear, permanent records
- Contemporaneous — recorded at the time of activity
- Original — primary data preserved
- Accurate — truthful, complete, and verifiable
cGMP Documentation
- FDA 21 CFR Part 211 compliance
- Complete batch records and audit trails
- Validated analytical methods
- Out-of-specification investigation procedures
- Change control and CAPA processes
Quality Systems
- Instrument qualification (IQ/OQ/PQ)
- NIST-traceable reference standards
- Analyst training and competency records
- Environmental monitoring
- Internal audit program
Ready to Start Your Pharmaceutical Testing?
Tell us the monograph and material type. We will confirm method fit and turnaround.