USP-NF Compendial Testing
Pharmaceutical cGMP Testing With Official USP-NF Methods
Release and stability testing using monograph and general chapter methods, with documented data integrity and audit-ready reporting.
Compendial package includes
- USP-NF monograph execution with system suitability
- General chapter method verification per USP <1226>
- CoA, summary report, and raw data package
- Second-person review and audit support
Standards & Certifications
Who this is for
Teams that need clear analytical answers without extra intake friction.
Pharmaceutical QA/QC
Release, stability, raw material, and finished product testing under compendial expectations.
CMO and CDMO teams
Independent testing for raw material qualification, in-process checks, and product release.
Regulatory teams
Data packages for submissions that require cGMP compendial documentation.
What you receive
A concise testing package with the documentation needed to act on the result.
Certificate of Analysis
- Tests performed
- Acceptance criteria
- Results and conclusions
Summary report
- Method references
- System suitability context
- Observations and review notes
Raw data package
- Chromatograms or spectra
- Calculations
- Analyst worksheets and review trail
Compendial method details
USP-NF methods are legally recognized standards for pharmaceutical testing.
Monograph methods
Tests, procedures, and acceptance criteria for specific drug substances, excipients, and dosage forms.
General chapters
Analytical techniques, apparatus requirements, and system suitability criteria referenced by monographs.
Data integrity
Electronic records, audit trails, and second-person review aligned with cGMP expectations.
How We Work
From Request to Report in 3 Steps
Scope & Method Fit
We review your analytes, matrix, and specs to confirm the right method and timeline.
Run & Validate
Testing is executed with system suitability, QC checks, and documented traceability.
Report & Support
You receive a clean data package, summary, and follow-up support as needed.
Related capabilities
Technique pages for method fit, samples, and reporting expectations.
Ready to scope compendial testing?
Tell us your monograph, material type, and timeline. We will confirm method fit and turnaround.