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.
Finding the right fit
Who this is for
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.
Your next step
What you receive
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
Planning your project
A scope that fits
your requirements.
Explore the details, or talk with us about your sample. We confirm methods, documentation, and timing before testing begins.
Review Quality StatusCompendial method details
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.
Timing and turnaround
Standard turnaround
5–10 business days for most analyses.
Expedited QC packages
As fast as 24 hours when method, matrix, and capacity allow.
Rush service
Quoted case-by-case, subject to method fit, sample receipt, and lab availability.
Illustrative testing scenarioChecking a compendial specification
An example of how to scope this service, not a client case study or a reported result.
The question
A quality team needs to evaluate a material against an applicable USP-NF monograph.
Testing approach
Confirm the monograph, sample matrix, required tests, and method suitability before accepting the scope.
What you receive
Results linked to the agreed compendial methods and acceptance criteria, with scoped cGMP documentation.
The decision it supports
The quality team can assess conformity and determine whether additional testing or investigation is needed.
The sample report illustrates reporting format; it is not a valid analytical report for this scenario.
Let’s discuss your sample
Ready to scope compendial testing?
Tell us your monograph, material type, and timeline. We will confirm method fit and turnaround.