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
- Monograph method execution with system suitability
- General chapter method verification per USP <1226>
- CoA, summary report, and raw data package
- Second-person review and audit support
Who This Service Is For
Compendial testing support for regulated pharmaceutical operations.
Pharmaceutical QA/QC
Quality assurance and quality control teams needing compendial data for release, stability programs, and ongoing process verification.
Contract Manufacturers
CMOs and CDMOs looking for independent testing for raw material qualification, in-process testing, and finished product release.
Regulatory Affairs
Regulatory teams preparing ANDA, NDA, or DMF submissions that require cGMP compendial data packages.
When to Use This Service
Common triggers for compendial testing support.
- Raw material identity and purity confirmation
- Finished product release testing
- Method verification per USP <1226>
- OOS or deviation investigation support
What You Receive
Documentation and data packages aligned with regulatory expectations.
Certificate of Analysis (CoA)
Formal CoA listing each test performed, acceptance criteria, and results suitable for batch records and regulatory filings.
Summary Report
Narrative summary of findings, methods referenced, and observations noted during testing.
Raw Data Package
Complete chromatograms, spectra, calculations, and analyst worksheets for full traceability.
5-7 Day Turnaround
Standard turnaround from sample receipt. Rush turnaround is available upon request.
What "Compendial" Means
USP-NF methods are legally recognized standards for pharmaceutical testing.
A compendial method is published in an official pharmacopeia recognized by law. In the United States, the official compendia are the United States Pharmacopeia (USP) and the National Formulary (NF), both recognized under the Federal Food, Drug, and Cosmetic (FD&C) Act.
Monographs define tests, procedures, and acceptance criteria for specific drug substances, excipients, and dosage forms. General chapters (numbered <1-999> for mandatory and <1000+> for informational) describe analytical techniques, apparatus, and system suitability requirements referenced by monographs.
When we perform compendial testing, we follow exact procedures and acceptance criteria published in the current USP-NF, ensuring results are legally defensible and regulatory compliant.
cGMP Documentation & Data Integrity
Compliance-first documentation and review workflows.
Controlled Data (21 CFR Part 11)
Electronic records and signatures comply with 21 CFR Part 11 requirements. Audit trails are maintained for all analytical data, ensuring ALCOA principles.
Second-Person Review
All analytical results undergo independent second-person review before release. Calculations, integrations, and system suitability are verified by a qualified reviewer.
Audit Support
We support audits with complete documentation packages, SOPs, training records, and equipment qualification files available for review.
Methods & Capabilities
Instrumentation and method expertise to support compendial requirements.
Our compendial testing capabilities span USP general chapter methods. Explore the instrumentation details and sample requirements on each capability page:
Ready to Start?
Tell us your monograph, material type, and timeline. We will confirm method fit and turnaround.