Analytical Testing
Analytical testing terminology for procurement teams
Chromatography, spectroscopy and titration results are only interpretable with their methods and limits. This article defines the terms that appear on a Certificate of Analysis.
Evidence framework
Quality & Documentation
Product and corporate documents are reviewed for identity, scope, dates, issuer and publication suitability before anything appears publicly.
Product specifications
A specification defines the applicable tests and acceptance criteria for a clearly identified material, grade and version. Without an identified version it cannot be relied on.
Certificates of Analysis
A COA is batch-specific evidence. Review identity, batch traceability, methods, results, dates and authorisation rather than visual presentation. No analytical results are published here unless they come from a genuine reviewed document.
Safety Data Sheets
An SDS communicates hazard, handling, storage and transport information for a specified material and revision. It is not a quality certificate and does not confirm purity.
Verification status
Every document record is verified, pending verification, expired, associated with another entity, reference-only, or explicitly blocked from publication. Only verified records are eligible to publish.
Documentation guides
Product Specifications
Understanding pharmaceutical ingredient specifications
A specification is a contract about quality: the list of tests, the analytical methods, and the acceptance criteria a material must meet. This article explains how to read one and what is commonly missing.
Quality & Testing
Evaluating pharmaceutical ingredient documentation
Documents are the only evidence a remote buyer has. This article explains how to review a documentation package for internal consistency, traceability and authority.
Quality & Testing
How to read a Certificate of Analysis
A practical framework for checking identity, batch details, methods, results, and authorization.
SDS Education
How to read a Safety Data Sheet
A Safety Data Sheet governs safe handling, storage and transport. This article walks its sections and identifies the sections buyers most often skip.
Direct answers
- What documentation should accompany a tirzepatide batch?
- A batch Certificate of Analysis naming the batch and the specification applied, the analytical methods used, a Safety Data Sheet with the correct revision, and where applicable identity confirmation data. Documents that omit batch identity, method references, dates or an authorising signature cannot be treated as release evidence.
- Why is a purity percentage insufficient for a recombinant protein?
- Because protein quality is multidimensional. Beyond chromatographic purity, assessment covers primary and higher-order structure, charge and size variants, aggregation, host-cell protein and DNA residuals, biological potency expressed in international units, endotoxin and sterility. A single purity figure without the method and the acceptance criteria conveys very little.
- How are documents verified?
- Each record is checked for the named legal entity, issuer, number, dates, scope, verification source, status, and approval for public display.
Need material-specific information?
Guidance explains what to review. For a specific record, submit a technical enquiry so the request can be assessed.