Analytical Disclaimer

Certa analytical services and the reports produced from them are provided for analytical and research purposes.

A Certa report is not:

• a medical diagnosis
• medical advice
• a pharmaceutical approval or authorisation
• a treatment or dosing recommendation
• prescribing guidance
• confirmation that a sample is suitable for human or animal use

Certa reports on what was measured in a submitted sample. What is done with that information is a decision for the party taking it.

A result on one sample does not establish the characteristics of:

• an entire production batch
• another vial, container or unit from the same batch
• another shipment
• future material from the same source or supplier
• material that has been stored, handled or transported differently

Two units from the same batch can differ. Filling, storage and transport all affect a material, and a measurement is a record of one sample at one point in time. Reading a single result as a statement about a batch is the most common way an analytical report is misused.

Every result must be read inside the scope of the method that produced it. Different methods answer different questions, and one does not stand in for another:

• Purity is not content. A chromatographic purity figure describes the proportion of the detected material that is the main component. It does not establish how much of that component is present in the container.
• Identity is not purity. Confirming that a compound is what it is declared to be says nothing about what else is in the sample, or in what proportion.
• Endotoxin analysis is not a sterility test. An endotoxin result quantifies bacterial endotoxin. It does not establish the absence of viable microorganisms.
• Sterility testing is not chemical characterisation. It addresses microbiological status, not identity, purity or content.
• Elemental impurity screening covers selected elements. It reports on the elements included in the screen and does not identify every possible contaminant.
• An untested parameter is not a passed parameter. A report is silent on anything outside the agreed scope.

Results are also bounded by detection and quantification thresholds and by measurement uncertainty. A result reported as below a threshold means the method did not detect the substance above that level — not that it is absent.

A Certa report is an analytical document. It is not:

• a product certification
• a regulatory approval or clearance
• an endorsement or recommendation of a product
• a guarantee of quality beyond the parameters tested

Presenting a report as evidence of approval, certification or general product quality misrepresents it.

Report verification confirms that a document corresponds to a report issued through the Certa reporting system, and whether it is still current.

It does not re-run the analysis, does not extend the analytical scope, and is not an endorsement of the manufacturer, supplier, brand, batch or product.

Certa does not authenticate what a supplier says about a material beyond what the agreed analysis actually tests.

A company, manufacturer, brand or product name may appear in a report because it was part of the sample information provided. Unless a relationship is expressly disclosed, its appearance does not imply endorsement, partnership, approval or any commercial relationship with Certa.

Anyone submitting material for analysis is responsible for compliance with the law that applies to its:

• possession
• packaging and labelling
• shipment, including carrier and postal rules
• import and export, including customs requirements
• handling, storage and use

Certa does not give legal advice on whether you may possess, ship or use a given material, and accepting a sample for analysis is not a statement that doing either is lawful for you.

The terms and conditions set out how requests are accepted and how samples are handled.