Legal

Analytical Scope & Use

What our testing covers, what it does not establish, and how results should and should not be used.

A Certificate of Analysis from Analitika is a record of measurement. It describes what was found in the sample submitted, under the methods identified. It is not regulatory approval, product certification, or authorization to manufacture, sell, distribute, or administer any material.

What We Do

Analitika Compound Testing Inc. receives research-use materials submitted by clients, subjects them to validated analytical methods, and issues a Certificate of Analysis (COA) documenting the results. We test the sample you send us. That is the full scope of our service. We do not manufacture, supply, sell, distribute, import, export, package, label, or wholesale any compound or product. We do not determine whether a material is safe, effective, or suitable for any purpose. We do not provide medical, legal, or regulatory advice.

What a Certificate of Analysis Is

A Certificate of Analysis issued by Analitika describes: • The analytical results obtained from the specific sample submitted • The methods used to obtain those results • The date of testing and the conditions under which it was performed A COA is a record of measurement. It is not a product certification, a government licence, a market authorization, a quality guarantee, or an endorsement of the material or its intended use. It cannot be interpreted as permission to manufacture, sell, distribute, advertise, administer, prescribe, import, export, or possess any material. Payment, submission, a quote, a test request, or any automated system confirmation from Analitika does not constitute authorization to submit controlled, restricted, scheduled, or regulated materials. Clients with questions about whether a specific material can be accepted must contact us in writing before shipping.

Sample-Specific Results

Every result we issue describes the sample portion that was received and tested under the conditions identified in the report. Results cannot be assumed to apply to: • Any other vial, unit, batch, or lot — even from the same manufacturer • Any different preparation, concentration, or formulation • Any different time point or storage condition • Any material not physically submitted to our facility Analytical results describe what was measured. They do not establish the origin, history, chain of custody, or authenticity of the material prior to receipt.

Research Use Only

All testing services provided by Analitika are strictly for research-use and research-related purposes. Results issued under this scope must not be used to support claims of safety, efficacy, or fitness for human consumption, veterinary use, or any regulated application. Clients are solely responsible for ensuring that their activities — including the possession, transport, and use of submitted materials — comply with all applicable laws and regulations in their jurisdiction. Analitika accepts no responsibility for how results are used once delivered.

Methods and Limitations

Our primary analytical platform is reversed-phase HPLC with UV detection. This method measures chromatographic purity and, where requested, compound quantity against a reference standard. What HPLC purity measures: the relative proportion of the target peak in the chromatographic profile under the stated conditions. A high purity percentage reflects the chromatographic profile — it does not rule out the presence of isobaric compounds, isomers, or substances that co-elute under those conditions. Where identity confirmation is needed, orthogonal techniques such as LC-MS provide molecular mass evidence independent of retention behaviour. Endotoxin testing (LAL/BET) measures bacterial endotoxin activity per USP <85>. Heavy metals analysis (ICP-MS) measures elemental impurities against defined limits. Each method answers a specific analytical question — no single method answers all of them. Analitika is not ISO/IEC 17025 accredited. Testing is performed under documented internal SOPs, reference-standard controls, and internal quality controls. The methods applied to your sample are identified on the Certificate of Analysis.

Regulatory References

Where Analitika references USP, ICH, or other regulatory or scientific publications, those references identify the scientific or methodological context for the test performed. They do not imply that Analitika holds accreditation, registration, or authorization under those frameworks, nor that the tested material meets those standards or is approved for any regulated use.

Limitations on Liability

Analitika accepts no liability for any use made of a tested material, or for any decision made in reliance on analytical results. Our liability is limited to the analytical scope of the report and shall not exceed the amount paid for the specific test in question. Results are provided as analytical data only — any interpretation, application, or decision based on those results is the sole responsibility of the client. This page describes the scope of Analitika services. It is not legal, medical, or regulatory advice. Requirements depend on the material, intended activity, jurisdiction, and applicable law.

Questions

If you have questions about whether a sample is within our testing scope, or about the interpretation of a result, contact us before shipping. Contact us via the contact form on our website.

Before You Ship

Do not ship any suspected controlled, restricted, scheduled, or otherwise regulated material until Analitika has confirmed in writing that the material and requested testing can be lawfully accepted. A test request, quote, invoice, payment, or automated confirmation is not that authorization.