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Is a batch COA available for the tesamorelin vial or pen?
An original, batch-specific certificate of analysis has not been supplied for either featured format. Tested purity, measured contents and contamination results therefore remain unverified on this website.
| Featured format | Stated contents | Available batch document |
|---|---|---|
| 10 mg powder vial | 10 mg, dry lyophilized powder | Original COA pending |
| 10 mg preloaded pen | 10 mg total in 3 mL; approximately 3.33 mg/mL | Original COA pending |
These are product label specifications, not measured results. Both featured formats are labeled for laboratory research.
Tesamorelin certificate of analysis
There is currently no COA PDF to download. Request the original report for the exact product and lot you are evaluating.
What should you check on a tesamorelin COA?
Start with traceability. FDA’s guidance for pharmaceutical ingredients describes certificates that identify the batch, tests, limits, numerical results and responsible issuer.1 Use these practical checks:
- Material and lot: Does the compound name match? Does the sample describe bulk powder, a filled vial or the finished pen? Match its batch number to the container.
- Issuer and dates: Look for the laboratory’s identity, report number, analysis date and authorized sign-off. Ask who submitted the sample.
- Methods and results: Each test should name its method and show a result, units and acceptance limit where applicable. A generic “passed” badge hides that detail.
- Authenticity: Request the complete original file. If needed, ask the named laboratory to confirm the report number through its own contact channel.
A report for another batch provides background, but does not establish the results for your container. “Third-party tested” needs an identifiable laboratory and matching report.
Does a high purity percentage prove there is 10 mg in the vial?
No. Identity, purity and quantity answer different questions. FDA’s analytical guidance separates identification, content measurement and impurity testing.2
| Result | What it addresses | What to ask |
|---|---|---|
| Identity | Whether the tested material matches the compound. | Which specific identification method was used? A chromatographic retention time alone is insufficient. |
| Chromatographic purity | The relative signal from the target and other detected components under that method. | Is this peak-area purity, and what impurities can the method detect? |
| Quantitative content | The measured amount or concentration. | Is there a calibrated assay result in mg per vial or mg/mL? |
HPLC can measure content when used as a quantitative assay against a suitable standard; a purity percentage alone is not that measurement. NIST-associated peptide research distinguishes calibrated HPLC assays from other quantitative methods, including amino acid analysis and quantitative NMR.3
Do purity tests also establish sterility or low endotoxin levels?
No. Look for separate results. A chemical purity result does not establish either of these:
- Sterility testing looks for viable microorganisms that can grow under the test conditions. It samples material at a particular time; it does not guarantee every container or continuing sterility throughout storage.4
- Bacterial endotoxin testing measures a different contamination concern. Check the method, units, result and applicable limit. An endotoxin result does not replace a sterility result.5
Also check which chemical contaminants were assessed, such as residual solvents, and which were outside the report’s scope. An unlisted test is unknown, not passed. None of these batch results is currently available for the featured products.
Can a powder COA verify a preloaded tesamorelin pen?
A powder report can describe the starting material if its lot is traceable to the pen. It cannot establish the finished liquid’s concentration, stability in its cartridge, or delivered volume.
Ask for evidence covering the final solution and container, supported storage conditions and shelf life, and device output testing. FDA’s injector guidance treats accuracy of delivered volume and agreement with device settings as specific performance questions.6 Container integrity is also a separate part of maintaining a sterile product through storage.4
The stated 10 mg in 3 mL gives a nominal concentration. It does not establish milligrams per click or demonstrate shelf life.
What else should you know before relying on a report?
Is a safety data sheet the same as a COA?
No. An SDS describes chemical hazards, handling, storage and emergency measures. It is not a batch’s analytical results and does not establish its purity, contents or sterility.7
Does the COA date tell me when the product expires?
The analysis date records testing. Check separately for a supported expiry or retest date and storage conditions; a recent report alone does not establish shelf life.1
What should I include in a documentation request?
Send the format, batch number and a clear label photo to [email protected]. Ask for the original laboratory report and, for the pen, documents covering the filled product.
Sources for interpreting quality documents
These sources explain analytical and documentation principles. They do not certify the featured products or establish their regulatory status.
- 1FDA / ICH Q7. Certificates, laboratory records and stability; sections 6.6 and 11.4–11.6.
- 2FDA / ICH Q6A. Identification, assay and impurity specifications.
- 3Li and colleagues, 2019; NIST publication record. Comparison of peptide quantification methods using oxytocin.
- 4FDA: Container and Closure System Integrity Testing. Sterility-test limitations and stability.
- 5FDA: Pyrogen and Endotoxins Testing, March 2026. Methods, sampling and acceptance criteria.
- 6FDA: Technical Considerations for Pen, Jet, and Related Injectors. Final-device performance and delivery accuracy.
- 7OSHA: Safety Data Sheets, Appendix D. Required SDS information.