01. Match the report to your vial
A certificate of analysis records analytical results associated with identified material. Before interpreting a percentage, check that the document belongs to the compound and lot on your label. [1]
- Match the compound name and LOT number exactly.
- Check the stated vial amount and any sample description.
- Identify the issuing laboratory, report or sample identifier, and dates.
- Read the complete report, including methods, results, units, limits and notes.
Report formats vary. ICH Q7 describes batch identification, dates, test results and acceptance limits for pharmaceutical API certificates; those fields are a useful reading checklist, not evidence that MGMT materials are GMP-certified or approved medicines. [3]
02. Identity, purity and measured content
| Result | What to read | Keep in mind |
|---|---|---|
| Identity | Does the analysis support the stated compound identity? | Check the identification method and reported conclusion. |
| Purity | What purity result did this method measure? | A percentage is method-dependent; it is not the milligrams in a vial. |
| Measured content | How much peptide was quantified, in the stated units? | Distinguish the measured result from the expected label amount. |
SideChain describes HPLC-MS/MS identification and calibrated quantification. Its report-reading information separates expected amount, measured amount, chromatographic purity where assessed, and recovery relative to the label claim. [2]
03. Read the method, units and limits
Bachem explains that HPLC purity measured by UV detection concerns the material detected under that method. Gross powder weight can also include water and counterions. A purity percentage, powder weight and peptide-content measurement therefore answer different questions. [1]
Do not assume that a UV-HPLC percentage and a targeted HPLC-MS/MS result use the same definition. Read the laboratory’s method and units; ask the issuer if “purity”, “content” or “recovery” is unclear.
A pass/fail label must be read against the stated acceptance criterion. This guide sets no universal purity threshold and does not convert analytical results into dosing instructions. [3]
04. Know what the report covers
Only tests actually listed in the report are documented. Identity, assay, impurities, sterility and endotoxins are distinct testing considerations in ICH Q6A. A purity result alone does not establish sterility or endotoxin status. [4]
SideChain offers additional heavy-metal and endotoxin testing. That availability does not mean those tests were performed on a particular MGMT batch; check its actual report. [2]
A report must remain tied to its identified sample and lot. Do not treat it as proof that every vial was individually tested, or as a guarantee after subsequent storage and handling.
05. Verify the original report
Use the issuing laboratory’s official website. SideChain’s verification page accepts a report number, sample ID or verification code; it also describes QR verification. Use identifiers from the actual issued document. [2]
Compare the retrieved record with your document and vial label. If the lot, amount, compound or results differ, ask MGMT and the issuing laboratory to clarify before relying on the report.
06. If your report is missing or different
Check MGMT’s Batch Reports page for the document corresponding to your lot. A pending report is not a completed result. Do not substitute a different lot, vial amount or a laboratory’s sample certificate.
07. Quick questions
Does a high purity percentage confirm the labelled milligrams?
No. Read the measured-content result and its units separately from the purity result.
Does “pending” mean a batch passed?
No. It means a completed report is not available in that listing.
Can one report be used for another lot?
Do not assume so. Match the lot and sample information, and ask for clarification if they differ.
08. Sources and scope
Laboratory descriptions explain the issuer’s methods; Bachem explains general peptide-analysis terms. ICH references provide pharmaceutical analytical context, not certification or approval of MGMT or its products.