Certificates of analysis
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Peptara Labs publishes certificates of analysis on its certificates page. Here we set out what one reports and what each line does and does not mean. A certificate shows what one lot tested as; it does not show a product is safe or approved for use in people.
For the lot it covers, a certificate reports identity by LC-MS, purity by HPLC against a release criterion of not less than 95.0 percent, net peptide content, sterility, bacterial endotoxin, heavy metals and a fentanyl immunoassay screen.
Peptara Labs states that its batches are tested by Titreon Analytical, a separate laboratory, and that Janoshik, a second, separate laboratory, supplies bacterial endotoxin reports for some batches only. The laboratories are set out on the testing page.
An HPLC purity figure is a relative peak area for one lot. It is not the amount of material in the vial, and it is not identity.
LC-MS checks identity by mass: a mass that agrees is consistent with a compound, but a matching mass cannot by itself rule out another compound of the same mass.
A fentanyl immunoassay screen flags a target rather than confirming it. Read this way, a certificate is a record of what one lot tested as, which is why the gaps are set out on what is not published.
Peptara Labs states that its vials ship without a printed lot, so you match a vial to its certificate by order number rather than by a label on the vial. How we read and restate the published record, without running any tests ourselves, is on the method page.
For the lot it covers, a certificate reports identity by LC-MS, purity by HPLC against a release criterion of not less than 95.0 percent, net peptide content, sterility, bacterial endotoxin, heavy metals and a fentanyl immunoassay screen.
An HPLC purity figure is a relative peak area for one lot. It is not the amount of material in the vial and it is not identity. LC-MS checks identity by mass, and a matching mass is consistent with a compound but cannot by itself rule out another of the same mass.
Peptara Labs states that its vials ship without a printed lot, so you match a vial to its certificate by order number rather than by a label on the vial.