Doverin Labs
Analytical testing for peptide products
Certificate of Analysis
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| Client | — | Sample received | — |
|---|---|---|---|
| Accession no. | — | Lot no. | — |
| Product | — | Quantity per vial | — |
| Product no. | — | Date of manufacture | — |
| CAS no. | — | Retest date | — |
| Molecular formula | — | Date of issue | — |
| Molecular weight | — | ||
| Sequence | — | ||
| Test | Method | Specification | Result | |
|---|---|---|---|---|
| Appearance | Visual | White to off-white lyophilised powder | — | — |
| Solubility | QC-SOP-004 | Soluble in sterile water | — | — |
| Identity | ESI-MS · QC-SOP-011 | — Da (theoretical) | — | — |
| Purity | RP-HPLC-UV · QC-SOP-002 | ≥ 98.0% (area %) at 214 nm | — | — |
| Water content | Karl Fischer · QC-SOP-007 | ≤ 8.0 % | — | — |
| Residual TFA | RP-HPLC · QC-SOP-009 | Report result | — | — |
| Net peptide content | AAA · QC-SOP-012 | Report result | — | — |
| Net content | Gravimetric · QC-SOP-013 | Report result | — | — |
| Amino acid ratio | AAA · QC-SOP-012 | Conforms to sequence | — | — |
| Acetate content | RP-HPLC · QC-SOP-009 | Report result | — | — |
| Residual DMSO | GC-HS · QC-SOP-014 | ≤ 5000 ppm | — | — |
| Residual acetonitrile | GC-HS · QC-SOP-014 | ≤ 410 ppm | — | — |
| Residual methanol | GC-HS · QC-SOP-014 | ≤ 3000 ppm | — | — |
| Residual ethanol | GC-HS · QC-SOP-014 | ≤ 5000 ppm | — | — |
| Bacterial endotoxins | LAL · QC-SOP-021 | ≤ 10 EU/mg | — | — |
| Microbial limits | Ph. Eur. 2.6.12 · QC-SOP-022 | TAMC ≤ 1000 cfu/g · TYMC ≤ 100 cfu/g | — | — |
Storage—
Conclusion
The batch identified above conforms to the specifications listed. Analysis performed at Doverin Labs, Cambridge, United Kingdom.
Analysed by
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Date: —
Approved by
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Date: —