Lot / batch number
PL-2609-031
PrymaLab
PrymaLab Analytical · In-house laboratory
3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net
Certificate no.
PL-26-00031
Verification key
VGPQQ77C
Scan or enter both at
prymalab.net/testing/verify
prymalab.net/testing/verify
Certificate of Analysis · Lot release
EPO (Erythropoietin) 3,000 IU
Lot PL-2609-031 · Lyophilized powder · Label claim 3000 IU/vial (≈ 25 µg glycoprotein)
Tested in-house by PrymaLab
In-house analytical result,
not an independent third-party test
not an independent third-party test
Date made
2026-09-18
Date of analysis
2026-09-19
Date issued
2026-10-03
Retest / expiry
2028-09-18
Units in lot / sampled
250 / 2
Storage
2–8 °C, dark; do not freeze
Certificate type
Lot COA, 2 pages
Compound
Erythropoietin (rhEPO)
Recombinant human erythropoietin, epoetin class
CAS number
11096-26-7
Molecular formula
C809H1301N229O240S5 (165-residue protein core)
Theoretical mass (avg.)
About 30.4 kDa glycoform average; 18.2 kDa protein core
Structure
165-residue mature human EPO (UniProt P01588 residues 28–192; C-terminal Arg166 removed), CHO-expressed; N-glycans at Asn24, Asn38 and Asn83, O-glycan at Ser126; disulfides Cys7–Cys161 and Cys29–Cys33.
Purity · RP-HPLC, area %
99.18%
Specification 99.0% • main peak (glycoform cluster) at 7.18 min
Identity · Observed Mass
30,412 Da
Deconvoluted glycoform centroid • theoretical 30.4 kDa average
Overall conclusion
PASS
Meets every specification for the tests performed
| Test | Method | Specification | Result | Conclusion |
|---|---|---|---|---|
| Appearance | Visual inspection | White lyophilized powder or cake | White lyophilized cake | PASS |
| Identity (mass) | LC-MS, ESI positive | Within glycoform envelope | 30,412 Da centroid (CHO glycoforms 28–34 kDa) | PASS |
| Purity | RP-HPLC, UV 214 nm, area% | 99.0% | 99.18% | PASS |
| Largest impurity | RP-HPLC, area% | 1.0% | 0.42% at 6.44 min | PASS |
| Water content | Karl Fischer | 5.0% | 1.9% | PASS |
| Bacterial endotoxin | LAL, kinetic | ≤ 5.0 EU/mg | 0.27 EU/mg | PASS |
| Sterility / bioburden | USP <71>, membrane filtration | No growth after 14 days | No growth; conforms | PASS |
1HPLC chromatogram
Data file: EPO_PL-2609-031_20260919_01 · Column C18, 150 × 4.6 mm · UV 214 nm
Baseline uncropped; main peak (intact monomer glycoform cluster) and impurities labeled with retention times. Peak table on page 2.