Lot / batch number
PL-2609-046
PrymaLab
PrymaLab Analytical · In-house laboratory
3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net
Certificate no.
PL-26-00046
Verification key
9WNXD2PS
Scan or enter both at
prymalab.net/testing/verify
prymalab.net/testing/verify
Certificate of Analysis · Lot release
HCG 5,000 IU
Lot PL-2609-046 · Lyophilized powder · Label claim 5,000 IU/vial (≈ 0.5 mg glycoprotein, standardized by bioassay)
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
Certificate type
Lot COA, 2 pages
Compound
HCG
Human chorionic gonadotropin (urinary); potency assigned in IU by bioassay
CAS number
9002-61-3
Molecular formula
Not applicable (glycoprotein)
Theoretical mass (avg.)
About 36–38 kDa glycoform average; 25.7 kDa protein core (about 30% carbohydrate)
Structure
Non-covalent heterodimer, 237 residues in total: common glycoprotein-hormone α-subunit (92 aa) paired with the hCG β-subunit (145 aa, including the 24-residue C-terminal peptide); 11 disulfides; N- and O-glycosylated.
Purity · RP-HPLC, area %
99.20%
Specification 99.0% • main peak (glycoform cluster) at 7.28 min
Identity · Observed Mass
36,712 Da
Deconvoluted glycoform centroid • theoretical 36.7 kDa average
Overall conclusion
PASS
Meets every specification for the tests performed
| Test | Method | Specification | Result | Conclusion |
|---|---|---|---|---|
| Appearance | Visual inspection | White to off-white lyophilized powder or cake | White lyophilized cake | PASS |
| Identity (mass) | LC-MS, ESI positive | Within glycoform envelope | 36,712 Da centroid (glycoforms 36–38 kDa) | PASS |
| Purity | RP-HPLC, UV 214 nm, area% | 99.0% | 99.20% | PASS |
| Largest impurity | RP-HPLC, area% | 1.0% | 0.32% at 6.58 min (free β-subunit) | PASS |
| Water content | Karl Fischer | 5.0% | 1.7% | PASS |
| Bacterial endotoxin | LAL, kinetic | ≤ 5.0 EU/mg | 0.22 EU/mg | PASS |
| Sterility / bioburden | USP <71>, membrane filtration | No growth after 14 days | No growth; conforms | PASS |
1HPLC chromatogram
Data file: HCG_PL-2609-046_20260919_01 · Column C18, 150 × 4.6 mm · UV 214 nm
Baseline uncropped; main peak (intact heterodimer glycoform cluster) and impurities labeled with retention times. Peak table on page 2.