- Certificate
- IP-COA-GH-261005
- Issued
- 3 October 2026
- Status
- released
HGH 191AA
Recombinant human growth hormone, 191 amino acids, released on potency
- 10 IU
- 15 IU
- 24 IU
- IdentityConfirmedMass spectrometry
- Endotoxin< 0.1 EU/mgKinetic chromogenic LAL
- SterilityNo growthMembrane filtration
- Analysed2 October 2026Batch made 1 October 2026
Full analytical results
Tests and specifications
| Test | Method | Specification | Result | Status |
|---|---|---|---|---|
| Appearance | Visual inspection | White lyophilised powder or cake | Conforms | Pass |
| Purity | SEC-HPLC, monomer, 280 nm | ≥ 99.0% | 99.33% | Pass |
| Identity | ESI-MS, intact mass | [M+22H]22+ = 1006.69 ± 0.50 | 1006.87 | Pass |
| Aggregate content | SEC-HPLC, high molecular weight species | ≤ 1.0% | 0.16% | Pass |
| Protein content | UV absorbance at 280 nm | ≥ 95.0% of label claim | 98.6% | Pass |
| Potency | Bioassay against the international standard | ≥ 2.5 IU per mg | 2.85 IU per mg | Pass |
| Host cell protein | ELISA | ≤ 100 ppm | < 35 ppm | Pass |
| Residual host DNA | qPCR | ≤ 10 ng per vial | < 2 ng per vial | Pass |
| Residual moisture | Karl Fischer titration | ≤ 5.0% | 2.40% | Pass |
| Bacterial endotoxins | Kinetic chromogenic LAL | < 1.0 EU/mg | < 0.1 EU/mg | Pass |
| Sterility | Membrane filtration (USP <71>) | No growth | No growth | Pass |
| Elemental impurities | ICP-MS (USP <232> and <233>) | Pb ≤ 5, Cd ≤ 2, As ≤ 15, Hg ≤ 3 µg/day (ICH Q3D, parenteral) | Conforms | Pass |
Chromatogram
Size-exclusion trace for this batch. One dominant peak at 11.4 minutes, 99.33% of the total peak area, largest single impurity 0.16%.
Mass spectrum
Electrospray ionisation. Expected 1006.69, observed 1006.87, a difference of 0.18 m/z at charge state 22. The neighbouring peaks are the same molecule at the charge states either side of it.
Reference data
- Also known as
- Somatropin, rhGH
- CAS number
- 12629-01-5
- Molecular formula
- C990H1528N262O300S7
- Molecular weight
- 22125.07 g/mol
- Sequence
- FPTIPLSRLFDNAMLRAHRLHQLAFDTYQEFEEAYIPKEQKYSFLQNPQTSLCFSESIPTPSNREETQQKSNLELLRISLLLIQSWLEPVQFLRSVFANSLVYGASDSNVYDLLKDLEEGIQTLMGRLEDGSPRTGQIFKQTYSKFDTNSHNDDALLKNYGLLYCFRKDMDKVETFLRIVQCRSVEGSCGF
- Modifications
- Two disulfide bonds, Cys53 to Cys165 and Cys182 to Cys189. Not glycosylated, and with no extra methionine at the front.
Public reference values for the compound, not measurements on this batch. The batch measurements are in the table above.
Storage and handling
- Unopened
- 2 to 8 °C, away from light
- Long term
- −20 °C, lyophilised, for the stated shelf life
- Reconstituted
- 2 to 8 °C, use within 2 weeks; do not freeze and thaw
- In transit
- Stable at ambient temperature for up to 14 days
- Reconstitute with
- Bacteriostatic water
The vial this covers
The label on your vial carries the same batch code as this certificate, IP-GH-261001, and the QR goes to the results for it. If the code on the vial is not this one, the certificate for it is on this page under earlier batches.
Sticker shown at its printed size, 40 by 20 mm. Cap colour may vary by batch.
Release
- Batch date
- 1 October 2026
- Analysis date
- 2 October 2026
- Issue date
- 3 October 2026
- Best before
- October 2028
- Released by
- Quality review, Indigo Peptides
- Document
- Valid only in its original, unmodified form
Results are taken from the batch testing documentation for this exact batch, supplied with the finished vials and held on file by us. Every value above is for the batch named on this certificate and for no other.
Holding an older vial?
| Batch | purity | Analysed |
|---|---|---|
| IP-GH-260912 | 99.32% | 13 September 2026 |
If the code on your vial is one of these, it is an earlier batch of ours and these are its results. A result we have published is never removed and never recalculated.
Take it with you
Download this certificate (PDF)
The PDF is this page on A4. Open the printable version to print it yourself.