Historical reference transcription
Manufacturer Certificate of Analysis
HISTORICAL REFERENCE ONLY — NOT CURRENT STOCK
This is a typed public summary of a separately sourced historical manufacturer COA. Its lot has NOT been matched to the Testides reference sample or THAI BIO LABS inventory. Do not treat these results as evidence for stock release. Supplier identifiers are withheld for commercial confidentiality. The original factory PDF is not published.
- Product
- Retatrutide
- Strength
- 10 mg
- Manufacturer batch
- Withheld
- Project code
- Withheld
- Manufacturing date
- 2026-05-19
- Retest date
- 2028-05-18
- Molecular formula
- C221H342N46O68
- Test basis
- Quality specification · internal method withheld
Analytical results
Reported manufacturer QC panel.
| Test | Acceptance criteria | Result |
|---|---|---|
| Appearance | White to off-white powder | White powder |
| Specific Optical Rotation | [α]D20 = -30° to -33° (anhydrous and salt-free basis) | -32° |
| pH | 7.0–9.0 | 7.5 |
| Solubility · water | Can be dissolved to 100 mg/mL in pure water | Conforms |
| Solubility · solvent profile | Freely soluble in water; very soluble in methanol; practically insoluble in acetonitrile and DMSO | Conforms |
| Identification · MS | 4728.47 ± 1.0 Da (monoisotopic molecular weight) | 4728.77 |
| Identification · retention time | Main-peak retention-time ratio to reference solution: 1.00 ± 0.03 | 1.00 |
| Identification · peptide mapping | Consistent with the reference substance | Conforms |
| Clarity and color of solution | Clear and colorless | Conforms |
| Water content (w/w) | ≤ 8.0% | 4.2% |
| Amino acid analysis | Glu 4.0–6.0; Ser 4.0–6.0; Gly 3.2–4.8; Ala 2.4–3.6; Thr 1.6–2.4; Tyr 2.4–3.6; Ile 1.6–2.4; Leu 2.4–3.6; Pro 3.2–4.8; Asp 1.6–2.4; Phe 1.6–2.4; Lys 1.6–2.4; Aib 1.6–2.4 | Glu 4.1; Ser 5.0; Gly 3.7; Ala 3.1; Thr 2.0; Tyr 2.7; Ile 1.9; Leu 2.8; Pro 3.9; Asp 2.1; Phe 1.7; Lys 2.2; Aib 2.0 |
| Purity (area/area) | ≥ 98.0% | 99.11% |
| Related substance · IMA | ≤ 0.8% | 0.16% |
| Related substance · IMB | ≤ 0.8% | 0.19% |
| Any unspecified impurity | ≤ 0.5% | 0.21% |
| Total impurities | ≤ 2.0% | 0.89% |
| Polymer · dimer | ≤ 0.5% | ND |
| Sodium ion (w/w) | ≤ 5.0% | 2.2% |
| Acetate ion | ≤ 0.1% | 0.06% |
| Trifluoroacetate ion | ≤ 0.1% | ND |
| Phosphate ion | ≤ 0.1% | ND |
| Residual solvent · DCM | ≤ 600 ppm | ND |
| Residual solvent · ACN | ≤ 410 ppm | 109 ppm |
| Residual solvent · MeOH | ≤ 3000 ppm | ND |
| Residual solvent · DMF | ≤ 880 ppm | ND |
| Residual solvent · MTBE | ≤ 5000 ppm | 14 ppm |
| Assay (w/w) | 95.0%–105.0% of material, calculated on anhydrous and salt-free basis | 99.4% |
| Peptide content | ≥ 80.0% | 92.8% |
| Bacterial endotoxins | ≤ 5 EU/mg | Conforms |
| Microbial enumeration · TAMC | ≤ 100 cfu/g | 20 cfu/g |
| Microbial enumeration · TYMC | ≤ 100 cfu/g | 10 cfu/g |
ConclusionConforms with the product standards.
Initiator and reviewer identities are withheld in the public copy. Approval date: 2026-06-12.
