Tesamorelin + Ipamorelin Blend 10mg
Two-component batch verification: Tesamorelin + Ipamorelin. Individual BVRs for each component are presented below.
Batch Verification Report
Tesamorelin — batch verification and analytical summary.
Analysis date: 30 Oct 2025
Recommended retest date: 29 Oct 2027
Molecular weight: 5135.78 Da (manufacturer ESI-MS)
Solubility: ≥5 mg/mL (water)
Analytical Results
The following analytical data was obtained from manufacturer testing of batch P250919-A018. Aventris has independently reviewed this data against our quality specifications. One deviation is noted and disclosed below.
| Parameter | Specification | Result | Status |
|---|---|---|---|
| Appearance | White powder | Conforms | PASS |
| Solubility (water) | ≥5 mg/mL | Conforms | PASS |
| Molecular Weight (ESI-MS) | Conforms to structure | 5135.78 Da | PASS |
| Purity (HPLC) | ≥98.0% | 98.83% | PASS |
| Peptide Content (N%) | ≥80.0% | 88.57% | PASS |
| Water Content (Karl Fischer) | ≤7.0% | 5.13% | PASS |
| Acetate Content (HPLC) | <10.0% | 5.78% | PASS |
| Total Aerobic Microbial Count | ≤100 cfu/g | Conforms | PASS |
| Total Yeast and Mould Count | ≤100 cfu/g | Conforms | PASS |
| Bacterial Endotoxins | <10 EU/mg | Conforms | PASS |
| Mass Balance | 95.0–105.0% | 99.48% | PASS |
Amino Acid Analysis
| Residue | Specification | Result | Status |
|---|---|---|---|
| Asp | 3.2–4.8 | 3.33 | PASS |
| Tyr | 1.6–2.4 | 2.39 | PASS |
| Lys | 1.6–2.4 | 1.79 | PASS |
| Ile | 1.6–2.4 | 2.18 | PASS |
| Leu | 4.0–6.0 | 4.95 | PASS |
| Val | 0.8–1.2 | 0.94 | PASS |
| Thr | 0.8–1.2 | 1.00 | PASS |
| Phe | 0.8–1.2 | 0.98 | PASS |
| Ser | 3.2–4.8 | 4.32 | PASS |
| Ala | 4.0–6.0 | 4.69 | PASS |
| Gly | 2.4–3.6 | 3.05 | PASS |
| Glu | 5.6–8.4 | 6.93 | PASS |
| Met | 0.8–1.2 | 1.76 * | ACCEPTED |
| Arg | 4.8–7.2 | 6.51 | PASS |
Storage & Handling
- Store at -20°C or below in original sealed container
- Protect from light and moisture
- Allow to equilibrate to room temperature before opening
- Recommended shelf life: 24 months when stored properly
Laboratory Handling:
- Handle using standard laboratory safety practices
- Wear appropriate PPE (gloves, lab coat, safety glasses)
- Avoid inhalation, ingestion, or skin/eye contact
Reconstitution:
Reconstitution methods must be determined by qualified researchers according to their specific experimental
protocols and institutional guidelines. Aventris does not provide reconstitution instructions.
QA Decision — Methionine Variance:
The methionine residue result is a well-documented analytical limitation of the amino acid hydrolysis method,
in which methionine is partially oxidised to methionine sulfoxide and sulfone during sample preparation, producing
elevated apparent counts. Purity (98.83% HPLC), ESI-MS mass confirmation, mass balance, and all other 13 amino
acid residues conform. Aventris QA has reviewed the full dataset and approved this batch for distribution with
full disclosure.
Batch Verification Report
Ipamorelin — batch verification and analytical summary.
Analysis date: 29 Oct 2025
Recommended retest date: 28 Oct 2027
Molecular weight: 711.85 Da
Molecular formula: C₃₈H₄₉N₉O₅
Analytical Results
The following analytical data was obtained from manufacturer testing of batch P251018-A010. Aventris has independently reviewed this data against our quality specifications.
| Parameter | Specification | Result | Status |
|---|---|---|---|
| Appearance | White powder | Conforms | PASS |
| Molecular Weight (ESI-MS) | Conforms to structure | 712.03 Da | PASS |
| Purity (HPLC) | ≥98.0% | 99.45% | PASS |
| Peptide Content (N%) | ≥70.0% | 73.73% | PASS |
| Water Content (Karl Fischer) | ≤10.0% | 2.87% | PASS |
| Acetate Content (HPLC) | <20.0% | 19.02% | PASS |
| Mass Balance | 95.0–105.0% | 95.62% | PASS |
Storage & Handling
- Store at -20°C or below in original sealed container
- Protect from light and moisture
- Allow to equilibrate to room temperature before opening
- Recommended shelf life: 24 months when stored properly
Laboratory Handling:
- Handle using standard laboratory safety practices
- Wear appropriate PPE (gloves, lab coat, safety glasses)
- Avoid inhalation, ingestion, or skin/eye contact
Reconstitution:
Reconstitution methods must be determined by qualified researchers according to their specific experimental
protocols and institutional guidelines. Aventris does not provide reconstitution instructions.
All parameters conform to stated specification. No deviations noted for this component.