Certificate of Analysis
Tesamorelin20mg / vial · Full QC Panel
Report number
ASC-2024-0821-066
Certified
September 3, 2024
Access code
QP4YSXXC
Scan to verify
Purity
99.8%
Net content
20.3 mg
Identity
PASS
Sterility
PASS
Endotoxin
PASS
Heavy metals
PASS
Sample
Client / brand
Ascend Research
Product
Tesamorelin
Batch number
AR-TES-20-2408
Product form
Lyophilized powder in vial
Labeled quantity
20mg / vial
Fill volume
3mL
Molecular formula
C221H366N72O67S
Molecular weight
5,135.86 g/mol
CAS number
218949-48-5
Test Results
| Analyte | Specification | Result | Unit | Status |
|---|---|---|---|---|
| Peptide Purity (HPLC) | >= 95.0% | 99.8% | % | PASS |
| Net Peptide Content | Not less than label claim | 20.3 | mg | CONFIRMED |
| Identity (HPLC-RT) | Matches reference standard | Confirmed | — | PASS |
| Heavy Metals (ICP-MS) | As, Cd, Pb, Hg, Cr within limits | See detail | ppm | PASS |
| Sterility (PCR) | No growth detected | No Growth | — | PASS |
| Endotoxin (kinetic chromogenic) | < 0.25 EU/mL | 0.1 | EU/mL | PASS |
| Fentanyl Presence Analysis | Not detected | Not Detected | — | PASS |
Analytical Method
Method RP-HPLC (USP <621>)
Column C18, 4.6 x 150 mm, 3.5 um
Mobile phase A: 0.1% TFA in water / B: 0.1% TFA in acetonitrile
Gradient 5-65% B over 20 min
Detection UV 214 nm
Flow rate 1.0 mL/min
Injection 10 uL
Retention time 8.45 min
Notes & Methodology
- Peptide purity determined by RP-HPLC area normalization at 214 nm. The reported value is the percentage of the target peptide relative to all peptide-related peaks. Non-peptide process-related impurities, if detected, are excluded from the calculation.
- Identity confirmed by comparison of chromatographic retention time against a characterized reference standard.
- Elemental impurities analyzed by ICP-MS following USP <233> methodology. Acceptance criteria are internal laboratory screening limits for research-use materials and do not represent evaluation against any pharmacopeial monograph or product specification.
- Sterility screening performed by PCR (polymerase chain reaction). This is a nucleic-acid detection method and is not equivalent to a compendial sterility test.
- Bacterial endotoxin determined by USP <85> kinetic chromogenic method.
- This certificate reports analytical results for the sample(s) submitted to United Diagnostics for testing. Sample identification, product name, brand, lot number and labeled content are provided by the submitting party and have not been independently verified. Results reflect only the analytical testing of the specific sample(s) provided and do not constitute an evaluation or endorsement of the manufacturer's processes, quality systems, or overall production.
- United Diagnostics makes no representations regarding the intended use, safety, efficacy, regulatory status, or intellectual property ownership of any material tested. Materials tested are for research use only and are not for human or veterinary use, and not for diagnostic or therapeutic use.
Analyzed by
Alisa Morovitz
Analytical Chemist
Analysis completed 09/02/2024
Reviewed & authorized by
Evan Atkinson
Principal Chemist
Authorized 09/03/2024