Verification · Certificates issued
Certificate AN-2026-00014
Valid
Issued
This certificate was issued by ANALYTON and has not been withdrawn.
Verification confirms that a certificate with this number and key was issued by ANALYTON on the date shown, for the sample described, and states its current status.
| Report number | AN-2026-00014 |
| Issued | 2026-08-01 |
| Status | Valid |
| Sample | Tirzepatide, lyophilised powder, vial labelled 10 mg |
| Batch number | ATTZP-10-2607-01 |
| Matrix | Research peptide |
| Determinations performed | 19 |
| Issued by | ANALYTON |
| Certificate file | AN-2026-00014.pdf |
Labelled 10 mg / 9.84 mg peptide / 98.4% of label
The container was labelled 10 mg and held 10.38 mg of powder when weighed. Net peptide content of that powder is 94.8% w/w, so the peptide in the container is 9.84 mg.
| Determination | Method | Result | Specification |
|---|---|---|---|
| Appearance | Visual | White to off-white lyophilised cake, free of visible particles | White to off-white powder or cake Pass |
| Identity | LC-HRMS (ESI+), USP <621> principles | Deconvoluted monoisotopic mass 4810.529 Da, deviation 0.8 ppm (0.004 Da); observed m/z 1604.516 (3+), 1203.638 (4+), 963.112 (5+); charge envelope 3+ to 6+ | Theoretical monoisotopic 4810.525 Da from C225H348N48O68 (average 4813.5 Da); expected m/z 1604.516 (3+), 1203.638 (4+), 963.112 (5+); deviation <= 10 ppm Pass |
| Purity | RP-HPLC, C18, 214 nm, area % | 99.25 ± 0.20 % (k = 2) | >= 99.0 % Pass |
| Related substances | RP-HPLC, 214 nm; LOD 0.01 %, LOQ 0.03 %, reporting threshold 0.05 % | Largest single impurity 0.21 % at RRT 1.03 (± 0.02 %); total impurities 0.75 %, i.e. 0.075 mg per vial | Single <= 0.5 %, total <= 1.0 % Pass |
| Impurity profile | RP-HPLC with LC-HRMS assignment | RRT 0.93, 0.12 %, -18 Da (Asp9 or Asp15 succinimide); RRT 0.97, 0.17 %, same mass (isoAsp9 or isoAsp15); RRT 1.03, 0.21 %, +0.98 Da (deamidation of Gln19 or Gln24); RRT 1.06, 0.09 %, -28.03 Da (C18 diacid analogue, acyl chain short by C2H4); RRT 1.12, 0.16 %, +16 Da (Trp25 or Tyr oxidation) | Peaks above 0.05 % reported (ICH Q3B) |
| Net peptide content | Amino acid analysis after acid hydrolysis (AAA), eight stable residues | 94.80 ± 1.3 % w/w (k = 2) | >= 90 % Pass |
| Fill weight | Gravimetric, two vials | 10.38 ± 0.05 mg (second vial 10.31 mg, difference 0.7 %) | Labelled 10 mg Report only |
| Peptide per vial | Calculated from fill weight and net peptide content | 9.84 mg per vial labelled 10 mg, i.e. 98.4 % of label | 95 to 105 % of label Pass |
| Counter-ion content | Ion chromatography (anion), suppressed conductivity | Acetate 2.40 % w/w (± 0.15 %), i.e. 0.25 mg per vial, 1.9 mol per mol at two basic sites (Tyr1 N-terminus and Lys16; Lys20 carries the acyl chain); trifluoroacetate < 20 ppm (LOQ 20 ppm); chloride and phosphate < 20 ppm | Acetate <= 5.0 %; trifluoroacetate <= 1000 ppm Pass |
| Water content | Coulometric Karl Fischer, USP <921> | 2.60 ± 0.15 % w/w (k = 2), i.e. 0.27 mg per vial | <= 5.0 % Pass |
| Mass balance | Peptide + counter-ion + water | 94.80 + 2.40 + 2.60 = 99.80 % (± 1.3 %) | Close to 100 % Pass |
| pH | Potentiometric, 10 mg/ml in water | 6.8 (acidic peptide, pI 4.4, unbuffered) | 6.0 to 7.5 Pass |
| Solubility | Visual, 10 mg/ml and 1 mg/ml | >= 10 mg/ml in water and in bacteriostatic water; clear, colourless, free of particles within 60 s (lipidated peptide wets slowly); no opalescence after 24 h at 2 to 8 °C | Clear solution Pass |
| Bacterial endotoxins | Kinetic chromogenic LAL, USP <85> | < 0.05 EU/mg (< 0.5 EU per vial; LOQ 0.005 EU/mg) | <= 1.0 EU/mg Pass |
| Sterility | Membrane filtration, USP <71>; fluid thioglycollate 30 to 35 °C and soya bean casein digest 20 to 25 °C | No growth after 14 days, 2 vials | No growth Pass |
| Microbial enumeration | Plate count, USP <61>; specified organisms, USP <62> | TAMC < 10 CFU/g, TYMC < 10 CFU/g; Escherichia coli, Salmonella, Staphylococcus aureus and Pseudomonas aeruginosa absent in 1 g | TAMC <= 1000 CFU/g, TYMC <= 100 CFU/g; specified organisms absent Pass |
| Residual solvents | Headspace GC, USP <467> | Acetonitrile 38 ppm; N,N-dimethylformamide, methanol, dichloromethane, diethyl ether, diisopropyl ether, tert-butyl methyl ether and piperidine each < 10 ppm (LOQ 10 ppm) | ICH Q3C: acetonitrile <= 410, DMF <= 880, methanol <= 3000, dichloromethane <= 600, ethers <= 5000 ppm Pass |
| Elemental impurities | ICP-MS after microwave digestion (HNO3/H2O2), USP <233> | Cd, Pb, As, Hg < 0.05 µg/g; Co, V, Ni < 0.10 µg/g, all below LOQ | ICH Q3D(R2) Class 1 and 2A, parenteral PDE per 10 mg daily: Cd 200, Pb 500, As 1500, Hg 300, Co 500, V 1000, Ni 2000 µg/g Pass |
| Chiral purity (D-amino acids) | Acid hydrolysis (6 M DCl in D2O, 110 °C, 24 h; Trp after alkaline hydrolysis), Marfey's derivatisation (FDAA), LC-MS | D-Tyr 0.05 %, D-Ser 0.05 %, D-Glu (Glu + Gln) 0.04 %, D-Phe 0.04 %, D-Thr 0.03 %, D-Asp 0.03 %, D-Ile 0.02 %, D-Leu 0.02 %, others < 0.02 %; Aib and Gly achiral; sum of D-forms 0.28 % | Each D-amino acid <= 0.2 %, sum of D-forms <= 0.5 % Pass |
| Compound screening | LC-HRMS full scan m/z 100 to 2000, both polarities, against reference standards | Fentanyl and analogues, semaglutide, liraglutide, retatrutide, GLP-1 (7-37), GIP (1-42), cagrilintide, protected intermediates (tBu, Boc, Trt, Pbf, Fmoc, protected acyl chain) and free amino acids: none above 0.05 % of area | Nothing above 0.05 % Pass |
| Blank | Solvent blank (mobile phase A) injected before the sequence; no peak above 0.02 % of the main peak within RRT 0.80 to 1.30 (maximum 0.003 %) |
| Reference standard | In-house reference standard RS-TZP-01 (purity assigned against a primary standard, stored at -20 °C) injected at the start and end of the sequence; area difference 0.3 %, retention time within 0.1 min; control sample from the previous batch within 0.2 % of its value |
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781b5a9ebe6d4483ea3e981a0154ec438bc9014485ce7c5fa4f5fc13fb1634d1
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