{
  "@context": "https://molequa.com/coa/",
  "generatedAt": "2026-10-16",
  "reportNo": "AN-2026-00014",
  "key": "D4N4EZDVQM",
  "issued": "2026-08-01",
  "status": "issued",
  "sample": "Tirzepatide, lyophilised powder, vial labelled 5 mg",
  "batch": "ATTZP-05-2607-01",
  "batchSlug": "attzp-05-2607-01",
  "matrix": "Research peptide",
  "slug": "tirzepatide",
  "laboratory": {
    "name": "Analyton Labs",
    "url": "https://analyton.com/"
  },
  "pdf": "https://molequa.com/coa/tirzepatide.pdf",
  "json": "https://molequa.com/coa/tirzepatide.json",
  "sha256": "4d04161d08e034e12efe7293d46d5a7a26d15fd91c4fa4ff65de800beeb7e0bb",
  "verify": "https://analyton.com/verify/AN-2026-00014-D4N4EZDVQM/",
  "pages": {
    "sk": "https://molequa.com/sk/coa/tirzepatide/attzp-05-2607-01/",
    "cs": "https://molequa.com/cz/coa/tirzepatide/attzp-05-2607-01/",
    "en": "https://molequa.com/en/coa/tirzepatide/attzp-05-2607-01/",
    "hu": "https://molequa.com/hu/coa/tirzepatide/attzp-05-2607-01/",
    "pl": "https://molequa.com/pl/coa/tirzepatide/attzp-05-2607-01/",
    "nl": "https://molequa.com/nl/coa/tirzepatide/attzp-05-2607-01/",
    "ro": "https://molequa.com/ro/coa/tirzepatide/attzp-05-2607-01/",
    "de": "https://molequa.com/de/coa/tirzepatide/attzp-05-2607-01/",
    "at": "https://molequa.com/at/coa/tirzepatide/attzp-05-2607-01/",
    "es": "https://molequa.com/es/coa/tirzepatide/attzp-05-2607-01/",
    "bg": "https://molequa.com/bg/coa/tirzepatide/attzp-05-2607-01/",
    "fr": "https://molequa.com/fr/coa/tirzepatide/attzp-05-2607-01/",
    "fr-be": "https://molequa.com/fr-be/coa/tirzepatide/attzp-05-2607-01/",
    "nl-be": "https://molequa.com/nl-be/coa/tirzepatide/attzp-05-2607-01/",
    "pt": "https://molequa.com/pt/coa/tirzepatide/attzp-05-2607-01/",
    "it": "https://molequa.com/it/coa/tirzepatide/attzp-05-2607-01/",
    "sl": "https://molequa.com/sl/coa/tirzepatide/attzp-05-2607-01/",
    "da": "https://molequa.com/da/coa/tirzepatide/attzp-05-2607-01/"
  },
  "product": {
    "sk": "https://molequa.com/sk/peptidy/tirzepatide/",
    "cs": "https://molequa.com/cz/peptidy/tirzepatide/",
    "en": "https://molequa.com/en/peptidy/tirzepatide/",
    "hu": "https://molequa.com/hu/peptidy/tirzepatide/",
    "pl": "https://molequa.com/pl/peptidy/tirzepatide/",
    "nl": "https://molequa.com/nl/peptidy/tirzepatide/",
    "ro": "https://molequa.com/ro/peptidy/tirzepatide/",
    "de": "https://molequa.com/de/peptide/tirzepatide/",
    "at": "https://molequa.com/at/peptide/tirzepatide/",
    "es": "https://molequa.com/es/peptidos/tirzepatide/",
    "bg": "https://molequa.com/bg/peptidi/tirzepatide/",
    "fr": "https://molequa.com/fr/peptides/tirzepatide/",
    "fr-be": "https://molequa.com/fr-be/peptides/tirzepatide/",
    "nl-be": "https://molequa.com/nl-be/peptidy/tirzepatide/",
    "pt": "https://molequa.com/pt/peptidos/tirzepatide/",
    "it": "https://molequa.com/it/peptidi/tirzepatide/",
    "sl": "https://molequa.com/sl/peptidi/tirzepatide/",
    "da": "https://molequa.com/da/peptider/tirzepatide/"
  },
  "results": [
    {
      "determination": "Appearance",
      "method": "Visual",
      "result": "White to off-white lyophilised cake, free of visible particles",
      "spec": "White to off-white powder or cake"
    },
    {
      "determination": "Identity",
      "method": "LC-HRMS (ESI+), USP <621> principles",
      "result": "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+",
      "spec": "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",
      "kind": "identity"
    },
    {
      "determination": "Purity",
      "method": "RP-HPLC, C18, 214 nm, area %",
      "result": "99.25 ± 0.20 % (k = 2)",
      "spec": ">= 99.0 %",
      "kind": "purity"
    },
    {
      "determination": "Related substances",
      "method": "RP-HPLC, 214 nm; LOD 0.01 %, LOQ 0.03 %, reporting threshold 0.05 %",
      "result": "Largest single impurity 0.21 % at RRT 1.03 (± 0.02 %); total impurities 0.75 %, i.e. 0.038 mg per vial",
      "spec": "Single <= 0.5 %, total <= 1.0 %"
    },
    {
      "determination": "Impurity profile",
      "method": "RP-HPLC with LC-HRMS assignment",
      "result": "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)",
      "spec": "Peaks above 0.05 % reported (ICH Q3B)"
    },
    {
      "determination": "Net peptide content",
      "method": "Amino acid analysis after acid hydrolysis (AAA), eight stable residues",
      "result": "94.80 ± 1.3 % w/w (k = 2)",
      "spec": ">= 90 %"
    },
    {
      "determination": "Fill weight",
      "method": "Gravimetric, two vials",
      "result": "5.19 ± 0.05 mg (second vial 5.15 mg, difference 0.8 %)",
      "spec": "Labelled 5 mg"
    },
    {
      "determination": "Peptide per vial",
      "method": "Calculated from fill weight and net peptide content",
      "result": "4.92 mg per vial labelled 5 mg, i.e. 98.4 % of label",
      "spec": "95 to 105 % of label"
    },
    {
      "determination": "Counter-ion content",
      "method": "Ion chromatography (anion), suppressed conductivity",
      "result": "Acetate 2.40 % w/w (± 0.15 %), i.e. 0.12 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",
      "spec": "Acetate <= 5.0 %; trifluoroacetate <= 1000 ppm",
      "kind": "counterion"
    },
    {
      "determination": "Water content",
      "method": "Coulometric Karl Fischer, USP <921>",
      "result": "2.60 ± 0.15 % w/w (k = 2), i.e. 0.13 mg per vial",
      "spec": "<= 5.0 %",
      "kind": "water"
    },
    {
      "determination": "Mass balance",
      "method": "Peptide + counter-ion + water",
      "result": "94.80 + 2.40 + 2.60 = 99.80 % (± 1.3 %)",
      "spec": "Close to 100 %"
    },
    {
      "determination": "pH",
      "method": "Potentiometric, 10 mg/ml in water",
      "result": "6.8 (acidic peptide, pI 4.4, unbuffered)",
      "spec": "6.0 to 7.5"
    },
    {
      "determination": "Solubility",
      "method": "Visual, 10 mg/ml and 1 mg/ml",
      "result": ">= 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",
      "spec": "Clear solution"
    },
    {
      "determination": "Bacterial endotoxins",
      "method": "Kinetic chromogenic LAL, USP <85>",
      "result": "< 0.05 EU/mg (< 0.25 EU per vial; LOQ 0.005 EU/mg)",
      "spec": "<= 1.0 EU/mg",
      "kind": "endotoxin"
    },
    {
      "determination": "Sterility",
      "method": "Membrane filtration, USP <71>; fluid thioglycollate 30 to 35 °C and soya bean casein digest 20 to 25 °C",
      "result": "No growth after 14 days, 2 vials",
      "spec": "No growth",
      "kind": "sterility"
    },
    {
      "determination": "Microbial enumeration",
      "method": "Plate count, USP <61>; specified organisms, USP <62>",
      "result": "TAMC < 10 CFU/g, TYMC < 10 CFU/g; Escherichia coli, Salmonella, Staphylococcus aureus and Pseudomonas aeruginosa absent in 1 g",
      "spec": "TAMC <= 1000 CFU/g, TYMC <= 100 CFU/g; specified organisms absent",
      "kind": "bioburden"
    },
    {
      "determination": "Residual solvents",
      "method": "Headspace GC, USP <467>",
      "result": "Acetonitrile 38 ppm; N,N-dimethylformamide, methanol, dichloromethane, diethyl ether, diisopropyl ether, tert-butyl methyl ether and piperidine each < 10 ppm (LOQ 10 ppm)",
      "spec": "ICH Q3C: acetonitrile <= 410, DMF <= 880, methanol <= 3000, dichloromethane <= 600, ethers <= 5000 ppm",
      "kind": "solvents"
    },
    {
      "determination": "Elemental impurities",
      "method": "ICP-MS after microwave digestion (HNO3/H2O2), USP <233>",
      "result": "Cd, Pb, As, Hg < 0.05 µg/g; Co, V, Ni < 0.10 µg/g, all below LOQ",
      "spec": "ICH Q3D(R2) Class 1 and 2A, parenteral PDE per 5 mg daily: Cd 400, Pb 1000, As 3000, Hg 600, Co 1000, V 2000, Ni 4000 µg/g",
      "kind": "elemental"
    },
    {
      "determination": "Chiral purity (D-amino acids)",
      "method": "Acid hydrolysis (6 M DCl in D2O, 110 °C, 24 h; Trp after alkaline hydrolysis), Marfey's derivatisation (FDAA), LC-MS",
      "result": "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 %",
      "spec": "Each D-amino acid <= 0.2 %, sum of D-forms <= 0.5 %"
    },
    {
      "determination": "Compound screening",
      "method": "LC-HRMS full scan m/z 100 to 2000, both polarities, against reference standards",
      "result": "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",
      "spec": "Nothing above 0.05 %",
      "kind": "screen"
    }
  ],
  "delivery": {
    "labelled": "5 mg",
    "labelledMg": 5,
    "fillMg": 5.19,
    "contentPercent": 94.8
  },
  "controls": {
    "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 %)",
    "referenceStandard": "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"
  }
}