{ "@context": "https://molequa.com/coa/", "generatedAt": "2026-09-23", "reportNo": "AN-2026-00013", "key": "GH6229FYYE", "issued": "2026-09-22", "status": "issued", "sample": "Cagrilintide, lyophilised powder, vial labelled 5 mg", "batch": "ATCAG-05-2408-01", "batchSlug": "atcag-05-2408-01", "matrix": "Research peptide", "slug": "cagrilintide", "laboratory": { "name": "Analyton Labs", "url": "https://analyton.com/" }, "pdf": "https://molequa.com/coa/cagrilintide.pdf", "json": "https://molequa.com/coa/cagrilintide.json", "sha256": "9718e6f7dddf411e8d6a665dc6607c71f0496e862b44bdbd10b299d5c41c89a9", "verify": "https://analyton.com/verify/AN-2026-00013-GH6229FYYE/", "pages": { "sk": "https://molequa.com/sk/coa/cagrilintide/atcag-05-2408-01/", "cs": "https://molequa.com/cz/coa/cagrilintide/atcag-05-2408-01/", "en": "https://molequa.com/en/coa/cagrilintide/atcag-05-2408-01/", "hu": "https://molequa.com/hu/coa/cagrilintide/atcag-05-2408-01/", "pl": "https://molequa.com/pl/coa/cagrilintide/atcag-05-2408-01/", "nl": "https://molequa.com/nl/coa/cagrilintide/atcag-05-2408-01/", "ro": "https://molequa.com/ro/coa/cagrilintide/atcag-05-2408-01/", "de": "https://molequa.com/de/coa/cagrilintide/atcag-05-2408-01/", "at": "https://molequa.com/at/coa/cagrilintide/atcag-05-2408-01/", "es": "https://molequa.com/es/coa/cagrilintide/atcag-05-2408-01/", "bg": "https://molequa.com/bg/coa/cagrilintide/atcag-05-2408-01/", "fr": "https://molequa.com/fr/coa/cagrilintide/atcag-05-2408-01/", "fr-be": "https://molequa.com/fr-be/coa/cagrilintide/atcag-05-2408-01/", "nl-be": "https://molequa.com/nl-be/coa/cagrilintide/atcag-05-2408-01/", "pt": "https://molequa.com/pt/coa/cagrilintide/atcag-05-2408-01/" }, "product": { "sk": "https://molequa.com/sk/peptidy/cagrilintide/", "cs": "https://molequa.com/cz/peptidy/cagrilintide/", "en": "https://molequa.com/en/peptidy/cagrilintide/", "hu": "https://molequa.com/hu/peptidy/cagrilintide/", "pl": "https://molequa.com/pl/peptidy/cagrilintide/", "nl": "https://molequa.com/nl/peptidy/cagrilintide/", "ro": "https://molequa.com/ro/peptidy/cagrilintide/", "de": "https://molequa.com/de/peptide/cagrilintide/", "at": "https://molequa.com/at/peptide/cagrilintide/", "es": "https://molequa.com/es/peptidos/cagrilintide/", "bg": "https://molequa.com/bg/peptidi/cagrilintide/", "fr": "https://molequa.com/fr/peptides/cagrilintide/", "fr-be": "https://molequa.com/fr-be/peptides/cagrilintide/", "nl-be": "https://molequa.com/nl-be/peptidy/cagrilintide/", "pt": "https://molequa.com/pt/peptidos/cagrilintide/" }, "results": [ { "determination": "Appearance", "method": "Visual", "result": "White to off-white powder", "spec": "White to off-white powder" }, { "determination": "Purity", "method": "RP-HPLC, C18, 214 nm (280 nm control trace), area %", "result": "99.23 ± 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 0.34 % at RRT 1.03 (± 0.03 %); total impurities 0.77 %, 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 0.82, 0.13 %, minus lipid (peptide without the lipid chain); RRT 0.91, 0.13 %, -97.05 Da (des-Pro); RRT 1.03, 0.34 %, +0.98 Da (deamidation of Gln/Asn, 6x in sequence); RRT 1.18, 0.17 %, twice the mass (dimer through a rearranged disulfide)", "spec": "Peaks above 0.05 % reported (ICH Q3B)" }, { "determination": "Net peptide content", "method": "Assay", "result": "88.33 ± 1.2 % w/w (k = 2)", "spec": ">= 80.0 %" }, { "determination": "Fill weight", "method": "Gravimetric", "result": "5.52 ± 0.05 mg", "spec": "Labelled 5 mg" }, { "determination": "Peptide per vial", "method": "Calculated from fill weight and net peptide content", "result": "4.88 mg per vial labelled 5 mg, i.e. 97.5 % of label", "spec": "95 to 105 % of label" }, { "determination": "Vial-to-vial consistency", "method": "Gravimetric, two vials of the batch", "result": "5.52 and 5.66 mg, difference 2.5 %; purity of both within 0.1 %", "spec": "<= 5 %" }, { "determination": "Counter-ion content", "method": "Ion chromatography, suppressed conductivity", "result": "Acetate 6.51 % w/w (± 0.39 %), i.e. 0.36 mg per vial", "spec": "<= 8.0 %" }, { "determination": "Trifluoroacetate", "method": "Ion chromatography, LOQ 20 ppm", "result": "Not detected", "spec": "<= 1000 ppm" }, { "determination": "Water content", "method": "Coulometric Karl Fischer, USP <921>", "result": "4.83 ± 0.24 % w/w (k = 2), i.e. 0.27 mg per vial", "spec": "<= 8.0 %", "kind": "water" }, { "determination": "Mass balance", "method": "Peptide + counter-ion + water", "result": "88.33 + 6.51 + 4.83 = 99.67 % (± 1.3 %)", "spec": "Close to 100 %" }, { "determination": "pH", "method": "Potentiometric, 5 mg/ml in water", "result": "5.2", "spec": "4.4 to 6.0" }, { "determination": "Solubility", "method": "Visual, 5 mg/ml and 1 mg/ml", "result": ">= 5 mg/ml in water and in bacteriostatic water; clear, colourless, free of particles within 30 s. Lipidated peptide: dissolve at pH 7.5, opalescent below pH 6", "spec": "Clear solution" }, { "determination": "Bacterial endotoxins", "method": "Kinetic chromogenic LAL, USP <85>", "result": "< 0.05 EU/mg (< 0.28 EU per vial)", "spec": "<= 10 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": "Residual solvents", "method": "Headspace GC, USP <467>", "result": "Acetonitrile 122 ppm; methanol, dichloromethane and N,N-dimethylformamide not detected", "spec": "ICH Q3C: acetonitrile <= 410, methanol <= 3000, dichloromethane <= 600, DMF <= 880 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", "kind": "elemental" }, { "determination": "Chiral purity (D-amino acids)", "method": "Acid hydrolysis (6 M DCl in D2O, 110 °C, 24 h), Marfey's derivatisation (FDAA), LC-MS", "result": "D-Cys 0.10 %, D-His 0.10 %, D-Ser 0.08 %, D-Phe 0.06 %, D-Asn 0.05 %, D-Thr 0.05 %, D-Gln 0.05 %, D-Glu 0.05 %, others < 0.05 %; Gly achiral; sum of D-forms 0.68 %", "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, against library: fentanyl and analogues, retatrutide, semaglutide, pramlintide, protected intermediates (tBu, Boc, Trt, Pbf, Fmoc), free amino acids", "result": "None detected above 0.05 % area", "spec": "No foreign compound above 0.05 % area", "kind": "screen" } ], "delivery": { "labelled": "5 mg", "labelledMg": 5, "fillMg": 5.52, "contentPercent": 88.33 }, "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", "referenceStandard": "In-house reference standard RS-CAG-01 (purity assigned against a primary standard, stored at -20 °C) injected at the start and end of the sequence; area difference 0.4 %, retention time within 0.1 min" } }