{ "@context": "https://molequa.com/coa/", "generatedAt": "2026-09-23", "reportNo": "AN-2026-00006", "key": "J8HMCB6SJE", "issued": "2026-09-22", "status": "issued", "sample": "Epithalon, lyophilised powder, vial labelled 10 mg", "batch": "ATEPI-10-2512-01", "batchSlug": "atepi-10-2512-01", "matrix": "Research peptide", "slug": "epithalon", "laboratory": { "name": "Analyton Labs", "url": "https://analyton.com/" }, "pdf": "https://molequa.com/coa/epithalon.pdf", "json": "https://molequa.com/coa/epithalon.json", "sha256": "7fc9fb4c0572866e3e988b1cf6c4a027596d5ee34f52b97283b3fbec67d2382b", "verify": "https://analyton.com/verify/AN-2026-00006-J8HMCB6SJE/", "pages": { "sk": "https://molequa.com/sk/coa/epithalon/atepi-10-2512-01/", "cs": "https://molequa.com/cz/coa/epithalon/atepi-10-2512-01/", "en": "https://molequa.com/en/coa/epithalon/atepi-10-2512-01/", "hu": "https://molequa.com/hu/coa/epithalon/atepi-10-2512-01/", "pl": "https://molequa.com/pl/coa/epithalon/atepi-10-2512-01/", "nl": "https://molequa.com/nl/coa/epithalon/atepi-10-2512-01/", "ro": "https://molequa.com/ro/coa/epithalon/atepi-10-2512-01/", "de": "https://molequa.com/de/coa/epithalon/atepi-10-2512-01/", "at": "https://molequa.com/at/coa/epithalon/atepi-10-2512-01/", "es": "https://molequa.com/es/coa/epithalon/atepi-10-2512-01/", "bg": "https://molequa.com/bg/coa/epithalon/atepi-10-2512-01/", "fr": "https://molequa.com/fr/coa/epithalon/atepi-10-2512-01/", "fr-be": "https://molequa.com/fr-be/coa/epithalon/atepi-10-2512-01/", "nl-be": "https://molequa.com/nl-be/coa/epithalon/atepi-10-2512-01/", "pt": "https://molequa.com/pt/coa/epithalon/atepi-10-2512-01/" }, "product": { "sk": "https://molequa.com/sk/peptidy/epithalon/", "cs": "https://molequa.com/cz/peptidy/epithalon/", "en": "https://molequa.com/en/peptidy/epithalon/", "hu": "https://molequa.com/hu/peptidy/epithalon/", "pl": "https://molequa.com/pl/peptidy/epithalon/", "nl": "https://molequa.com/nl/peptidy/epithalon/", "ro": "https://molequa.com/ro/peptidy/epithalon/", "de": "https://molequa.com/de/peptide/epithalon/", "at": "https://molequa.com/at/peptide/epithalon/", "es": "https://molequa.com/es/peptidos/epithalon/", "bg": "https://molequa.com/bg/peptidi/epithalon/", "fr": "https://molequa.com/fr/peptides/epithalon/", "fr-be": "https://molequa.com/fr-be/peptides/epithalon/", "nl-be": "https://molequa.com/nl-be/peptidy/epithalon/", "pt": "https://molequa.com/pt/peptidos/epithalon/" }, "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, area %", "result": "99.93 ± 0.20 % (k = 2)", "spec": ">= 98.0 %", "kind": "purity" }, { "determination": "Related substances", "method": "RP-HPLC, 214 nm; LOD 0.01 %, LOQ 0.03 %, reporting threshold 0.05 %", "result": "Largest single impurity 0.07 % at RRT 0.96 (± 0.03 %); total impurities 0.07 %, i.e. 0.006 mg per vial", "spec": "Single <= 1.0 %, total <= 2.0 %" }, { "determination": "Impurity profile", "method": "RP-HPLC with LC-HRMS assignment", "result": "RRT 0.96, 0.07 %, same mass (isoAsp)", "spec": "Peaks above 0.05 % reported (ICH Q3B)" }, { "determination": "Net peptide content", "method": "Assay", "result": "84.14 ± 1.2 % w/w (k = 2)", "spec": "" }, { "determination": "Fill weight", "method": "Gravimetric", "result": "10.95 ± 0.05 mg", "spec": "Labelled 10 mg" }, { "determination": "Peptide per vial", "method": "Calculated from fill weight and net peptide content", "result": "9.21 mg per vial labelled 10 mg, i.e. 92.1 % of label", "spec": "95 to 105 % of label" }, { "determination": "Vial-to-vial consistency", "method": "Gravimetric, two vials of the batch", "result": "10.95 and 10.90 mg, difference 0.5 %", "spec": "<= 5 %" }, { "determination": "Counter-ion content", "method": "Ion chromatography, suppressed conductivity", "result": "Acetate 9.50 % w/w (± 0.57 %), i.e. 1.04 mg per vial", "spec": "" }, { "determination": "Trifluoroacetate", "method": "Ion chromatography, LOQ 20 ppm", "result": "Not detected", "spec": "" }, { "determination": "Water content", "method": "Coulometric Karl Fischer, USP <921>", "result": "5.80 ± 0.29 % w/w (k = 2), i.e. 0.64 mg per vial", "spec": "<= 8.0 %", "kind": "water" }, { "determination": "Mass balance", "method": "Peptide + counter-ion + water", "result": "84.14 + 9.50 + 5.80 = 99.44 % (± 1.3 %)", "spec": "Close to 100 %" }, { "determination": "pH", "method": "Potentiometric, 10 mg/ml in water", "result": "5.2", "spec": "4.4 to 6.0" }, { "determination": "Solubility", "method": "Visual", "result": ">= 100 mg/ml in water", "spec": ">= 60 mg/ml" }, { "determination": "Bacterial endotoxins", "method": "Kinetic chromogenic LAL, USP <85>", "result": "< 0.05 EU/mg (< 0.55 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": "Microbial enumeration", "method": "Plate method, USP <61> and <62>", "result": "TAMC < 10 CFU/g, TYMC < 10 CFU/g; E. coli, Salmonella, S. aureus and P. 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 45 ppm; N,N-dimethylformamide, methanol, dichloromethane, diethyl ether, diisopropyl 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", "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-Asp 0.12 %, D-Glu 0.05 %, D-Ala < 0.05 %; Gly achiral; sum of D-forms 0.19 %", "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, DSIP, pinealon, 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": "10 mg", "labelledMg": 10, "fillMg": 10.95, "contentPercent": 84.14 }, "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-EPI-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" } }