{ "@context": "https://molequa.com/coa/", "generatedAt": "2026-09-23", "reportNo": "AN-2026-00007", "key": "5FCQEGJY4E", "issued": "2026-09-22", "status": "issued", "sample": "Selank, lyophilised powder, vial labelled 10 mg", "batch": "ATSEL-10-2507-01", "batchSlug": "atsel-10-2507-01", "matrix": "Research peptide", "slug": "selank", "laboratory": { "name": "Analyton Labs", "url": "https://analyton.com/" }, "pdf": "https://molequa.com/coa/selank.pdf", "json": "https://molequa.com/coa/selank.json", "sha256": "e047461ff15b25ea94d41a3aacdc617e4c69f9d2ca334e83e63df4e9fa9cbb01", "verify": "https://analyton.com/verify/AN-2026-00007-5FCQEGJY4E/", "pages": { "sk": "https://molequa.com/sk/coa/selank/atsel-10-2507-01/", "cs": "https://molequa.com/cz/coa/selank/atsel-10-2507-01/", "en": "https://molequa.com/en/coa/selank/atsel-10-2507-01/", "hu": "https://molequa.com/hu/coa/selank/atsel-10-2507-01/", "pl": "https://molequa.com/pl/coa/selank/atsel-10-2507-01/", "nl": "https://molequa.com/nl/coa/selank/atsel-10-2507-01/", "ro": "https://molequa.com/ro/coa/selank/atsel-10-2507-01/", "de": "https://molequa.com/de/coa/selank/atsel-10-2507-01/", "at": "https://molequa.com/at/coa/selank/atsel-10-2507-01/", "es": "https://molequa.com/es/coa/selank/atsel-10-2507-01/", "bg": "https://molequa.com/bg/coa/selank/atsel-10-2507-01/", "fr": "https://molequa.com/fr/coa/selank/atsel-10-2507-01/", "fr-be": "https://molequa.com/fr-be/coa/selank/atsel-10-2507-01/", "nl-be": "https://molequa.com/nl-be/coa/selank/atsel-10-2507-01/", "pt": "https://molequa.com/pt/coa/selank/atsel-10-2507-01/" }, "product": { "sk": "https://molequa.com/sk/peptidy/selank/", "cs": "https://molequa.com/cz/peptidy/selank/", "en": "https://molequa.com/en/peptidy/selank/", "hu": "https://molequa.com/hu/peptidy/selank/", "pl": "https://molequa.com/pl/peptidy/selank/", "nl": "https://molequa.com/nl/peptidy/selank/", "ro": "https://molequa.com/ro/peptidy/selank/", "de": "https://molequa.com/de/peptide/selank/", "at": "https://molequa.com/at/peptide/selank/", "es": "https://molequa.com/es/peptidos/selank/", "bg": "https://molequa.com/bg/peptidi/selank/", "fr": "https://molequa.com/fr/peptides/selank/", "fr-be": "https://molequa.com/fr-be/peptides/selank/", "nl-be": "https://molequa.com/nl-be/peptidy/selank/", "pt": "https://molequa.com/pt/peptidos/selank/" }, "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": "99.07 ± 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 0.52 % at RRT 0.90 (± 0.03 %); total impurities 0.93 %, i.e. 0.092 mg per vial", "spec": "Single <= 1.0 %, total <= 2.0 %" }, { "determination": "Impurity profile", "method": "RP-HPLC with LC-HRMS assignment", "result": "RRT 0.90, 0.52 %, -97.05 Da (des-Pro); RRT 0.94, 0.41 %, truncated sequence (des-Arg)", "spec": "Peaks above 0.05 % reported (ICH Q3B)" }, { "determination": "Net peptide content", "method": "Assay", "result": "87.93 ± 1.2 % w/w (k = 2)", "spec": "" }, { "determination": "Fill weight", "method": "Gravimetric", "result": "11.22 ± 0.05 mg", "spec": "Labelled 10 mg" }, { "determination": "Peptide per vial", "method": "Calculated from fill weight and net peptide content", "result": "9.87 mg per vial labelled 10 mg, i.e. 98.7 % of label", "spec": "95 to 105 % of label" }, { "determination": "Vial-to-vial consistency", "method": "Gravimetric, two vials of the batch", "result": "11.22 and 11.57 mg, difference 3.1 %", "spec": "<= 5 %" }, { "determination": "Counter-ion content", "method": "Ion chromatography, suppressed conductivity", "result": "Acetate 7.71 % w/w (± 0.46 %), i.e. 0.87 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": "1.93 ± 0.10 % w/w (k = 2), i.e. 0.22 mg per vial", "spec": "", "kind": "water" }, { "determination": "Mass balance", "method": "Peptide + counter-ion + water", "result": "87.93 + 7.71 + 1.93 = 97.57 % (± 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, 10 mg/ml and 1 mg/ml", "result": ">= 10 mg/ml in water and in bacteriostatic water; clear, colourless, free of particles within 30 s", "spec": "Clear solution" }, { "determination": "Bacterial endotoxins", "method": "Bacterial endotoxins test (LAL), USP <85>, limit test", "result": "< 10 EU/mg (limit test at the specification limit)", "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-Thr 0.05 %, others < 0.05 %; Gly achiral; sum of D-forms 0.11 %", "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, Semax, 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": 11.22, "contentPercent": 87.93 }, "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-SEL-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" } }