{ "@context": "https://molequa.com/coa/", "generatedAt": "2026-10-16", "reportNo": "AN-2026-00016", "key": "6QKAF6P4D8", "issued": "2026-10-15", "status": "issued", "sample": "Pinealon (Glu-Asp-Arg), lyophilised powder, vial labelled 20 mg", "batch": "ATPIN-20-2609-01", "batchSlug": "atpin-20-2609-01", "matrix": "Research peptide", "slug": "pinealon", "laboratory": { "name": "Analyton Labs", "url": "https://analyton.com/" }, "pdf": "https://molequa.com/coa/pinealon.pdf", "json": "https://molequa.com/coa/pinealon.json", "sha256": "7583f2b6609f98ab631f40f983f93865520111159ae0c030cb4edd5be752535d", "verify": "https://analyton.com/verify/AN-2026-00016-6QKAF6P4D8/", "pages": { "sk": "https://molequa.com/sk/coa/pinealon/atpin-20-2609-01/", "cs": "https://molequa.com/cz/coa/pinealon/atpin-20-2609-01/", "en": "https://molequa.com/en/coa/pinealon/atpin-20-2609-01/", "hu": "https://molequa.com/hu/coa/pinealon/atpin-20-2609-01/", "pl": "https://molequa.com/pl/coa/pinealon/atpin-20-2609-01/", "nl": "https://molequa.com/nl/coa/pinealon/atpin-20-2609-01/", "ro": "https://molequa.com/ro/coa/pinealon/atpin-20-2609-01/", "de": "https://molequa.com/de/coa/pinealon/atpin-20-2609-01/", "at": "https://molequa.com/at/coa/pinealon/atpin-20-2609-01/", "es": "https://molequa.com/es/coa/pinealon/atpin-20-2609-01/", "bg": "https://molequa.com/bg/coa/pinealon/atpin-20-2609-01/", "fr": "https://molequa.com/fr/coa/pinealon/atpin-20-2609-01/", "fr-be": "https://molequa.com/fr-be/coa/pinealon/atpin-20-2609-01/", "nl-be": "https://molequa.com/nl-be/coa/pinealon/atpin-20-2609-01/", "pt": "https://molequa.com/pt/coa/pinealon/atpin-20-2609-01/", "it": "https://molequa.com/it/coa/pinealon/atpin-20-2609-01/", "sl": "https://molequa.com/sl/coa/pinealon/atpin-20-2609-01/", "da": "https://molequa.com/da/coa/pinealon/atpin-20-2609-01/" }, "product": null, "results": [ { "determination": "Appearance", "method": "Visual", "result": "White to off-white lyophilised powder, free of visible particles", "spec": "White to off-white powder" }, { "determination": "Identity", "method": "LC-HRMS, ESI+ and ESI-, USP <621> principles", "result": "[M+H]+ 419.1886, deviation 0.2 ppm; [M+2H]2+ 210.098; [M-H]- 417.1744, deviation 1.2 ppm; MS/MS y1 (Arg) 175.119, b2 (Glu-Asp) 245.077, y2 (Asp-Arg) 290.146: residue order Glu-Asp-Arg confirmed", "spec": "Theoretical monoisotopic 418.1812 Da from C15H26N6O8; [M+H]+ 419.1885, [M-H]- 417.1739; deviation <= 10 ppm", "kind": "identity" }, { "determination": "Purity", "method": "RP-HPLC, C18 polar-endcapped, 214 nm, area %, 0.1 % TFA", "result": "99.62 ± 0.15 % (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 0.11 % at RRT 0.94 (± 0.02 %); total impurities 0.38 %, i.e. 0.076 mg per vial", "spec": "Single <= 0.5 %, total <= 1.0 %" }, { "determination": "Impurity profile", "method": "RP-HPLC with LC-HRMS assignment", "result": "RRT 0.86, 0.10 %, -129.04 Da (des-Glu, Asp-Arg); RRT 0.94, 0.11 %, same mass (beta-Asp2 isomer, isoAsp); RRT 1.07, 0.09 %, -18.01 Da (pyroGlu1-Asp-Arg, N-terminal cyclisation); RRT 1.15, 0.08 %, +129.04 Da (Glu-Glu-Asp-Arg, double Glu coupling)", "spec": "Peaks above 0.05 % reported (ICH Q3B)" }, { "determination": "Net peptide content", "method": "Amino acid analysis after acid hydrolysis (AAA)", "result": "81.50 ± 1.2 % w/w (k = 2); a tripeptide with Arg binds more counter-ion and water per unit mass than a long peptide, hence the lower limit", "spec": ">= 75 %" }, { "determination": "Fill weight", "method": "Gravimetric, two vials", "result": "24.3 ± 0.05 mg (second vial 24.6 mg, difference 1.2 %)", "spec": "Labelled 20 mg" }, { "determination": "Peptide per vial", "method": "Calculated from fill weight and net peptide content", "result": "19.80 mg per vial labelled 20 mg, i.e. 99.0 % of label", "spec": "95 to 105 % of label" }, { "determination": "Counter-ion content", "method": "Ion chromatography (anion), suppressed conductivity", "result": "Acetate 12.30 % w/w (± 0.6 %), i.e. 3.0 mg per vial, 1.05 mol per mol at two basic sites (Glu1 N-terminus and Arg3 guanidine); trifluoroacetate < 20 ppm (LOQ 20 ppm); chloride and phosphate < 20 ppm", "spec": "Acetate <= 15 %; trifluoroacetate <= 1000 ppm", "kind": "counterion" }, { "determination": "Water content", "method": "Coulometric Karl Fischer, USP <921>", "result": "5.60 ± 0.28 % w/w (k = 2), i.e. 1.4 mg per vial", "spec": "<= 8.0 %", "kind": "water" }, { "determination": "Mass balance", "method": "Peptide + counter-ion + water", "result": "81.50 + 12.30 + 5.60 = 99.40 % (± 1.4 %)", "spec": "Close to 100 %" }, { "determination": "pH", "method": "Potentiometric, 20 mg/ml in water", "result": "4.9 (acidic peptide as acetate)", "spec": "4.0 to 5.5" }, { "determination": "Solubility", "method": "Visual, 20 mg/ml and 1 mg/ml", "result": ">= 20 mg/ml in water and in bacteriostatic water; clear, colourless, free of particles within 15 s", "spec": "Clear solution" }, { "determination": "Bacterial endotoxins", "method": "Kinetic chromogenic LAL, USP <85>", "result": "< 0.05 EU/mg (< 1.0 EU per vial; LOQ 0.005 EU/mg)", "spec": "<= 0.5 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 22 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 per 20 mg daily: Cd 100, Pb 250, As 750, Hg 150, Co 250, V 500, Ni 1000 µg/g", "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 0.10 %, D-Glu 0.09 %, D-Arg 0.04 %; sum of D-forms 0.23 %. All three residues are chiral; an enantiomer has the same mass and the same achiral retention time, so this determination is decisive for a tripeptide", "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, Epithalon (AEDG), Vilon (KE), Thymogen (EW), Semax, Selank, protected intermediates (tBu on Glu/Asp, Pbf on Arg, Fmoc, Boc) and free amino acids (Glu, Asp, Arg): none above 0.05 % of area", "spec": "Nothing above 0.05 %", "kind": "screen" } ], "delivery": { "labelled": "20 mg", "labelledMg": 20, "fillMg": 24.3, "contentPercent": 81.5 }, "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-EDR-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; control sample from the previous batch within 0.2 % of its value" } }