{ "@context": "https://molequa.com/coa/", "generatedAt": "2026-10-16", "reportNo": "AN-2026-00015", "key": "K5CK39G3ZM", "issued": "2026-08-28", "status": "issued", "sample": "GHK-Cu (copper tripeptide-1), powder, vial labelled 100 mg", "batch": "ATGHK-100-2608-01", "batchSlug": "atghk-100-2608-01", "matrix": "Research peptide, copper(II) complex", "slug": "ghk-cu", "laboratory": { "name": "Analyton Labs", "url": "https://analyton.com/" }, "pdf": "https://molequa.com/coa/ghk-cu.pdf", "json": "https://molequa.com/coa/ghk-cu.json", "sha256": "091a576f8fafa22fc73da6b105f7754c48252fcc4fc8bbf9b0d8af9541d1e07a", "verify": "https://analyton.com/verify/AN-2026-00015-K5CK39G3ZM/", "pages": { "sk": "https://molequa.com/sk/coa/ghk-cu/atghk-100-2608-01/", "cs": "https://molequa.com/cz/coa/ghk-cu/atghk-100-2608-01/", "en": "https://molequa.com/en/coa/ghk-cu/atghk-100-2608-01/", "hu": "https://molequa.com/hu/coa/ghk-cu/atghk-100-2608-01/", "pl": "https://molequa.com/pl/coa/ghk-cu/atghk-100-2608-01/", "nl": "https://molequa.com/nl/coa/ghk-cu/atghk-100-2608-01/", "ro": "https://molequa.com/ro/coa/ghk-cu/atghk-100-2608-01/", "de": "https://molequa.com/de/coa/ghk-cu/atghk-100-2608-01/", "at": "https://molequa.com/at/coa/ghk-cu/atghk-100-2608-01/", "es": "https://molequa.com/es/coa/ghk-cu/atghk-100-2608-01/", "bg": "https://molequa.com/bg/coa/ghk-cu/atghk-100-2608-01/", "fr": "https://molequa.com/fr/coa/ghk-cu/atghk-100-2608-01/", "fr-be": "https://molequa.com/fr-be/coa/ghk-cu/atghk-100-2608-01/", "nl-be": "https://molequa.com/nl-be/coa/ghk-cu/atghk-100-2608-01/", "pt": "https://molequa.com/pt/coa/ghk-cu/atghk-100-2608-01/", "it": "https://molequa.com/it/coa/ghk-cu/atghk-100-2608-01/", "sl": "https://molequa.com/sl/coa/ghk-cu/atghk-100-2608-01/", "da": "https://molequa.com/da/coa/ghk-cu/atghk-100-2608-01/" }, "product": { "sk": "https://molequa.com/sk/peptidy/ghk-cu/", "cs": "https://molequa.com/cz/peptidy/ghk-cu/", "en": "https://molequa.com/en/peptidy/ghk-cu/", "hu": "https://molequa.com/hu/peptidy/ghk-cu/", "pl": "https://molequa.com/pl/peptidy/ghk-cu/", "nl": "https://molequa.com/nl/peptidy/ghk-cu/", "ro": "https://molequa.com/ro/peptidy/ghk-cu/", "de": "https://molequa.com/de/peptide/ghk-cu/", "at": "https://molequa.com/at/peptide/ghk-cu/", "es": "https://molequa.com/es/peptidos/ghk-cu/", "bg": "https://molequa.com/bg/peptidi/ghk-cu/", "fr": "https://molequa.com/fr/peptides/ghk-cu/", "fr-be": "https://molequa.com/fr-be/peptides/ghk-cu/", "nl-be": "https://molequa.com/nl-be/peptidy/ghk-cu/", "pt": "https://molequa.com/pt/peptidos/ghk-cu/", "it": "https://molequa.com/it/peptidi/ghk-cu/", "sl": "https://molequa.com/sl/peptidi/ghk-cu/", "da": "https://molequa.com/da/peptider/ghk-cu/" }, "results": [ { "determination": "Appearance", "method": "Visual", "result": "Blue to blue-violet powder, homogeneous, free of white particles (white particles would be copper-free GHK)", "spec": "Blue to blue-violet powder" }, { "determination": "Identity", "method": "LC-HRMS (ESI+), two conditions, USP <621> principles", "result": "In 10 mM ammonium acetate pH 6.5 the complex is seen: m/z 402.1073 [GHK-2H+Cu+H]+, deviation 0.5 ppm, with the 63Cu/65Cu isotope pair 402.107/404.105 at 69:31; in 0.1 % formic acid the complex dissociates and the free ligand is seen: [M+H]+ 341.1932, deviation 0.0 ppm; MS/MS y2 (His-Lys) 284.172, b2 (Gly-His) 195.088; ESI- [M-H]- 339.179", "spec": "Theoretical monoisotopic 401.0999 Da from C14H22CuN6O4 ([M+H]+ 402.1071) and 340.1859 Da for GHK from C14H24N6O4 ([M+H]+ 341.1932); difference 60.914 Da = Cu - 2H; deviation <= 10 ppm", "kind": "identity" }, { "determination": "Purity", "method": "RP-HPLC, C18, 214 nm, area %, 0.05 % TFA (the complex dissociates; the GHK ligand is measured)", "result": "99.58 ± 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 0.18 % at RRT 1.08 (± 0.02 %); total impurities 0.42 %, i.e. 0.42 mg per vial; free uncomplexed GHK 1.8 % of area at pH 6.5 (ammonium acetate, 214 nm)", "spec": "Single <= 0.5 %, total <= 1.0 %; free GHK <= 5 %" }, { "determination": "Impurity profile", "method": "RP-HPLC with LC-HRMS assignment", "result": "RRT 0.91, 0.12 %, -57.02 Da (des-Gly, His-Lys); RRT 1.08, 0.18 %, +57.02 Da (Gly-Gly-His-Lys, double Gly coupling); RRT 1.19, 0.12 %, +16 Da (His oxidation, 2-oxo-His)", "spec": "Peaks above 0.05 % reported (ICH Q3B)" }, { "determination": "Complex content", "method": "Amino acid analysis after hydrolysis (GHK) and ICP-OES at 324.75 nm (Cu)", "result": "93.50 ± 1.4 % w/w GHK-Cu complex, from GHK 79.20 % w/w and Cu 14.80 ± 0.30 % w/w; molar ratio Cu : GHK = 1.00 (Cu is 15.81 % of the complex mass)", "spec": ">= 90 % w/w; ratio 0.95 to 1.05" }, { "determination": "Fill weight", "method": "Gravimetric, two vials", "result": "104.8 ± 0.05 mg (second vial 104.0 mg, difference 0.8 %)", "spec": "Labelled 100 mg" }, { "determination": "Peptide per vial", "method": "Calculated from fill weight and net peptide content", "result": "97.99 mg per vial labelled 100 mg, i.e. 98.0 % of label", "spec": "95 to 105 % of label" }, { "determination": "Complex composition per vial", "method": "Calculated from fill weight, complex content and purity", "result": "98.0 mg of GHK-Cu complex per vial (fill weight × complex content), of which main component 97.6 mg (× purity), GHK 82.5 mg and Cu 15.5 mg", "spec": "Report only" }, { "determination": "Counter-ion content", "method": "Ion chromatography (anion), suppressed conductivity; ICP-OES after SPE for free copper", "result": "Acetate 2.00 % w/w (± 0.15 %), 0.14 mol per mol of complex; trifluoroacetate < 20 ppm (LOQ 20 ppm); chloride, sulfate, phosphate < 20 ppm; free uncomplexed Cu2+ 0.10 % w/w", "spec": "Acetate <= 5.0 %; trifluoroacetate <= 1000 ppm; free Cu2+ <= 0.5 %", "kind": "counterion" }, { "determination": "Water content", "method": "Coulometric Karl Fischer, USP <921>, weighed in a dry atmosphere", "result": "4.00 ± 0.20 % w/w (k = 2), i.e. 4.2 mg per vial; hygroscopic powder", "spec": "<= 8.0 %", "kind": "water" }, { "determination": "Mass balance", "method": "Complex + counter-ion + water", "result": "93.50 + 2.00 + 4.00 = 99.50 % (± 1.5 %); remainder free Cu2+ 0.10 % and UV-silent residue", "spec": "Close to 100 %" }, { "determination": "pH", "method": "Potentiometric, 10 mg/ml in water, unadjusted", "result": "6.8 (below pH 5 the complex dissociates and the colour fades)", "spec": "6.0 to 7.5" }, { "determination": "Solubility and complex colour", "method": "Visual, 50 mg/ml and 1 mg/ml; UV-Vis", "result": ">= 50 mg/ml in water and in bacteriostatic water; clear blue-violet solution, free of particles within 30 s; λmax 525 nm (Cu(II) d-d band), A525 = 0.21 at 1 mg/ml in 1 cm, consistent with a 1 : 1 complex", "spec": "Clear coloured solution" }, { "determination": "Bacterial endotoxins", "method": "Kinetic chromogenic LAL, USP <85>, 1 in 100 dilution (Cu2+ inhibits the lysate; dilution validated)", "result": "< 0.05 EU/mg (< 5.0 EU per vial; LOQ 0.005 EU/mg)", "spec": "<= 0.2 EU/mg", "kind": "endotoxin" }, { "determination": "Sterility", "method": "Membrane filtration with rinsing (Cu2+ is antimicrobial; method suitability verified with inoculum), 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>, Cu2+ neutralised with thioglycollate; 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": "Ethanol 120 ppm (crystallisation of the complex); acetonitrile 25 ppm; N,N-dimethylformamide, methanol, dichloromethane, diethyl ether and piperidine each < 10 ppm (LOQ 10 ppm)", "spec": "ICH Q3C: ethanol <= 5000, acetonitrile <= 410, DMF <= 880, methanol <= 3000, dichloromethane <= 600 ppm", "kind": "solvents" }, { "determination": "Elemental impurities", "method": "ICP-MS after microwave digestion (HNO3/H2O2), USP <233>; copper is the active component and is not assessed as an impurity", "result": "Cd, Pb, As, Hg < 0.05 µg/g; Co, V < 0.10 µg/g; Ni 0.80 µg/g (companion element of copper salts); Zn 2.1 and Fe 3.5 µg/g for information", "spec": "ICH Q3D(R2) Class 1 and 2A, parenteral PDE per 100 mg daily: Cd 20, Pb 50, As 150, Hg 30, Co 50, V 100, Ni 200 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-His 0.18 %, D-Lys 0.06 %; Gly achiral; sum of D-forms 0.24 %. His racemises most readily during coupling, which is why D-His sits near the limit and is reported as a number", "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, AHK-Cu, palmitoyl-GHK, free GHK, KPV, Epithalon, protected intermediates (Boc, Trt on His, tBu, Fmoc) and free amino acids (Gly, His, Lys): none above 0.05 % of area", "spec": "Nothing above 0.05 %", "kind": "screen" } ], "delivery": { "labelled": "100 mg", "labelledMg": 100, "fillMg": 104.8, "contentPercent": 93.5 }, "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 0.002 %)", "referenceStandard": "In-house reference standard RS-GHK-01 (purity assigned against a primary GHK standard, copper by ICP-OES, stored at -20 °C in the dark) 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" } }