{
  "@context": "https://molequa.com/coa/",
  "generatedAt": "2026-09-23",
  "reportNo": "AN-2026-00009",
  "key": "CPDD9YWG23",
  "issued": "2026-09-22",
  "status": "issued",
  "sample": "Semax, lyophilised powder, vial labelled 10 mg",
  "batch": "ATSMX-10-2508-01",
  "batchSlug": "atsmx-10-2508-01",
  "matrix": "Research peptide",
  "slug": "semax",
  "laboratory": {
    "name": "Analyton Labs",
    "url": "https://analyton.com/"
  },
  "pdf": "https://molequa.com/coa/semax.pdf",
  "json": "https://molequa.com/coa/semax.json",
  "sha256": "6d19722259f8b2b39b2a551961d7da18fffde9c9e0d71f6744115571a5049868",
  "verify": "https://analyton.com/verify/AN-2026-00009-CPDD9YWG23/",
  "pages": {
    "sk": "https://molequa.com/sk/coa/semax/atsmx-10-2508-01/",
    "cs": "https://molequa.com/cz/coa/semax/atsmx-10-2508-01/",
    "en": "https://molequa.com/en/coa/semax/atsmx-10-2508-01/",
    "hu": "https://molequa.com/hu/coa/semax/atsmx-10-2508-01/",
    "pl": "https://molequa.com/pl/coa/semax/atsmx-10-2508-01/",
    "nl": "https://molequa.com/nl/coa/semax/atsmx-10-2508-01/",
    "ro": "https://molequa.com/ro/coa/semax/atsmx-10-2508-01/",
    "de": "https://molequa.com/de/coa/semax/atsmx-10-2508-01/",
    "at": "https://molequa.com/at/coa/semax/atsmx-10-2508-01/",
    "es": "https://molequa.com/es/coa/semax/atsmx-10-2508-01/",
    "bg": "https://molequa.com/bg/coa/semax/atsmx-10-2508-01/",
    "fr": "https://molequa.com/fr/coa/semax/atsmx-10-2508-01/",
    "fr-be": "https://molequa.com/fr-be/coa/semax/atsmx-10-2508-01/",
    "nl-be": "https://molequa.com/nl-be/coa/semax/atsmx-10-2508-01/",
    "pt": "https://molequa.com/pt/coa/semax/atsmx-10-2508-01/"
  },
  "product": {
    "sk": "https://molequa.com/sk/peptidy/semax/",
    "cs": "https://molequa.com/cz/peptidy/semax/",
    "en": "https://molequa.com/en/peptidy/semax/",
    "hu": "https://molequa.com/hu/peptidy/semax/",
    "pl": "https://molequa.com/pl/peptidy/semax/",
    "nl": "https://molequa.com/nl/peptidy/semax/",
    "ro": "https://molequa.com/ro/peptidy/semax/",
    "de": "https://molequa.com/de/peptide/semax/",
    "at": "https://molequa.com/at/peptide/semax/",
    "es": "https://molequa.com/es/peptidos/semax/",
    "bg": "https://molequa.com/bg/peptidi/semax/",
    "fr": "https://molequa.com/fr/peptides/semax/",
    "fr-be": "https://molequa.com/fr-be/peptides/semax/",
    "nl-be": "https://molequa.com/nl-be/peptidy/semax/",
    "pt": "https://molequa.com/pt/peptidos/semax/"
  },
  "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": "99.77 ± 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 0.23 % at RRT 0.88 (± 0.03 %); total impurities 0.23 %, i.e. 0.026 mg per vial",
      "spec": "Single <= 1.0 %, total <= 2.0 %"
    },
    {
      "determination": "Impurity profile",
      "method": "RP-HPLC with LC-HRMS assignment",
      "result": "RRT 0.88, 0.23 %, +16 Da (Met sulfoxide)",
      "spec": "Peaks above 0.05 % reported (ICH Q3B)"
    },
    {
      "determination": "Net peptide content",
      "method": "Assay",
      "result": "95.59 ± 1.2 % w/w (k = 2)",
      "spec": ""
    },
    {
      "determination": "Fill weight",
      "method": "Gravimetric",
      "result": "12.03 ± 0.05 mg",
      "spec": "Labelled 10 mg"
    },
    {
      "determination": "Peptide per vial",
      "method": "Calculated from fill weight and net peptide content",
      "result": "11.50 mg per vial labelled 10 mg, i.e. 115.0 % of label",
      "spec": "95 to 105 % of label"
    },
    {
      "determination": "Vial-to-vial consistency",
      "method": "Gravimetric, two vials of the batch",
      "result": "12.03 and 12.33 mg, difference 2.5 %; purity of both within 0.1 %",
      "spec": "<= 5 %"
    },
    {
      "determination": "Counter-ion content",
      "method": "Ion chromatography, suppressed conductivity",
      "result": "Acetate 1.32 % w/w (± 0.08 %), i.e. 0.16 mg per vial",
      "spec": "<= 15.0 %"
    },
    {
      "determination": "Trifluoroacetate",
      "method": "Ion chromatography, LOQ 20 ppm",
      "result": "Not detected",
      "spec": "<= 0.5 %"
    },
    {
      "determination": "Water content",
      "method": "Coulometric Karl Fischer, USP <921>",
      "result": "2.86 ± 0.14 % w/w (k = 2), i.e. 0.34 mg per vial",
      "spec": "<= 8.0 %",
      "kind": "water"
    },
    {
      "determination": "Mass balance",
      "method": "Peptide + counter-ion + water",
      "result": "95.59 + 1.32 + 2.86 = 99.77 % (± 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": "Kinetic chromogenic LAL, USP <85>",
      "result": "< 0.05 EU/mg (< 0.60 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-His 0.10 %, D-Phe 0.06 %, D-Glu 0.05 %, others < 0.05 %; Gly achiral; sum of D-forms 0.25 %",
      "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, Selank, 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": 12.03,
    "contentPercent": 95.59
  },
  "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-SEM-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"
  }
}