Analīzes sertifikāts: Cagrilintide, partija ATCAG-05-2408-01
Cagrilintide, partija ATCAG-05-2408-01, pārbaudījusi neatkarīgā laboratorija Analyton Labs, sertifikāts AN-2026-00013 izsniegts 2026. gada 22. septembris: tīrība 99.23 ± 0.20 % (RP-HPLC), 4.88 mg peptīda uz flakonu, trifluoracetāts nav konstatēts, bakteriālie endotoksīni < 0.05 EU/mg, kopā 20 noteikšanas.
- Produkts
- Cagrilintide
- Partija
- ATCAG-05-2408-01
- Sertifikāta numurs
- AN-2026-00013
- Laboratorija
- Analyton Labs
- Izsniegšanas datums
- Paraugs
- Cagrilintide, lyophilised powder, vial labelled 5 mg
Rezultātu kopsavilkums, 20 noteikšanas
Metodes un rezultāti ir norādīti angļu valodā tieši tā, kā tos reģistrējusi laboratorija.
| Noteikšana | Metode | Rezultāts | Specifikācija |
|---|---|---|---|
| Appearance | Visual | White to off-white powder | White to off-white powder |
| Purity | RP-HPLC, C18, 214 nm (280 nm control trace), area % | 99.23 ± 0.20 % (k = 2) | >= 99.0 % |
| Related substances | RP-HPLC, 214 nm; LOD 0.01 %, LOQ 0.03 %, reporting threshold 0.05 % | Largest single impurity 0.34 % at RRT 1.03 (± 0.03 %); total impurities 0.77 %, i.e. 0.038 mg per vial | Single <= 0.5 %, total <= 1.0 % |
| Impurity profile | RP-HPLC with LC-HRMS assignment | RRT 0.82, 0.13 %, minus lipid (peptide without the lipid chain); RRT 0.91, 0.13 %, -97.05 Da (des-Pro); RRT 1.03, 0.34 %, +0.98 Da (deamidation of Gln/Asn, 6x in sequence); RRT 1.18, 0.17 %, twice the mass (dimer through a rearranged disulfide) | Peaks above 0.05 % reported (ICH Q3B) |
| Net peptide content | Assay | 88.33 ± 1.2 % w/w (k = 2) | >= 80.0 % |
| Fill weight | Gravimetric | 5.52 ± 0.05 mg | Labelled 5 mg |
| Peptide per vial | Calculated from fill weight and net peptide content | 4.88 mg per vial labelled 5 mg, i.e. 97.5 % of label | 95 to 105 % of label |
| Vial-to-vial consistency | Gravimetric, two vials of the batch | 5.52 and 5.66 mg, difference 2.5 %; purity of both within 0.1 % | <= 5 % |
| Counter-ion content | Ion chromatography, suppressed conductivity | Acetate 6.51 % w/w (± 0.39 %), i.e. 0.36 mg per vial | <= 8.0 % |
| Trifluoroacetate | Ion chromatography, LOQ 20 ppm | Not detected | <= 1000 ppm |
| Water content | Coulometric Karl Fischer, USP <921> | 4.83 ± 0.24 % w/w (k = 2), i.e. 0.27 mg per vial | <= 8.0 % |
| Mass balance | Peptide + counter-ion + water | 88.33 + 6.51 + 4.83 = 99.67 % (± 1.3 %) | Close to 100 % |
| pH | Potentiometric, 5 mg/ml in water | 5.2 | 4.4 to 6.0 |
| Solubility | Visual, 5 mg/ml and 1 mg/ml | >= 5 mg/ml in water and in bacteriostatic water; clear, colourless, free of particles within 30 s. Lipidated peptide: dissolve at pH 7.5, opalescent below pH 6 | Clear solution |
| Bacterial endotoxins | Kinetic chromogenic LAL, USP <85> | < 0.05 EU/mg (< 0.28 EU per vial) | <= 10 EU/mg |
| Sterility | Membrane filtration, USP <71>; fluid thioglycollate 30 to 35 °C and soya bean casein digest 20 to 25 °C | No growth after 14 days, 2 vials | No growth |
| Residual solvents | Headspace GC, USP <467> | Acetonitrile 122 ppm; methanol, dichloromethane and N,N-dimethylformamide not detected | ICH Q3C: acetonitrile <= 410, methanol <= 3000, dichloromethane <= 600, DMF <= 880 ppm |
| Elemental impurities | ICP-MS after microwave digestion (HNO3/H2O2), USP <233> | Cd, Pb, As, Hg < 0.05 µg/g; Co, V, Ni < 0.10 µg/g, all below LOQ | ICH Q3D(R2) Class 1 and 2A, parenteral PDE |
| Chiral purity (D-amino acids) | Acid hydrolysis (6 M DCl in D2O, 110 °C, 24 h), Marfey's derivatisation (FDAA), LC-MS | D-Cys 0.10 %, D-His 0.10 %, D-Ser 0.08 %, D-Phe 0.06 %, D-Asn 0.05 %, D-Thr 0.05 %, D-Gln 0.05 %, D-Glu 0.05 %, others < 0.05 %; Gly achiral; sum of D-forms 0.68 % | Each D-amino acid <= 0.2 %, sum of D-forms <= 0.5 % |
| Compound screening | LC-HRMS full scan, m/z 100 to 2000, against library: fentanyl and analogues, retatrutide, semaglutide, pramlintide, protected intermediates (tBu, Boc, Trt, Pbf, Fmoc), free amino acids | None detected above 0.05 % area | No foreign compound above 0.05 % area |
Faila SHA-256: 9718e6f7dddf411e8d6a665dc6607c71f0496e862b44bdbd10b299d5c41c89a9
Pētniecības materiāls. Sertifikāts apraksta partijas īpašības, nevis tās piemērotību lietošanai cilvēkiem vai dzīvniekiem.
