Analīzes sertifikāts: Ipamorelin + CJC-1295, partija ATCJI-10-2509-01
Ipamorelin + CJC-1295, partija ATCJI-10-2509-01, pārbaudījusi neatkarīgā laboratorija Analyton Labs, sertifikāts AN-2026-00012 izsniegts 2026. gada 22. septembris: tīrība 99.25 ± 0.20 % (RP-HPLC), 85.03 ± 1.2 % peptīda uz flakonu, trifluoracetāts nav konstatēts, bakteriālie endotoksīni < 0.05 EU/mg, kopā 19 noteikšanas.
- Produkts
- Ipamorelin + CJC-1295
- Partija
- ATCJI-10-2509-01
- Sertifikāta numurs
- AN-2026-00012
- Laboratorija
- Analyton Labs
- Izsniegšanas datums
- Paraugs
- CJC-1295 no DAC + Ipamorelin, lyophilised powder, vial labelled 10 mg (5 mg + 5 mg)
Rezultātu kopsavilkums, 19 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 % | 99.25 ± 0.20 % (k = 2) | >= 98.0 % |
| Related substances | RP-HPLC, 214 nm; LOD 0.01 %, LOQ 0.03 %, reporting threshold 0.05 % | Largest single impurity 0.53 % at RRT 0.96 (± 0.03 %); total impurities 0.75 % | Single <= 1.0 %, total <= 2.0 % |
| Impurity profile | RP-HPLC with LC-HRMS assignment | RRT 0.96, 0.53 %, same mass (isoAsp, 2x Asp in sequence); RRT 1.03, 0.09 %, +0.98 Da (deamidation of Gln/Asn); RRT 1.06, 0.13 %, -18.01 Da (Asp succinimide) | Peaks above 0.05 % reported (ICH Q3B) |
| Net peptide content | Assay | 85.03 ± 1.2 % w/w (k = 2), CJC-1295 no DAC only | |
| Fill weight | Gravimetric | 10.40 ± 0.05 mg | Labelled 10 mg |
| Vial-to-vial consistency | Gravimetric, two vials of the batch | 10.40 and 10.66 mg, difference 2.5 %; purity of both within 0.1 % | <= 5 % |
| Counter-ion content | Ion chromatography, suppressed conductivity | Acetate 6.65 % w/w (± 0.40 %), CJC-1295 no DAC only | |
| Trifluoroacetate | Ion chromatography, LOQ 20 ppm | Not detected, CJC-1295 no DAC only | |
| Water content | Coulometric Karl Fischer, USP <921> | 7.67 ± 0.38 % w/w (k = 2), i.e. 0.80 mg per vial | |
| pH | Potentiometric, 10 mg/ml in water | 5.2 | 4.4 to 6.0 |
| Solubility | Visual, 10 mg/ml and 1 mg/ml | >= 10 mg/ml in water and in bacteriostatic water; clear, colourless, free of particles within 30 s | Clear solution |
| Bacterial endotoxins | Kinetic chromogenic LAL, USP <85> | < 0.05 EU/mg (< 0.52 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 |
| Microbial enumeration | Plate method, USP <61> and <62> | TAMC < 10 CFU/g, TYMC < 10 CFU/g; E. coli, Salmonella, S. aureus and P. aeruginosa absent in 1 g | TAMC <= 1000 CFU/g, TYMC <= 100 CFU/g, specified organisms absent |
| Residual solvents | Headspace GC, USP <467> | Acetonitrile 45 ppm; N,N-dimethylformamide, methanol, dichloromethane, diethyl ether, diisopropyl ether and piperidine each < 10 ppm (LOQ 10 ppm) | ICH Q3C: acetonitrile <= 410, DMF <= 880, methanol <= 3000, dichloromethane <= 600, ethers <= 5000 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-Asp 0.12 %, D-His 0.10 %, D-Ser 0.08 %, D-Phe 0.06 %, D-Tyr 0.05 %, D-Thr 0.05 %, D-Gln 0.05 %, others < 0.05 %; intended D-2-Nal, D-Phe, D-Ala >= 99.5 % D; Aib achiral; sum of D-forms 0.63 % | 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, CJC-1295 with DAC, GHRP-2, GHRP-6, sermorelin, 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: 84b6fd2eaf757e62f7aee3e86052c5430dddef3bde1fafc8ae667f4bc4787c16
Pētniecības materiāls. Sertifikāts apraksta partijas īpašības, nevis tās piemērotību lietošanai cilvēkiem vai dzīvniekiem.
