Analitikai tanúsítvány: DSIP, ATDSP-05-2505-01 tétel
DSIP, ATDSP-05-2505-01 tétel, a független Analyton Labs laboratórium által vizsgálva, AN-2026-00003 tanúsítvány kiállítva 2026. szeptember 22.: tisztaság 99.88 ± 0.20 % RP-HPLC módszerrel, 4.88 mg peptid fiolánként, trifluor-acetát < 20 ppm, bakteriális endotoxinok < 0.05 EU/mg, összesen 21 meghatározás.
- Termék
- DSIP
- Tétel
- ATDSP-05-2505-01
- Tanúsítvány száma
- AN-2026-00003
- Laboratórium
- Analyton Labs
- Kiállítva
- Minta
- DSIP, lyophilised powder, vial labelled 5 mg
Eredmények összefoglalása, 21 meghatározás
A módszerek és eredmények angolul szerepelnek, pontosan úgy, ahogy a laboratórium rögzítette.
| Meghatározás | Módszer | Eredmény | Specifikáció |
|---|---|---|---|
| Appearance | Visual | White to off-white powder | White to off-white powder |
| Purity | RP-HPLC, C18, 214 nm (280 nm control trace), area % | 99.88 ± 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 0.07 % at RRT 0.96 (± 0.03 %); total impurities 0.12 %, i.e. 0.006 mg per vial | Single <= 1.0 %, total <= 2.0 % |
| Impurity profile | RP-HPLC with LC-HRMS assignment | RRT 0.90, 0.05 %, +16/+32 Da (Trp oxidation: kynurenine, hydroxytryptophan); RRT 0.96, 0.07 %, same mass (isoAsp) | Peaks above 0.05 % reported (ICH Q3B) |
| Net peptide content | Assay | 93.88 ± 1.2 % w/w (k = 2) | |
| Fill weight | Gravimetric | 5.20 ± 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. 97.6 % of label | 95 to 105 % of label |
| Vial-to-vial consistency | Gravimetric, two vials of the batch | 5.20 and 5.33 mg, difference 2.5 %; purity of both within 0.1 % | <= 5 % |
| Counter-ion content | Ion chromatography | Sodium 0.90 % w/w (± 0.05 %), i.e. 0.05 mg per vial; acetate < 0.05 % | |
| Trifluoroacetate | Ion chromatography, LOQ 20 ppm | < 20 ppm; acetate, chloride and phosphate below LOQ | <= 1000 ppm |
| Water content | Coulometric Karl Fischer, USP <921> | 4.80 ± 0.24 % w/w (k = 2), i.e. 0.25 mg per vial | <= 8.0 % |
| Mass balance | Peptide + counter-ion + water | 93.88 + 0.90 + 4.80 = 99.58 % (± 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 to faintly yellow, free of particles within 30 s | Clear solution |
| Bacterial endotoxins | Kinetic chromogenic LAL, USP <85> | < 0.05 EU/mg (< 0.26 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-Ser 0.08 %, D-Glu 0.05 %, others < 0.05 %; Gly achiral; sum of D-forms 0.29 % | 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, Epithalon, Selank, Semax, protected intermediates (tBu, Boc, Trt, Pbf, Fmoc), free amino acids | None detected above 0.05 % area | No foreign compound above 0.05 % area |
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