Analitikai tanúsítvány: Semax, ATSMX-10-2508-01 tétel
Semax, ATSMX-10-2508-01 tétel, a független Analyton Labs laboratórium által vizsgálva, AN-2026-00009 tanúsítvány kiállítva 2026. szeptember 22.: tisztaság 99.77 ± 0.20 % RP-HPLC módszerrel, 11.50 mg peptid fiolánként, trifluor-acetát nem mutatható ki, bakteriális endotoxinok < 0.05 EU/mg, összesen 21 meghatározás.
- Termék
- Semax
- Tétel
- ATSMX-10-2508-01
- Tanúsítvány száma
- AN-2026-00009
- Laboratórium
- Analyton Labs
- Kiállítva
- Minta
- Semax, lyophilised powder, vial labelled 10 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 % | 99.77 ± 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 0.23 % at RRT 0.88 (± 0.03 %); total impurities 0.23 %, i.e. 0.026 mg per vial | Single <= 1.0 %, total <= 2.0 % |
| Impurity profile | RP-HPLC with LC-HRMS assignment | RRT 0.88, 0.23 %, +16 Da (Met sulfoxide) | Peaks above 0.05 % reported (ICH Q3B) |
| Net peptide content | Assay | 95.59 ± 1.2 % w/w (k = 2) | |
| Fill weight | Gravimetric | 12.03 ± 0.05 mg | Labelled 10 mg |
| Peptide per vial | Calculated from fill weight and net peptide content | 11.50 mg per vial labelled 10 mg, i.e. 115.0 % of label | 95 to 105 % of label |
| Vial-to-vial consistency | Gravimetric, two vials of the batch | 12.03 and 12.33 mg, difference 2.5 %; purity of both within 0.1 % | <= 5 % |
| Counter-ion content | Ion chromatography, suppressed conductivity | Acetate 1.32 % w/w (± 0.08 %), i.e. 0.16 mg per vial | <= 15.0 % |
| Trifluoroacetate | Ion chromatography, LOQ 20 ppm | Not detected | <= 0.5 % |
| Water content | Coulometric Karl Fischer, USP <921> | 2.86 ± 0.14 % w/w (k = 2), i.e. 0.34 mg per vial | <= 8.0 % |
| Mass balance | Peptide + counter-ion + water | 95.59 + 1.32 + 2.86 = 99.77 % (± 1.3 %) | Close to 100 % |
| 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 (< 0.60 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-His 0.10 %, D-Phe 0.06 %, D-Glu 0.05 %, others < 0.05 %; Gly achiral; sum of D-forms 0.25 % | 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, Selank, protected intermediates (tBu, Boc, Trt, Pbf, Fmoc), free amino acids | None detected above 0.05 % area | No foreign compound above 0.05 % area |
Tanúsítvány megtekintése Tanúsítvány PDF letöltése Adatok JSON formában Ellenőrzés a laboratóriumnál
A fájl SHA-256 értéke: 6d19722259f8b2b39b2a551961d7da18fffde9c9e0d71f6744115571a5049868
Kutatási anyag. A tanúsítvány a tétel tulajdonságait írja le, nem az emberi vagy állati felhasználásra való alkalmasságot.
