Certificat de analiză: BPC-157, lot ATBPC-10-2512-01
BPC-157, lot ATBPC-10-2512-01, testat de laboratorul independent Analyton Labs, certificat AN-2026-00002 emis la 22 septembrie 2026: puritate 99.60 ± 0.20 % prin RP-HPLC, 8.87 mg peptidă per flacon, trifluoroacetat nedetectat, endotoxine bacteriene < 0.05 EU/mg, în total 20 determinări.
- Produs
- BPC-157
- Lot
- ATBPC-10-2512-01
- Numărul certificatului
- AN-2026-00002
- Laborator
- Analyton Labs
- Emis
- Probă
- BPC-157, lyophilised powder, vial labelled 10 mg
Rezumatul rezultatelor, 20 determinări
Metodele și rezultatele sunt redate în engleză, exact așa cum le-a consemnat laboratorul.
| Determinare | Metodă | Rezultat | Specificație |
|---|---|---|---|
| Appearance | Visual | White to off-white powder | White to off-white powder |
| Purity | RP-HPLC, C18, 214 nm, area % | 99.60 ± 0.20 % (k = 2) | >= 97.0 % |
| Related substances | RP-HPLC, 214 nm; LOD 0.01 %, LOQ 0.03 %, reporting threshold 0.05 % | Largest single impurity 0.22 % at RRT 0.96 (± 0.03 %); total impurities 0.40 %, i.e. 0.035 mg per vial | Single <= 1.0 %, total <= 3.0 % |
| Impurity profile | RP-HPLC with LC-HRMS assignment | RRT 0.91, 0.10 %, -97.05 Da (des-Pro); RRT 0.96, 0.22 %, same mass (isoAsp at Asp10 or Asp11); RRT 1.05, 0.08 %, -18.01 Da (succinimide at Asp-Asp) | Peaks above 0.05 % reported (ICH Q3B) |
| Net peptide content | Assay | 86.74 ± 1.2 % w/w (k = 2) | |
| Fill weight | Gravimetric | 10.23 ± 0.05 mg | Labelled 10 mg |
| Peptide per vial | Calculated from fill weight and net peptide content | 8.87 mg per vial labelled 10 mg, i.e. 88.7 % of label | 95 to 105 % of label |
| Vial-to-vial consistency | Gravimetric, two vials of the batch | 10.23 and 10.63 mg, difference 3.8 % | <= 5 % |
| Counter-ion content | Ion chromatography (cation) | L-arginine 7.30 % w/w (± 0.40 %), i.e. 0.75 mg per vial | <= 10.0 % |
| Trifluoroacetate | Ion chromatography, LOQ 20 ppm | Not detected | <= 0.5 % |
| Water content | Coulometric Karl Fischer, USP <921> | 5.61 ± 0.25 % w/w (k = 2), i.e. 0.57 mg per vial | <= 8.0 % |
| Mass balance | Peptide + counter-ion + water | 86.74 + 7.30 + 5.61 = 99.65 % (± 1.3 %) | Close to 100 % |
| pH | Potentiometric, 10 mg/ml in water | 6.4 | 5.9 to 6.5 |
| Solubility | Visual, 10 mg/ml and 1 mg/ml | >= 10 mg/ml in water and in bacteriostatic water (0.9 % benzyl alcohol); clear, colourless, free of particles within 30 s with gentle swirling | Clear solution |
| Bacterial endotoxins | Kinetic chromogenic LAL, USP <85> | < 0.05 EU/mg (< 0.51 EU per vial) | <= 10 EU/mg |
| Sterility | USP <71>; fluid thioglycollate 30 to 35 °C and soya bean casein digest 20 to 25 °C | No growth | No growth |
| Microbial enumeration | Membrane filtration, USP <61> and <62>; TSA 30 to 35 °C 3 days, SDA 20 to 25 °C 5 days | 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 |
| 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 0.15 %, 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, TB-500, GHK-Cu, KPV, semaglutide, free L-arginine, protected intermediates (tBu, Boc, Trt, Pbf, Fmoc), free amino acids | None detected above 0.05 % area; free L-arginine consistent with the declared salt | No foreign compound above 0.05 % area |
SHA-256 al fișierului: 21156466021826a8b6ebcc6d75019767f3ca1abfbc7a294f3f2cb6958d634ad8
Material de cercetare. Certificatul descrie proprietățile lotului, nu potrivirea pentru vreo utilizare la oameni sau animale.
