1.02836

L-Cystine

suitable for biopharmaceutical production FCC

• Sinonimo/i: L-Cystine, Cys
• Formula empirica (notazione di Hill): C₆H₁₂N₂O₄S₂
• Numero CAS: 56-89-3
• Peso molecolare: 240.30
• Numero MDL: MFCD00064228
• Codice UNSPSC: 12352209
• Numero indice EU: 200-296-3

Proprietà

• Conformità normativa: FCC
• Livello qualitativo: 300
• Stato: solid
• Punto di fusione: 261-262 °C (decomposition)
• Solubilità: insoluble 0.19 g/L
• Densità: 1.677 g/cm³ at 20 °C
• Densità bulk: 300 kg/m³
• applicazioni: pharma/biopharma processes
• Temperatura di conservazione: 2-30°C
• InChI: 1S/C6H12N2O4S2/c7-3(5(9)10)1-13-14-2-4(8)6(11)12/h3-4H,1-2,7-8H2,(H,9,10)(H,11,12)/t3-,4-/m0/s1; LEVWYRKDKASIDU-IMJSIDKUSA-N

Descrizione

Descrizione generale

Our SAFC^® portfolio of high-quality raw materials for use in biopharmaceutical processing withstands strict quality control procedures plus the documentation and expertise to help our customers meet requirements as defined by the M-Clarity Program.

M-Clarity Program

Our comprehensive portfolio of upstream process chemicals not only provides biopharmaceutical manufacturers with high-quality raw materials for production of classical and novel therapies, but also helps them get to market faster and simplify regulatory challenges. Trust us to deliver supply chain transparency and reliable sourcing around the globe, streamlining your product qualification with best-in-class regulatory support and service.

We offer a range of high quality critical raw materials plus the documentation and expertise to help our customers meet stringent regulatory requirements. Our SAFC^® portfolio of high-quality products withstands strict quality control procedures.

Risultati analitici

Assay (ex N, calc. on dried substance): 98.5 - 101.5 %
Identity (IR-spectrum): passes test
Appearance: white to almost white, fine-crystalline powder
Appearance of solution (100 g/l, hydrochloric acid  2 mol/l): clear and colorless
Spec. rotation (α 20/D, 20 g/l, hydrochloric acid 1 mol/l, previously dried substance): -215 to -225
Heavy metals (as Pb): ≤ 10 ppm
Pb (Lead): ≤ 5 ppm
Ninhydrin - positive substances (LC) (largest single impurity): ≤ 0.2 %
Ninhydrin - positive substances (LC) (Sum of all impurities): ≤ 0.5 %
Sulfated ash (800 °C): ≤ 0.1 %
Loss on drying (105 °C; 3 h): ≤ 0.2 %
Corresponds to FCC V

Note legali

SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

Informazioni sulla sicurezza

• Codice della classe di stoccaggio: 11 - Combustible Solids
• Classe di pericolosità dell'acqua (WGK): WGK 1
• Punto d’infiammabilità (°F): Not applicable
• Punto d’infiammabilità (°C): Not applicable