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Merck
CN

1.02836

L-Cystine

suitable for biopharmaceutical production FCC

Synonym(s):

L-Cystine, Cys

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About This Item

Empirical Formula (Hill Notation):
C6H12N2O4S2
CAS Number:
56-89-3
Molecular Weight:
240.30
EC Index Number:
200-296-3
UNSPSC Code:
12352209
MDL number:
MFCD00064228

Key Documents

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Product Name

L-Cystine, suitable for biopharmaceutical production FCC

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

InChI key

LEVWYRKDKASIDU-IMJSIDKUSA-N

reg. compliance

FCC

form

solid

mp

261-262 °C (decomposition)

solubility

insoluble 0.19 g/L

density

1.677 g/cm3 at 20 °C

bulk density

300 kg/m3

application(s)

pharma/biopharma processes

storage temp.

2-30°C

Quality Level

300

Analysis Note

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

General description

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.

Legal Information

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

Storage Class

11 - Combustible Solids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificates of Analysis (COA)

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