Product Category

GMP Process Chemical

GMP Manufactured Product

L-CYSTINE Dihydrochloride
GMP Grade

Product Code: LCYS-4250 | Previously: CY4250

Intended For Use In Pharmaceutical GMP Processes


L-Cystine is a dimer of two Cysteine residues and is a non-essential amino acid. It is synthesized from non-animal derived raw materials under appropriate controls for use in Pharm and Bio-Pharm production under a fully validated GMP manufacturing system. It is also suitable for cell culture media component for the commercial biomanufacturer of therapeutic recombinant proteins and monoclonal antibodies.

Product Specifications

  ANALYSIS SPECIFICATIONS
Appearance and Color  
White to Slightly Yellow Crystalline Powder
Assay (Dried Basis)  
98.0% - 102.0%
Bioburden  
≤ 100 CFU/g
Chloride  
22.2% - 23.5%

Endotoxin 

 
<0.02 EU/mg
Heavy Metals (Pb)

<10 ppm

Identification (IR Spectrum)  

Passes Test

Loss on Drying @ 105°C  
0.5% max.
pH (0.1% soln.)  
Report
Residue on Ignition  
0.1% max.
Specific Rotation (Free Basis) @ 20°C  
-225.0° to -215.0°
Solubility Passes Test 
Printable Version
List of C of As files
LCYS-0124-00013_LCYS-4250.pdf
LCYS-0124-00012_LCYS-4250.pdf
LCYS-0124-00011_LCYS-4250.pdf
LCYS-0124-00010_LCYS-4250.pdf
LCYS-0124-00009_LCYS-4250.pdf
LCYS-0124-00008_LCYS-4250.pdf
LCYS-0124-00005_LCYS-4250.pdf
LCYS-0124-00004_LCYS-4250.pdf
LCYS-0124-00003_LCYS-4250.pdf
LCYS-0124-00002_LCYS-4250.pdf
LCYS-0123-00045_LCYS-4250-25.pdf
LCYS-0123-00044_LCYS-4250-25.pdf
LCYS-0123-00043_LCYS-4250-25.pdf
LCYS-0123-00050_LCYS-4250.pdf
LCYS-0123-00049_LCYS-4250.pdf
LCYS-0123-00048_LCYS-4250.pdf
LCYS-0123-00047_LCYS-4250.pdf
LCYS-0123-00046_LCYS-4250.pdf
LCYS-0123-00042_LCYS-4250.pdf
LCYS-0123-00041_LCYS-4250.pdf
LCYS-0123-00040_LCYS-4250.pdf
LCYS-0123-00039_LCYS-4250.pdf
LCYS-0123-00038_LCYS-4250.pdf
LCYS-0123-00037_LCYS-4250.pdf
LCYS-0123-00026_LCYS-4250.pdf
LCYS-0123-00025_LCYS-4250.pdf
LCYS-0123-00024_LCYS-4250.pdf
LCYS-0123-00023_LCYS-4250.pdf
LCYS-0123-00036_LCYS-4250.pdf
LCYS-0123-00035_LCYS-4250.pdf
LCYS-0123-00034_LCYS-4250.pdf
LCYS-0123-00033_LCYS-4250.pdf
LCYS-0123-00032_LCYS-4250.pdf
LCYS-0123-00031_LCYS-4250.pdf
LCYS-0123-00030_LCYS-4250.pdf
LCYS-0123-00029_LCYS-4250.pdf
LCYS-0123-00028_LCYS-4250.pdf
LCYS-0123-00027_LCYS-4250.pdf
LCYS-0123-00022_LCYS-4250.pdf
LCYS-0123-00021_LCYS-4250.pdf
LCYS-0123-00017_LCYS-4250.pdf
LCYS-0123-00014_LCYS-4250.pdf
LCYS-0123-00011_LCYS-4250.pdf
LCYS-0123-00008_LCYS-4250.pdf
LCYS-0123-00018_LCYS-4250.pdf
LCYS-0123-00016_LCYS-4250.pdf
LCYS-0123-00015_LCYS-4250.pdf
LCYS-0123-00013_LCYS-4250.pdf
LCYS-0123-00012_LCYS-4250.pdf
LCYS-0123-00010_LCYS-4250.pdf
LCYS-0123-00020_LCYS-4250.pdf
LCYS-0123-00009_LCYS-4250.pdf
LCYS-0123-00007_LCYS-4250.pdf
LCYS-0123-00006_LCYS-4250.pdf
LCYS-0123-00005_LCYS-4250.pdf
LCYS-0123-00004_LCYS-4250-10.pdf
LCYS-0123-00003_LCYS-4250.pdf
LCYS-0123-00002_LCYS-4250.pdf
LCYS-0123-00001_LCYS-4250-25.pdf
LCYS-0122-00013_LCYS-4250.pdf
LCYS-0122-00012_LCYS-4250.pdf
LCYS-0122-00011_LCYS-4250.pdf
LCYS-0122-00010_LCYS-4250.pdf
LCYS-0122-00004_LCYS-4250.pdf
LCYS-0122-00003_LCYS-4250.pdf
LCYS-0122-00002_LCYS-4250.pdf
LCYS-0122-00001_LCYS-4250.pdf
LCYS-0121-00024_LCYS-4250.pdf
LCYS-0122-00007_LCYS-4250.pdf
LCYS-0122-00006_LCYS-4250.pdf
LCYS-0122-00005_LCYS-4250.pdf
LCYS-0121-00023_LCYS-4250.pdf
LCYS-0121-00020_LCYS-4250.pdf
LCYS-0121-00031_LCYS-4250.pdf
LCYS-0121-00030_LCYS-4250.pdf
LCYS-0121-00029_LCYS-4250.pdf
LCYS-0121-00028_LCYS-4250.pdf
LCYS-0121-00027_LCYS-4250.pdf
LCYS-0121-00026_LCYS-4250.pdf
LCYS-0121-00025_LCYS-4250.pdf
LCYS-0121-00022_LCYS-4250.pdf
LCYS-0121-00016_LCYS-4250.pdf
LCYS-0121-00013_LCYS-4250.pdf
LCYS-0121-00014_LCYS-4250.pdf
LCYS-0121-00015_LCYS-4250.pdf
LCYS-0121-00012_LCYS-4250.pdf
LCYS-0121-00011_LCYS-4250.pdf
LCYS-0121-00010_LCYS-4250.pdf
LCYS-0121-00005_LCYS-4250.pdf
LCYS-0121 -0174_LCYS-4250.pdf
LCYS-0121-00004_LCYS-4250.pdf
LCYS-0121-00003_LCYS-4250.pdf
LCYS-0121-0138_LCYS-4250.pdf
LCYS-0121-0161_LCYS-4250.pdf
LCYS-0121-0084.pdf
LCYS-0121-0092.pdf
LCYS-0121-0094.pdf
CY4250-032-0221 K038.35.pdf
CY4250-033-0221 K050.pdf
CY4250-033-0221 K023.85.pdf
CY4250-031-0221.pdf
CY4250-029-0221.pdf
CY4250-028-0221.pdf
CY4250-025-0121.pdf
CY4250-026-0221.pdf
CY4250-018-0520 (2).pdf
CY4250-021-0520 (2).pdf
CY4250-008-0120 (3).pdf
CY4250-023-1020.pdf
CY4250-021-0520.pdf
CY4250-020-0520.pdf
CY4250-019-0520.pdf
CY4250-008-0120.pdf
CY4250-018-0520.pdf
CY4250-017-0520.pdf
CY4250-016-0520.pdf
CY4250-015-0520.pdf
CY4250-014-0520.pdf
CY4250-013-0520.pdf
CY4250-012-0520.pdf
CY4250-011-0420.pdf
CY4250-010-0320.pdf
CY4250-009-0120.pdf
CY4250-003-1219.pdf
CY4250-002-1219.pdf
CY4250-004-1219.pdf
CY4250-001-0719.pdf

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General Product Description:

  • L-Cystine dihydrochloride is a White to Pale Yellow Crystalline Powder.
  • Molecular Formula: C6H12N2O4S2·2HCl
  • Molecular Weight: 313.22 g/mol.
  • CAS Number: 30925-07-6 

 

Physical and Chemical Properties:

Form: Solid
Color: White to Pale Yellow
Melting Point: 228-232 oC
Relative Density:1.5178 g/cm3at 20oC
Soluble in Water



GMP Compliance:

Bio Pharma Grade L-Cystine DiHydrochloride LCYS-4250 is suitable for use as a process chemical. It is GMP manufactured by the approved supplier in accordance with the approved supplier’s ISO 9001:2015 certified management system. This grade of L-Cystine DiHydrochloride is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.

Retest Date:

The recommended retest period for L-Cystine dihydrochloride is two years from the date of manufacture.

Storage and Shipping Conditions:

Keep away from heat. Keep away from sources of ignition. Keep container tightly closed, store in a dry and well ventilated place.

GHS Classification:

 

  • Pictogram: 
  • Signal word: Warning

Hazardous Statements:
H315 - Causes skin irritation
H320 - Causes eye irritation

Package Sizes:

10kg and 25kg pails 

Country of Origin:

India

 

Additional Packaging Information

https://www.biospectra.us/technical/packaging