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GMP Biotech Product

CYSTINE (L) DIHYDROCHLORIDE BIOTECH

LBLE*, GMP

*Low Bioburden, Low Endotoxin

COAs Spec Sheet

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Product Code: LCYS-6250
Intended for Use in Biopharmaceutical & Biotechnological Applications and Products

L-Cystine Di HCL is dimer, synthesized and purified under full GMP conditions and is also suitable for cell culture media used in the commercial biomanufacturer of therapeutic recombinant proteins, and monoclonal antibodies.

Formula: C6H12N2O4S2·2HCl
F.W.: 313.22 g/mol
CAS #: 30925-07-6

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

General Product Description:

  • Molecular Formula: C6H12N2O4S2·2HCl
  • Molecular Weight: 313.22 g/mol.
  • CAS Number: 30925-07-6 

L-Cystine Dihydrochloride Biotech:

  • Appears as an off-white to pale-yellow crystalline powder
  • Is manufactured under an ISO Quality Managed cGMP System
  • Manufactured in an enzyme free, hormone free and animal free environment
  • Has no known major food allergens (as defined by FDA and WHO)
  • The final product nor its raw materials are not derived from nor come into contact with animals, animal parts, animal products, and/or animal byproducts or derivatives.
  • Is not subject to genetic modification

Shelf Life Policy:

Three-year expiry from the date of manufacture.

Storage and Shipping Conditions:

Please refer to the SDS for storage and shipping conditions.

Package Size:

100g, 500g, 1kg, 5kg, 10kg, 25kg, 50kg

Bulk GMP Fine Chemicals exclusively manufactured in North America

American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.