L-Cystine Dihydrochloride

BioBuffer Solution Brand Product

GMP Biotech Product

L-CYSTINE DIHYDROCHLORIDE BIOTECH, Synthetic

LBLE*, GMP
Product Code: LCYS-6250 / BBS

*Low Bioburden, Low Endotoxin

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Product Code: LCYS-6250

Suitable for use in biological and biotech chemical process applications from R&D through scale cGMP production.

L-Cystine Dihydrochloride is dimer, synthesized under full cGMP conditions and is 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%

Microbial Content

TAMC

TYMC

< 50 CFU/g

Chloride

22.2% - 23.5%

Endotoxin

< 0.02 EU/mg

Heavy Metals (Pb)

< 10 ppm

Identification, IR

Conforms to Reference Standard

Loss on Drying

< = 0.5%

pH (0.1%)

Report

Residue on Ignition

< = 0.1%

Specific Rotation, Free Basis, 20°C

-225.0° to -215.0°

Solubility

Passes Test

Printable Version

Key Product Features:

Appears as a white to slightly yellow crystalline powder
GMP manufactured in accordance with the QMS
Manufactured in an enzyme free, hormone free and animal free environment
Contains 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
Synonyms: (2R)-2-amino-3-[[(2R)-2-amino-2-carboxyethyl] disulfanyl]propanoic acid; diHCl

Shelf-Life Policy:

Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Storage & Shipping:

Refer to SDS.

Package Sizes:

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.