L-CYSTINE DIHYDROCHLORIDE BIOTECH, Synthetic

GMP Biotech Product

L-CYSTINE DIHYDROCHLORIDE BIOTECH, Synthetic

LBLE*, GMP (Large Batch - Up to 250kg)
Product Code: LCYS-6350 / BBS

*Low Bioburden, Low Endotoxin

Product Inquiry COAs Spec Sheet

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Price per unit (USD)				Price per kilogram (USD)
100g	500g	1kg	2-5kg (1kg ea)	1x5kg	1x10kg
$225 ea.	$615 ea.	$595 ea.	$575 ea.	$555 /kg	$535 /kg

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

Product Code: LCYS-6350

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

L-Cystine Dihydrochloride is dimer, synthesized and purified under full GMP conditions. It 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.