L-Cystine Dihydrochloride GMP

BioBuffer Solution Brand Product

GMP Amino Acid

GMP Manufactured Product

Cystine(L) Dihydrochloride

LBLE*, GMP Grade
Product Code: LCYS-4250

*Low Bioburden, Low Endotoxin

Minimum Order Quantity: 25kg (if no stock)

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

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Product Code: LCYS-4250 | Previously: CY4250

Intended For Use In Pharmaceutical GMP Processes and Products

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.

CAS #: 30925-07-6
Formula: C₆H₁₂N₂O₄S₂·2HCl
MDL Number: MFC00070399
EC#: 250-391-9
F.W.: 313.22 g/mol

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%

Specific Rotation (Free Basis) @ 20°C

-225.0° to -215.0°

Solubility

Passes Test

Printable Version

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 20^oC
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

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.