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  
1.0% 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
Key Compliance Attributes of BioSpectra Grades Bio Pharma Grade IPEC GMP Compliant Manufactured
Suitable for Research and Diagnostic  
Yes-image
Each Batch 100% Analyzed  
Yes-image
Management of Change  
Yes-image
Validated Analytical Methods  
Yes-image
Compendial Testing  
Yes-image
Trace Metals Analyzed  
Yes-image
Stability Testing Program  
Yes-image
BioSpectra Supply Chain Audit Trail  
Yes-image
Product Origin Statement  
Yes-image
Customer Quality Audits  
Yes-image
Validated Manufacturing Process  
Yes-image
US Manufactured at BioSpectra  
Yes-image
IPEC cGMP Compliant Manufactured  
Yes-image
Customized Additional Specifications Yes-image
Multi-Compendial Testing  
Yes-image
Low Bioburden Low Endotoxin (LBLE)  
Yes-image
Enzyme Tested  
Yes-image
Suitable for use as Excipient  
Yes-image
Microbial / Endotoxin Tested  
Yes-image
Manufactured in FDA Registered Facility  
Yes-image
Customized Manufacturing Schedule  
Yes-image
Custom Regulatory Packet  
Yes-image
Accelerated Stability  
Yes-image
Video Conference access to BioSpectra Sites  
Yes-image
Complete access to Product Traceability  
Yes-image
Access to Supply Chain Information  
Yes-image

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Pharma Grade: Intended for use as IPEC cGMP Compliant Chemical
LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin).
LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications.

 

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General Product Description:

  • The manufacturing of L-Cystine dihydrochloride LCYS-4250 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of L-Cystine dihydrochloride is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.
  • 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 


GMP Compliance:

Bio Pharma Grade L-Cystine DiHydrochloride LCYS-4250 is suitable for use as a process chemical. It is manufactured in accordance with the IPEC-PQG Joint Good Manufacturing Practice Guide. This grade of L-Cystine DiHydrochloride is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.

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

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 and 50kg drums.

 

Additional Packaging Information

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