L-Cystine Dihydrochloride

BIO PHARMA GRADE | CY4250 | CAS# 30925-07-6

C of As and Tech Docs

INTENDED FOR USE IN PHARMACEUTICAL GMP PROCESSES

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BIO PHARMA GRADE / CY4250

CAS #: 30925-07-6

Molecular Formula:

C6H12N2O4S2·2HCl

F.W.: 313.22 g/mol

Useful pH: 0.1

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.


These are general specifications. BioSpectra will customize our products to meet your quality based requirements.

 
  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  
5.0% 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
Each Batch 100% Analyzed  
Yes
Management of Change  
Yes
Validated Analytical Methods  
Yes
Compendial Testing  
Yes
Trace Metals Analyzed  
Yes
Two Year Stability  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Yes
Enzyme Tested  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Suitable for use as Excipient  
Available
Microbial / Endotoxin Tested  
Available
Manufactured in FDA Registered Facility  
Available
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
Accelerated Stability  
Available
List of C of As files
CY4250-021-0520.pdf
CY4250-020-0520.pdf
CY4250-019-0520.pdf
CY4250-018-0520.pdf
CY4250-017-0520.pdf
CY4250-016-0520.pdf
CY4250-015-0520.pdf
CY4250-014-0520.pdf
CY4250-013-0520.pdf
CY4250-012-0520.pdf
CY4250-011-0420.pdf
CY4250-010-0320.pdf
CY4250-009-0120.pdf
CY4250-008-0120.pdf
CY4250-004-1219.pdf
CY4250-003-1219.pdf
CY4250-002-1219.pdf
CY4250-001-0719.pdf

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Review the below Intended End Use Statements for each Grade and Choose the Product Grade that is most applicable to your use.


a.) Bio Pharma Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: IPEC Compliant GMP Manufactured Chemical, for use in further Manufacturing or as a Reagent for Laboratory and Research. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.


b.) Bio Excipient Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient for use in further Manufacturing. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.


c.) O Bio Active Grade INTENDED USE: Material Represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Active Pharmaceutical Ingredient for use in further Manufacturing or use in Drug Product Manufacturing. The material represented by this Grade is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item. (This statement will change depending on the status of your Drug Application in accordance with 21 CFR §201.122)

General Product Description:

  • The manufacturing of L-Cystine dihydrochloride CY4250 is performed at BioSpectra’s Bangor, PA facility utilizing multi-use 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 CY4250 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: IPEC Compliant cGMP Manufactured Chemical for use in further Manufacturing or as a Reagent for Laboratory and Research. This Grade of L-Cystine dihydrochloride is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.

GHS Classification:

  • Pictogram: 
  • Signal word: Danger

Hazardous Statements:
H314 Causes severe skin burns and eye damage
H402 Harmful to aquatic life

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

Expiration/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.

Package Sizes:

10kg and 25kg pails and 50kg drums.