GMP Process Chemical
GMP Manufactured ProductL-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 | ||
|---|---|---|---|
|
White to Slightly Yellow Crystalline Powder | ||
|
98.0% - 102.0% | ||
|
≤ 100 CFU/g | ||
|
22.2% - 23.5% | ||
|
<0.02 EU/mg | ||
| Heavy Metals (Pb) |
<10 ppm |
||
|
Passes Test |
||
|
1.0% max. | ||
|
Report | ||
|
0.1% max. | ||
|
-225.0° to -215.0° | ||
| Solubility | Passes Test |
| Key Compliance Attributes of BioSpectra Grades | Bio Pharma Grade IPEC GMP Compliant Manufactured | ||
|---|---|---|---|
|
 |
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
| Customized Additional Specifications | |
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
| indicates 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. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
- Elemental Impurities
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- GMO Statement
- Melamine
- Residual Solvents
- Gluten Free
- Ingredient Declaration
- Prop 65
- Supply Chain
- Imidazole
- TUPP
- Formaldehyde
- Slip Agent Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Catalyst
- Test Methods
- IRGAFOS
- Stability Report
- Nitrosamine Risk Assessment
- Label Copy
LCYS-4250
CAS #: 30925-07-6
Formula:
C6H12N2O4S2·2HCl
MDL Number: MFC00070399
EC#: 250-391-9
F.W.: 313.22 g/mol
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