L-Cystine Dihydrochloride
BIO PHARMA GRADE | CY4250 | CAS# 30925-07-6
INTENDED FOR USE IN PHARMACEUTICAL GMP PROCESSES
BIO PHARMA GRADE / CY4250
CAS #: 30925-07-6
Molecular Formula:
C6H12N2O4S2·2HCl
F.W.: 313.22 g/mol
Useful pH: 0.1
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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 | ||
|---|---|---|---|
|
White to Slightly Yellow Crystalline Powder | ||
|
98.0% - 102.0% | ||
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≤ 100 CFU/g | ||
|
22.2% - 23.5% | ||
|
<0.02 EU/mg | ||
| Heavy Metals (Pb) |
<10 ppm |
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Passes Test |
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5.0% max. | ||
|
Report | ||
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0.1% max. | ||
|
-225.0° to -215.0° | ||
| Solubility | Passes Test |
|
Key Compliance Attributes of BioSpectra Grades |
Bio Pharma Grade IPEC GMP Compliant Manufactured |
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Available |
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.