ICH-Q7 GMP Manufactured Product
Cysteamine HCl (2-MEA)
*Low Bioburden, Low Endotoxin
Cysteamine HCl, a.k.a. 2MEA, has been manufactured for use as a critical process chemical for downstream biological drug manufacturing. Cysteamine HCl has been manufactured and purified under strict ICH-Q7 guidelines for excipient materials and can be considered an excipient grade product.
CAS #: 156-57-0
Formula: C2H7N1S • HCl
pH @ 25°C: 3.5 - 5.0
Sol. In H2O (g/L): 113.6
F.W.: 113.61 g/mol
Product Specifications:
| ANALYSIS | SPECIFICATIONS | ||
|---|---|---|---|
|
White or colorless crystals or powder, may contain lumps | ||
|
Colorless, clear solution | ||
|
30.6 – 31.8% | ||
|
98.0 – 102.0% | ||
|
≤ 100 CFU/g | ||
| Endotoxin |
≤ 50 EU/g |
||
|
Cystamine ≤ 2.0% |
||
|
≤ 20 mg/kg (ppm) | ||
|
Conforms to reference standard | ||
|
≤ 1.0%. | ||
|
≤ 5 ppm |
||
| Purity (HPLC Area %) | ≥ 98.0% | ||
| Purity (Cysteamine (HPLC)) | ≥ 92.0% ≤ 8.0% related substances |
||
|
≤ 5000 ppm ≤ 5000 ppm ≤ 5000 ppm |
||
| Solubility | Clear and Colorless |
Printable Version
General Product Description:
- The manufacturing of Cysteamine HCl (2-MEA), CSMH-3250 is performed at BioSpectra’s Bangor, PA facility utilizing multi-use equipment. Equipment used in the manufacturing of Cysteamine HCl (2-MEA), CSMH-3250 is cleaned in accordance with BioSpectra’s Process Cleaning Validation Master Plan.
- Cysteamine HCl (2-MEA) is a White Crystalline product
- Molecular Formula: C2H7N1S • HCl
- Molecular Weight: 113.61 g/mol.
- CAS Number: 156-57-0
- There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
- BioSpectra certifies that all Cysteamine HCl (2-MEA), CSMH-3250 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
- Cysteamine HCl (2-MEA) manufactured at BioSpectra and any raw materials used in the manufacture of Cysteamine HCl (2-MEA) at BioSpectra are not subject to genetic modification.
- Synonyms: 2 Aminoethanethiol Hydrochloride
ELEMENTAL IMPURITIES: This product complies with ICHQ3D, USP <232> and USP <233> requirements for Elemental Impurities.
RESIDUAL SOLVENTS: Based on the manufacturing process and the controlled handling, storage and analysis of this product, this product complies with the requirements and specifications listed in the current USP method <467> Tables 1, 2, 3, or 4.
GMP Compliance:
Bio Excipient Grade Cysteamine HCl (2-MEA), CSMH-3250 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Cysteamine HCl (2-MEA) is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
Retest Date:
The recommended retest period for CysteamineHCl (2- MEA) is one year from the date of manufacture.
Product Storage and Shipping Conditions
Store in a tightly closed container, under nitrogen or argon blanket, at 2-8°C (36-46°F). Store in a dry, well- ventilated area away from incompatible substances.
Product Package Sizes
10kg, 25kg and 50kg pails.
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.