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.
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.
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.
