Excipient
ICH-Q7 GMP Manufactured ProductCysteamine HCl (2-MEA), LBLE
GMP Excipient Grade
Low Bioburden, Low Endotoxin, GMP Manufactured
Product Code: CSMH-3250 | Previously: CH3250
Intended For Use As An Excipient
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.
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 ≤ 1 ppm ≤ 5 ppm ≤ 5 ppm ≤ 10 ppm ≤ 1 ppm ≤ 1 ppm ≤ 1 ppm ≤ 1 ppm ≤ 1 ppm ≤ 1 ppm ≤ 50 ppm ≤ 5 ppm ≤ 5 ppm ≤ 1 ppm ≤ 5 ppm ≤ 50 ppm ≤ 1 ppm ≤ 1 ppm ≤ 1 ppm ≤ 1 ppm ≤ 5 ppm ≤ 1 ppm ≤ 1 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 |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- C of As
- SDS
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- GMO Statement
- Melamine
- Residual Solvents
- Gluten Free
- Prop 65
- Stability Data Statement
- Supply Chain
- Imidazole
- Formaldehyde
- Slip Agent Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Catalyst
- Test Methods
- IRGAFOS
- Nitrosamine Risk Assessment
- Elemental Impurity Assessment
- Label Copy
- Certificate of Origin
- TUPP Bangor
- Stability Report: 2021 for 2MEA
- Stability Report: 2022 for 2MEA
CSMH-3250
CAS #: 156-57-0
Formula: C2H7N1S • HCl
Sol. In H2O (g/L): 113.6
F.W.: 113.61 g/mol
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.
Package Sizes:
10kg, 25kg and 50kg pails.
Additional Packaging Information
https://www.biospectra.us/technical/packaging