Product Category


ICH-Q7 GMP Manufactured Product

Cysteamine 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

Appearance and Color  
White or colorless crystals or powder, may contain lumps
Appearance of Solution  
Colorless, clear solution
Argentometric Titration  
30.6 – 31.8%
Assay (HPLC Weight %)  
98.0 – 102.0%


≤ 100 CFU/g

≤ 50 EU/g

HPLC Minor Component 1 (Area %)  

Cystamine ≤ 2.0%

Heavy Metals  
≤ 20 mg/kg (ppm)
Identification (IR  
Conforms to reference standard
Loss on Drying  
≤ 1.0%.
Trace Metal Analysis (ICP)

Aluminum (Al)
Arsenic (As)
Barium (Ba)
Bismuth (Bi)
Calcium (Ca)
Cadmium (Cd)
Cobalt (Co)
Chromium (Cr)
Copper (Cu)
Iron (Fe)
Mercury (Hg)
Potassium (K)
Lithium (Li)
Magnesium (Mg)
Manganese (Mn)
Molybdenum (Mo)
Sodium (Na)
Nickel (Ni)
Lead (Pb)
Antimony (Sb)
Selenium (Se)
Strontium (Sr)
Vanadium (V)
Zinc (Zn)

≤ 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
Residual Solvents

Isopropyl Alcohol (IPA)
Tert-Butylmethyl Ether

 ≤ 5000 ppm
≤ 5000 ppm
≤ 5000 ppm
Solubility Clear and Colorless
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH-Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Each Batch 100% Analyzed  
Management of Change  
Validated Analytical Methods  
Compendial Testing  
Trace Metals Analyzed  
Stability Testing Program  
BioSpectra Supply Chain Audit Trail  
Product Origin Statement  
Customer Quality Audits  
Validated Manufacturing Process  
US Manufactured at BioSpectra  
Customized Additional Specifications  
Multi-Compendial Testing  
Low Bioburden Low Endotoxin (LBLE)  
Enzyme Tested  
Suitable for use as Excipient  
Microbial / Endotoxin Tested  
Manufactured in FDA Registered Facility  
Customized Manufacturing Schedule  
Custom Regulatory Packet  
Accelerated Stability  
Video Conference access to BioSpectra Sites  
Complete access to Product Traceability  
Access to Supply Chain Information  
ICH-Q7 Qualified Utilities  
ICH-Q7 Compliant Manufactured  
Type II Drug Master File  

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient 
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.


Product Inquiry

Please enter your first name

Please enter title

Please enter product of interest

Enter name of company

Please enter your last name

Please enter your valid email address

Enter position in company

Location of company
Please enter street address

Enter your company state

Invalid Input

Please enter city

Enter zip code

Enter Country

Enter country code

Enter phone number

Enter web address

Please select any option

If resale please fill out the following information
Enter end use customer's full name

Enter end use customer's address

Please select any option

Please select any one option

Please select any option

Invalid Input

Please select any one option

Invalid Input

Invalid Input

Please enter Estimated Release quantity in Liters or Kg

Please enter Regulatory Requirements

Please enter timeframe needed

Please enter Estimated annual demand in liters or kg

Please enter Logistics: Freight

Please enter specificatoin

Validate Recaptcha

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