Product Category

Excipient

ICH-Q7 GMP Manufactured Product

L-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


L-Cysteamine HCl, a.k.a. 2MEA, has been manufactured for use as a critical process chemical for downstream biological drug manufacturing. L-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
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%

Bioburden

 
≤ 100 CFU/g
Endotoxin

≤ 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

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

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.

 

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Product-image
formula-image

CSMH-3250

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

General Product Description:

  • The manufacturing of L-Cysteamine HCl (2-MEA), CSMH-3250 is performed at BioSpectra’s Bangor, PA facility utilizing multi-use equipment. Equipment used in the manufacturing of L-Cysteamine HCl (2-MEA), CSMH-3250 is cleaned in accordance with BioSpectra’s Process Cleaning Validation Master Plan.
  • L-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 L-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.
  • L-Cysteamine HCl (2-MEA) manufactured at BioSpectra and any raw materials used in the manufacture of L-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 L-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 L-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 L-Cysteamine HCl (2- MEA) is two years 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