Cysteamine HCl Excipient (2-MEA) Excipient GMP Grade

Excipient

ICH Q7 GMP Manufactured Product

Cysteamine HCl (2-MEA)

LBLE*, GMP, Excipient
Product Code: CSMH-3250

*Low Bioburden, Low Endotoxin

Minimum Order Quantity: 25kg
Lead Time: 9 months

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

Product Code: CSMH-3250

Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products.

Cysteamine HCl, also known as 2-MEA, 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 is considered to be an excipient grade product.

CAS #: 156-57-0
Formula: C₂H₇NS • HCl

F.W.: 113.61 g/mol

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance and Color

White or Colorless Crystals or Powder, May Contain Lumps

Appearance of Solution

Colorless, clear solution

Chloride Content

30.6 – 31.8%

Assay, HPLC

98.0 – 102.0%

Microbial Content

TAMC

TYMC

< = 50 CFU/g

Endotoxin

< = 50 EU/g

Cystamine

< = 2.0%

Identification, IR

Conforms to Reference Standard

Loss on Drying

< = 1.0%.

Trace Metals

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

< = 10 ppm

< = 1 ppm

< = 50 ppm

< = 5 ppm

< = 1 ppm

< = 5 ppm

< = 50 ppm

< = 1 ppm

< = 5 ppm

< = 1 ppm

Purity, HPLC (Area %)

> = 98.0%

Purity, HPLC

Cysteamine

Related Substances

> = 92.0%
< = 8.0%

Residual Solvents

Ethanol
Isopropyl Alcohol
Tert-Butylmethyl Ether

< = 5000 ppm
< = 5000 ppm
< = 5000 ppm

Solubility

Clear and Colorless

Printable Version

Key Product Features:

The manufacturing of Cysteamine HCl (2-MEA), CSMH-3250 is performed at BioSpectra’s Bangor, PA facility.
Appears as white or colorless crystals or powder
Manufactured in accordance with ICH Q7
Contains no known major food allergens (as defined by FDA and WHO)
The final product and its raw materials are not derived from nor come into contact with animal parts, animal products, and/or animal byproducts or derivatives
Is not subject to genetic modification
Synonyms: 2 Aminoethanethiol Hydrochloride

Storage & Shipping:

Refer to SDS.

Shelf-Life Policy:

Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Package Sizes:

1kg, 5kg, 10kg, and 25kg 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.