Cysteamine HCl Excipient (2-MEA) Excipient GMP Grade

Excipient

ICH-Q7 GMP Manufactured Product

Cysteamine HCl (2-MEA)

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

*Low Bioburden, Low Endotoxin

Minimum Order Quantity: 25kg
Lead Time: 9 months

Product Inquiry COAs Spec Sheet

Click the button above for additional pricing, lead times, MOQs and other inquiries.

Product Inquiry

Product(s) of Interest *

First Name *

Last Name *

Title & Position in Company *

Email *

Your Direct Phone Number & Country Code *

Name of Your Company *

Website of Your Company *

Address of Company *

Country where product is to be used *

Name of Your Customer – the End User *

Website of Your Customer – the End User *

Intended Application/Use if known

Package Size Requested *

Estimated Release Quantity per PO in Liters or Kgs *

Estimated Annual Demand in Liters or Kgs *

Regulatory or Compendial Requirements *

INCO Terms requested *

Please Use the Product Inquiry button (above) for bulk volumes.

Customer Service

First Name *

Last Name *

Company Name *

Position in Company

Email *

Company website

Company phone with country code *

Country where product is to be used *

Street Address *

City *

State *

Zip Code *

Country *

Additional Information Needed/Requested

Please Use the Product Inquiry button (above) for bulk volumes.

UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

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.

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

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

Industry Application:

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

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
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 and Shipping:

Refer to SDS.

Retest Date:

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

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.