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Excipient

ICH Q7 GMP Manufactured Product

MES Monohydrate

Low PVS, GMP, Excipient
Product Code: MESM-3222

Minimum Order Quantity: 250kg
Lead Time (if no stock): 3-6 months

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Product Code: MESM-3222
Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products.

MES Monohydrate is a zwitterionic buffer that is not absorbed through cell membranes and is virtually transparent in UV light. MES is a buffering agent used in many biological and biochemical applications. It is also used as a running buffer for denaturing gel electrophoresis. The characteristics of low UV absorptivity, minimal reactivity, stable pH and solubility in water allow MES Monohydrate to be a Good’s buffer.

CAS #: 145224-94-8
Formula: C6H13NO4S·H2O
F.W.: 213.25 g/mol
pH (0.5M): 3.5 - 4.5
pKa: 5.9 - 6.3

Product Specifications

ANALYSIS SPECIFICATIONS
Absorbance (1M)

260 nm

280 nm

< = 0.1000 a.u.

< = 0.1000 a.u.

Appearance and Color  
White Crystalline Powder
Assay  
> = 99.5%
Chloride  
< = 50 ppm
Color (1M, Alkaline)  
Colorless
Enzymes

DNase

RNase

Protease

None Detected

None Detected

None Detected

Identification, IR  
Conforms to Reference Standard
Loss on Drying, 130°C 7 - 10%
pH (5%)  
3.1 - 3.5

pH (1.0M)

 
2.7 – 3.7

pH (0.5M)

 
2.5 – 4.5
pKa  

5.9 – 6.3

PVS Limit Test  
< = 1 ppm
Residue on Ignition  
< = 0.05%
Solubility (5%)  
Passes Test
Sulfate  
< = 50 ppm
Trace Metals

Arsenic (As)

Copper (Cu)

Iron (Fe)

Lead (Pb)

< = 2 ppm

< = 2 ppm

< = 2 ppm

< = 2 ppm

Water, KF  
7.9 – 8.9%

 

Printable Version

Key Product Features:

  • The manufacturing of MES Monohydrate, MESM-3222 is performed at BioSpectra’s Bangor, PA facility.
  • Appears as a white crystalline powder
  • Manufactured in accordance with ICH Q7
  • Manufactured in an enzyme free, hormone free, and animal free environment
  • 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-(N-Morpholino) Ethane Sulfonic Acid; 4-Morpholineethanesulfonic Acid Monohydrate

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).

Storage & Shipping:

Refer to SDS. 

Package Sizes:

10kg, 25kg, and 50kg

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.