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Excipient

ICH Q7 GMP Manufactured Product

MES Monohydrate

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

*Low Bioburden, Low Endotoxin

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

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QUANTITY
Product Code: MESM-3250
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 - 5.5
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 Crystals
Assay  
> = 99.5%
Chloride  
< = 50 ppm
Color (1M, Alkaline)  
Colorless
Endotoxin < 50 EU/g
Enzymes

DNase

RNase

Protease

None Detected

None Detected

None Detected

Identification, IR  
Conforms to Reference Standard
Loss on Drying, 130°C 7 - 9%
Microbial Content

TAMC

TYMC

< = 100 CFU/g

< = 100 CFU/g

pH (5%)  
3.1 – 3.5

pH (0.5M)

 
2.5 – 4.0
pKa  

5.9 – 6.3

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

Arsenic (As)

Antimony (Sb)

Barium (Ba)

Cadmium (Cd)

Cobalt (Co)

Copper (Cu)

Chromium (Cr)

Iron (Fe)

Lead (Pb)

Lithium (Li)

Mercury (Hg)

Molybdenum (Mo)

Nickel (Ni)

Tin (Sn)

Vanadium (V)

< = 1.5 ppm

< = 9 ppm

< = 70 ppm

< = 0.2 ppm

< = 0.5 ppm

< = 30 ppm

< = 110 ppm

< = 2 ppm

< = 0.5 ppm

< = 25 ppm

< = 0.3 ppm

< = 150 ppm

< = 2 ppm

< = 60 ppm

< = 1 ppm

Water, KF 7.8 – 8.9%

 

Printable Version

Key Product Features:

  • The manufacturing of MES Monohydrate, MESM-3250 is performed at BioSpectra's Bangor, PA facility.
  • Appears as white crystals
  • Manufactured in accordance with ICH Q7
  • Manufactured in an enzyme free, animal free, and hormone 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.