MES Monohydrate, Enzyme Free, BET, GMP, Excipient

Excipient

ICH Q7 GMP Manufactured Product

MES Monohydrate

Product Code: MESM-3251

*Bioburden and Endotoxin Tested

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Product Code: MESM-3251

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
pK_a: 5.9 - 6.3

Product Specifications

Analysis

Specifications

Absorbance (0.1M)

260nm

< = 0.04 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

Identification, IR

Conforms to Reference Standard

Loss on Drying, 130°C

7 - 9%

Microbial Content

TAMC

TYMC

< = 100 CFU/g

pH (1%)

3.0 - 5.0

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-3251 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.