MES Hydrate GMP Excipient LBLE

Excipient

ICH Q7 GMP Manufactured Product

MES Hydrate

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

*Low Bioburden, Low Endotoxin

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

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

Product Code: MESH-3250

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

MES Hydrate 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 Hydrate to be a Good’s buffer.

CAS #: 1266615-59-1
Formula: C₆H₁₃NO₄S · xH₂O
F.W.: 195.24 g/mol (anhydrous basis)
pH (0.5M): 2.5 - 4.0

Product Specifications

ANALYSIS

SPECIFICATIONS

Absorbance (0.1M)

260 nm
280 nm

< = 0.04 a.u.
< = 0.02 a.u.

Appearance and Color

White Powder

Assay, Anhydrous Basis

> = 99.5%

Cytotoxicity (50%)

Passes Test

Endotoxin

< = 50 EU/g

Enzymes

DNase, Exonuclease

NICKase

RNase

Protease

None Detected

Identification, IR

Conforms to Reference Standard

pH (1.0%)

3.5 – 4.1

Solubility (0.1M)

Clear and Colorless

Microbial Content

TAMC

TYMC

< = 100 CFU/g

Trace Elements

Aluminum (Al)

Antimony (Sb)

Arsenic (As)

Barium (Ba)

Bismuth (Bi)

Cadmium (Cd)

Calcium (Ca)

Chromium (Cr)

Cobalt (Co)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Lithium (Li)

Manganese (Mn)

Magnesium (Mg)

Molybdenum (Mo)

Nickel (Ni)

Sodium (Na)

Zinc (Zn)

< = 5.0 ppm

< = 3.0 ppm

< = 5.0 ppm

< = 20.0 ppm

< = 5.0 ppm

< = 20.0 ppm

< = 5.0 ppm

Water, KF

5.0 - 8.9

Printable Version

Key Product Features:

The manufacturing of MES Hydrate, MESH-3250 is performed at BioSpectra's Bangor, PA facility.
Appears as white 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: 4-Morpholineethanesulfonic Acid Hydrate; 2-(N-Morpholino) ethanesulfonic Acid

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.