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Product Category

Excipient

ICH-Q7 GMP Manufactured Product

MES, Hydrate, LBLE, GMP Excipient Grade

Product Code: MESH-3250

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Intended For Use As An Excipient


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 Excipient to be used as a Good’s buffer.

Product Specifications

ANALYSIS SPECIFICATIONS

Absorbance 0.1 M in H20

A260
A280

≤ 0.04
≤ 0.02
Appearance  
White Powder

Assay (anhydrous basis)

  

≥ 99.5%

Cytotoxicity

  
Passes Test

Endotoxin

  

< 50 EU/g

Enzymes

DNase, Exonuclease Detection
NICKase, Endonuclease Detection
RNase Detection
Protease Detection

Passes Test
Passes Test
Passes Test
Passes Test

Identification Test (FTIR)

Correlation ≥ 95%

pH 1% in H20

  

3.5 – 4.1

Solubility 0.1M in H20

  

Clear and Colorless

Total Aerobic Microbial Count

≤ 100 CFU/g

Total Yeast and Mold

  

≤ 100 CFU/g

Water (by Karl Fischer)

5.0 – 8.9%

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
≤ 5.0 ppm
≤ 3.0 ppm
≤ 5.0 ppm
≤ 5.0 ppm
≤ 5.0 ppm
≤ 20.0 ppm
≤ 5.0 ppm
≤ 5.0 ppm
≤ 5.0 ppm
≤ 5.0 ppm
≤ 5.0 ppm
≤ 5.0 ppm
≤ 5.0 ppm
≤ 5.0 ppm
≤ 5.0 ppm
≤ 5.0 ppm
≤ 20.0 ppm
≤ 5.0 ppm
Printable Version
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COAs and Tech Docs

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MESH-3250

CAS #: 1266615-59

Formula: C6H13NO4S·H2O

F.W.: 195.25 g/mol

General Product Description:

  • The manufacturing of Bio Excipient Grade MES, Hydrate MESH-3250 is performed at BioSpectra’s Bangor, PA.
  • MES is a White Crystalline product.
  • Molecular Formula: C6H13NO4S·H2O
  • Molecular Weight: 195.25 g/mol.
  • CAS Number: 1266615-59.
  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
  • BioSpectra certifies that all MES, Hydrate MESH-3250 manufactured at BioSpectra and its raw materials are completely synthetic and are not derived from or come in contact with animal parts, products, and/or byproducts.
  • Synonyms: 2-(N-Morpholino)ethanesulfonic acid, 4-Morpholineethanesulfonic acid monohydrate.


GMP Compliance:

Bio Excipient Grade MES, Hydrate MESH-3250 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of MES, Hydrate is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Retest Date:

The recommended retest period for MES, Hydrate is two years from the date of manufacture.

Storage and Shipping Conditions:

Ship and Store in ambient temperature.

Package Sizes:

10kg, 25kg and 50kg pails.

Additional Packaging Information

https://www.biospectra.us/technical/packaging