Biospectra Logo
Product Category

Excipient

ICH-Q7 GMP Manufactured Product

MES, Hydrate, LBLE, GMP Excipient Grade

Product Code: MESH-3250

minimum-quantity-image

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 (0.1M) in Water

A260
A280

≤ 0.04 a.u.
≤ 0.02 a.u.
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 (IR)

Passes Test

pH 1% in Water

  

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
List of C of As files
MESH-0123-00003_MESH-3250.pdf
MESH-0123-00002_MESH-3250.pdf
MESH-0123-00001_MESH-3250.pdf

Product Inquiry

Please enter your first name

Please enter title

Please enter product of interest

Enter name of company

Please enter your last name

Please enter your valid email address

Enter position in company

Location of company
Please enter street address

Enter your company state

Invalid Input

Please enter city

Enter zip code

Enter Country

Enter country code

Enter phone number

Enter web address

Please select any option

If resale please fill out the following information
Enter end use customer's full name

Enter end use customer's address

Please select any option

Please select any one option

Please select any option

Invalid Input

Please select any one option

Invalid Input

Invalid Input

Please enter Estimated Release quantity in Liters or Kg

Please enter Regulatory Requirements

Please enter timeframe needed

Please enter Estimated annual demand in liters or kg

Please enter Logistics: Freight

Please enter specificatoin

Validate Recaptcha

minimum-quantity-image
formula-image

COAs and Tech Docs

formula-image

MESH-3250

CAS #: 1266615-59-1

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