Product Category

Excipient

ICH-Q7 GMP Manufactured Product

MES, Monohydrate, Low PVS
GMP Excipient Grade

Product Code: MESM-3222 | Previously: ME3222

Intended For Use In Pharmaceutical GMP Processes/Excipient


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 Excipient to be used as a Good’s buffer.

Product Specifications

ANALYSIS SPECIFICATIONS
Absorbance (1M) 260 nm
280 nm
0.1000 a.u. max.
0.1000 a.u. max.
Appearance and Color  
White Crystalline Powder
Assay  
99.5% min.
Chloride  
0.005% max..
Color (1M, Alkaline)  
Colorless
Enzymes

DNase

RNase

Protease

None Detected
None Detected
None Detected
Heavy Metals (as Pb)  
2 ppm max.
Identification (IR)  
Conforms to Reference
Loss on Drying @ 130°C 7 - 10%
pH (5% solution)  
3.1 - 3.5

pH (1.0M)

 
2.7 – 3.7

pH (0.5M)

 
2.5 – 4.5
pKa  

5.9 – 6.3

Turbidimetry/PVS Limit Test  
≤ 1 ppm
Residue on Ignition  
0.05% max.
Solubility  
Passes Test
Sulfate  
0.005% max.
Trace Elements Arsenic (As)
Copper (Cu)
Iron (Fe)
Lead (Pb)
2 ppm max.
2 ppm max.
2 ppm max.
2 ppm max.
Water (by Karl Fischer)  
7.9 – 8.9%
Printable Version

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General Product Description:

  • The manufacturing of Bio Excipient Grade MES, Monohydrate MESM-3222 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of Bio Excipient Grade MES, Monohydrate is cleaned in accordance with
  • BioSpectra’s Cleaning Validation Plan.
  • MES is a White Crystalline product.
  • Molecular Formula: C6H13NO4S·H2O
  • Molecular Weight: 213.25 g/mol.
  • CAS Number: 145224-94-8.
  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
  • BioSpectra certifies that all MES, Monohydrate MESM-3222 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
  • MES, Monohydrate manufactured at BioSpectra and any raw materials used in the manufacture of MES, Monohydrate at BioSpectra are not subject to genetic modification.
  • Synonyms: 2-(N-Morpholino)ethanesulfonic acid, 4-Morpholineethanesulfonic acid monohydrate.


GMP Compliance:

Bio Excipient Grade MES, Monohydrate MESM-3222 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of MES, Monohydrate is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Retest Date:

The recommended retest period for MES, Monohydrate 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