Product Category


ICH-Q7 GMP Manufactured Product

MES, Monohydrate, LBLE
GMP Excipient Grade

Low Bioburden, Low Endotoxin, GMP Manufactured

Product Code: MESM-3250

Intended For Use As An 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

Absorbance (1M) 260 nm 
280 nm 
0.1000 a.u. max.
0.1000 a.u. max.
Appearance and Color  
White / Crystals
≥ 99.5% min.
0.005% max.
Color (1M, Alkaline)  
Endotoxin < 50 EU/g


None Detected
None Detected
None Detected
Heavy Metals (as Pb)  
2 ppm max.
Identification (IR)  
Passes Test
Loss on Drying @ 130°C 7 - 9%
pH (5% solution)  
3.1 – 3.5

pH (0.5M)

2.5 – 4.0

5.9 – 6.3

Residue on Ignition  
0.05% max.
Solubility (5%)  
Passes Test
0.005% max.
TAMC ≤ 100 CFU/g
TYMC ≤ 100 CFU/g
Trace Elements Cadmium (Cd)
Lead (Pb)
Arsenic (As)
Mercury (Hg)
Cobalt (Co)
Vanadium (V)
Nickel (Ni)
Lithium (Li)
Antimony (Sb)
Barium (Ba)
Molybdenum (Mo)
Copper (Cu)
Tin (Sn)
Chromium (Cr)
Iron (Fe)
≤ 0.2 ppm
≤ 0.5 ppm
≤ 1.5 ppm
≤ 0.3 ppm
≤ 0.5 ppm
≤ 1 ppm
≤ 2 ppm
≤ 25 ppm
≤ 9 ppm
≤ 70 ppm
≤ 150 ppm
≤ 30 ppm
≤ 60 ppm
≤ 110 ppm
≤ 2 ppm
Water (by Karl Fischer) 7.8 – 8.9%
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH-Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Each Batch 100% Analyzed  
Management of Change  
Validated Analytical Methods  
Compendial Testing  
Trace Metals Analyzed  
Stability Testing Program  
BioSpectra Supply Chain Audit Trail  
Product Origin Statement  
Customer Quality Audits  
Validated Manufacturing Process  
US Manufactured at BioSpectra  
Customized Additional Specifications  
Multi-Compendial Testing  
Low Bioburden Low Endotoxin (LBLE)  
Enzyme Tested  
Suitable for use as Excipient  
Microbial / Endotoxin Tested  
Manufactured in FDA Registered Facility  
Customized Manufacturing Schedule  
Custom Regulatory Packet  
Accelerated Stability  
Video Conference access to BioSpectra Sites  
Complete access to Product Traceability  
Access to Supply Chain Information  
ICH-Q7 Qualified Utilities  
ICH-Q7 Compliant Manufactured  
Type II Drug Master File  

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient 
LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin).
LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications.


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General Product Description:

  • The manufacturing of Bio Excipient Grade MES, Monohydrate
    MESM-3250 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-3250 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-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, 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