MES, Monohydrate - GMP Buffer

BIO PHARMA GRADE | ME4220 | CAS# 145224-94-8

INTENDED FOR USE IN PHARMACEUTICAL GMP PROCESSES

Product-image

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 to be used as a Good’s buffer.


These are general specifications. BioSpectra will customize our products to meet your quality based requirements.

formula-image

BIO PHARMA GRADE / ME4220

CAS #: 145224-94-8

Molecular Formula:

C6H13NO4S·H2O

Solubility in Water (g/L): 310

F.W.: 213.25 g/mol

pH @ 20°C: 2.5 - 4.5

Useful pH: 5.5 - 6.7

pKa @ 20˚C: 6.1

 
ANALYSIS SPECIFICATIONS
   
Absorbance (1M) 260 nm
  280 nm
 
 
0.1000 a.u. max.
0.1000 a.u. max.
Appearance and Color  
White / Crystals
Assay  
99.0% min.
Chloride  
0.005% max..
Color (1M, Alkaline)  
Colorless
Enzymes

DNase

RNase
Protease

 

None Detected
None Detected
None Detected
   
Heavy Metals)  
2 ppm max.
Identification (IR)  
Passes Test
pH (5% Soln.)  
3.0 – 3.5

pH (0.5M)

 
2.5 – 4.5
pKa  

5.9 – 6.3

Residue on Ignition  
0.05% max.
Solubility (5%)  
Passes Test
Sulfate  
0.005% max.
Trace Metals Arsenic (As)  
Copper (Cu)
Iron (Fe)
Lead (Pb)
5 ppm max.
5 ppm max.
5 ppm max.
5 ppm max.
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Pharma Grade IPEC GMP Compliant Manufactured
Suitable for Research and Diagnostic  
Yes
Each Batch 100% Analyzed  
Yes
Management of Change  
Yes
Validated Analytical Methods  
Yes
Compendial Testing  
Yes
Trace Metals Analyzed  
Yes
Two Year Stability  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Yes
Enzyme Tested  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Suitable for use as Excipient  
Available
Microbial / Endotoxin Tested  
Available
Manufactured in FDA Registered Facility  
Available
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
Accelerated Stability  
Available
Find your C of As

General Product Description:

  • The manufacturing of Bio Pharma Grade MES, Monohydrate ME4220 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of Bio Pharma 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 ME4220 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 Pharma Grade MES, Monohydrate ME4220 is manufactured in
accordance with cGMP guidelines and is suitable to be used only
as the following: IPEC Compliant cGMP Manufactured Chemical,
for use in further Manufacturing or as a Reagent for Laboratory
and Research. This Grade of MES, Monohydrate is not suitable
to be used as an Active Pharmaceutical Ingredient, Drug, Drug
Product or household item.

Expiration/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.