MES, Monohydrate - Excipient

BIO EXCIPIENT GRADE | ME3220 | CAS# 145224-94-8

INTENDED FOR USE IN PHARMACEUTICAL GMP PROCESSES/EXCIPIENT

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BIO EXCIPIENT GRADE / ME3220

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

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.


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

ANALYSIS SPECIFICATIONS
Absorbance 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 (as Pb)  
2 ppm max.
Identification (IR)  
Passes Test
Loss on Drying @ 130°C 7 - 10%
pH (5% solution)  
3.1 - 3.5

pH (0.5M)

 
2.5 – 4.5
pKa  

5.9 – 6.3

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.
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH Q7 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
Type IV Drug Master File  
Available
Video Conference access to BioSpectra Sites  
Available
Complete access to Product Traceability  
Available
Access to Supply Chain Information  
Yes
ICH Q7 Qualified Utilities  
Yes
ICH Q7 Compliant Manufactured  
Yes

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Review the below Intended End Use Statements for each Grade and Choose the Product Grade that is most applicable to your use.


a.) Bio Pharma Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: IPEC Compliant GMP Manufactured Chemical, for use in further Manufacturing or as a Reagent for Laboratory and Research. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.


b.) Bio Excipient Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient for use in further Manufacturing. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.


c.) O Bio Active Grade INTENDED USE: Material Represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Active Pharmaceutical Ingredient for use in further Manufacturing or use in Drug Product Manufacturing. The material represented by this Grade is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item. (This statement will change depending on the status of your Drug Application in accordance with 21 CFR §201.122)

General Product Description:

  • The manufacturing of Bio Excipient Grade MES, Monohydrate ME3220 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, Monohydrate 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 ME3220 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 ME3220 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient for use in further Manufacturing. This Grade of MES, Monohydrate is not suitable to be used as an Active Pharmaceutical Ingredient, 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.