MES, Monohydrate, GMP, Low PVS (≤ 1ppm)

BIO EXCIPIENT GRADE / ME3222

INTENDED FOR USE IN PHARMACEUTICAL GMP PROCESSES/EXCIPIENT

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BIO EXCIPIENT GRADE / ME3222

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 (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
Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes-image
Each Batch 100% Analyzed  
Yes-image
Management of Change  
Yes-image
Validated Analytical Methods  
Yes-image
Compendial Testing  
Yes-image
Trace Metals Analyzed  
Yes-image
Stability Testing Program  
Yes-image
BioSpectra Supply Chain Audit Trail  
Yes-image
Product Origin Statement  
Yes-image
Customer Quality Audits  
Yes-image
Customized Additional Specifications  
Yes-image
Multi-Compendial Testing  
Yes-image
Low Bioburden Low Endotoxin (LBLE)  
Yes-image
Enzyme Tested  
Yes-image
US Manufactured at BioSpectra  
Yes-image
IPEC cGMP Compliant Manufactured  
Yes-image
Suitable for use as Excipient  
Yes-image
Microbial / Endotoxin Tested  
Yes-image
Manufactured in FDA Registered Facility  
Yes-image
Customized Manufacturing Schedule  
Yes-image
Custom Regulatory Packet  
Yes-image
Accelerated Stability  
Yes-image
Type IV Drug Master File  
Yes-image
Video Conference access to BioSpectra Sites  
Yes-image
Complete access to Product Traceability  
Yes-image
Access to Supply Chain Information  
Yes-image
ICH Q7 Qualified Utilities  
Yes-image
ICH Q7 Compliant Manufactured  
Yes-image
Type IV Drug Master File  
Yes-image

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 Excipient
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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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 ME3222 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.
  • HEPES is a White Crystalline Product.
  • 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 ME3222 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 ME3222 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.

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.