ICH-Q7 GMP Manufactured Product
MES
MES Hydrate 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 Hydrate Excipient to be used as a Good’s buffer.
CAS #: 1266615-59-1
Formula: C6H13NO4S·xH2O
Sol. In H2O (g/L): 310
F.W.: 195.24 (anhydrous basis)
pH @ 20°C: 2.5 - 4.5
Useful pH: 5.5 - 6.7
pKa @ 20˚C: 6.1
Product Specifications
| ANALYSIS | SPECIFICATIONS | ||
|---|---|---|---|
|
White | ||
|
Crystalline Powder | ||
|
Colorless | ||
|
Clear | ||
|
Conforms to Structure | ||
|
≤ 9% | ||
|
A290 UV absorbance 20% |
≤ 0.05 a.u. |
||
|
Sum ≤ 5ppm | ||
|
2.5 – 4.0 | ||
| pH 1.0M in H2O |
2.7 – 3.7 | ||
|
≥ 99.5% | ||
|
≤ 1 ppm |
General Product Description:
- The manufacturing of Bio Excipient Grade MES, Hydrate MESH-3201 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of Bio Excipient Grade MES, Hydrate is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.
- MES, Hydrate is a White Crystalline product.
- Molecular Formula: C6H13NO4S·xH2O
- Molecular Weight: 195.24 (anhydrous base).
- CAS Number: 1266615-59-1.
- There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
- BioSpectra certifies that all MES, Hydrate MESH-3201 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
- MES, Hydrate manufactured at BioSpectra and any raw materials used in the manufacture of MES, Hydrate at BioSpectra are not subject to genetic modification.
- Synonyms: 4-Morpholineethanesulfonic acid, 2-(N-Morpholino)ethanesulfonic acid hydrate.
GMP Compliance:
Bio Excipient Grade MES, Hydrate MESH-3201 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of MES, Hydrate is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
Retest Date:
The recommended retest period for MES, Hydrate 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.
Bulk GMP Fine Chemicals exclusively manufactured in North America
American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.