ICH-Q7 GMP Manufactured Product
MES Monohydrate
*Low Bioburden, Low Endotoxin
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.
CAS #: 145224-94-8
Formula: C6H13NO4S·H2O
Sol. In H2O (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
Product Specifications
| ANALYSIS | SPECIFICATIONS | |||
|---|---|---|---|---|
|
0.1000 a.u. max. 0.1000 a.u. max. |
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|
White / Crystals | |||
|
≥ 99.5% min. | |||
|
0.005% max. | |||
|
Colorless | |||
| Endotoxin | < 50 EU/g | |||
|
None Detected None Detected None Detected |
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|
2 ppm max. | |||
|
Passes Test | |||
| Loss on Drying @ 130°C | 7 - 9% | |||
|
3.1 – 3.5 | |||
|
2.5 – 4.0 | |||
|
5.9 – 6.3 |
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|
0.05% max. | |||
|
Passes Test | |||
|
0.005% max. | |||
| TAMC | ≤ 100 CFU/g | |||
| TYMC | ≤ 100 CFU/g | |||
|
≤ 9 ppm ≤ 1.5 ppm ≤ 70 ppm ≤ 0.2 ppm ≤ 110 ppm ≤ 0.5 ppm ≤ 30 ppm ≤ 2 ppm ≤ 0.5 ppm ≤ 25 ppm ≤ 0.3 ppm ≤ 150 ppm ≤ 2 ppm ≤ 60 ppm ≤ 1 ppm |
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| Water (by Karl Fischer) | 7.8 – 8.9% |
Printable Version
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.
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.