ICH-Q7 GMP Manufactured Product
MES Hydrate
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·H2O
F.W.: 195.25 g/mol
Product Specifications
| ANALYSIS | SPECIFICATIONS | ||
|---|---|---|---|
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≤ 0.04 a.u. |
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White Powder | ||
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≥ 99.5% |
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|
Passes Test | ||
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≤ 50 EU/g |
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|
Passes Test |
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Identification (IR) |
Passes Test |
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3.5 – 4.1 |
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Clear and Colorless |
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Total Aerobic Microbial Count |
≤ 100 CFU/g |
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≤ 100 CFU/g |
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Water (by Karl Fischer) |
5.0 – 8.9% |
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≤ 5.0 ppm |
Printable Version
General Product Description:
- The manufacturing of Bio Excipient Grade MES, Hydrate MESH-3250 is performed at BioSpectra’s Bangor, PA facility.
- MES is a White Crystalline product.
- Molecular Formula: C6H13NO4S·H2O
- Molecular Weight: 195.25 g/mol.
- CAS Number: 1266615-59.
- 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-3250 manufactured at BioSpectra and its raw materials are completely synthetic and are not derived from or come in contact with animal parts, products, and/or byproducts.
- Synonyms: 2-(N-Morpholino)ethanesulfonic acid, 4-Morpholineethanesulfonic acid monohydrate.
GMP Compliance:
Bio Excipient Grade MES, Hydrate MESH-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, 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.