ICH-Q7 GMP Manufactured Product
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
| 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 |
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.
The recommended retest period for MES, Hydrate is two years from the date of manufacture.
Ship and Store in ambient temperature.
10kg, 25kg and 50kg pails.
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.