ANALYSIS | SPECIFICATIONS | ||
---|---|---|---|
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≤ 0.04 a.u. |
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|
White Powder | ||
|
≥ 99.5% |
||
|
Passes Test | ||
|
≤ 50 EU/g |
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|
Passes Test |
||
Identification (IR) |
Passes Test |
||
|
3.5 – 4.1 |
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|
Clear and Colorless |
||
Total Aerobic Microbial Count |
≤ 100 CFU/g |
||
|
≤ 100 CFU/g |
||
Water (by Karl Fischer) |
5.0 – 8.9% |
||
|
≤ 5.0 ppm |
Printable Version
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.
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.