ANALYSIS | SPECIFICATIONS | ||
---|---|---|---|
|
0.0500 a.u. max 0.0500 a.u. max 0.0500 a.u. max |
||
|
0.0500 a.u. max 0.0500 a.u. max 0.0500 a.u. max |
||
|
White / Crystals | ||
|
99.5% min. | ||
|
0.005% max. | ||
|
≤ 5 EU/g | ||
|
None Detected None Detected None Detected |
||
|
1 ppm max. | ||
|
Passes Test | ||
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≤ 0.01% max. | ||
|
≤ 50 CFU/g ≤ 50 CFU/g |
||
|
4.7 – 5.6 | ||
pKa |
7.45 – 7.65 | ||
|
0.1% max. | ||
|
Pass / Clear Solution | ||
Solubility (0.05M) | Passes Test | ||
|
0.005% max. | ||
|
5 ppm max. 5 ppm max. 5 ppm max. 5 ppm max. |
||
Water Content (Karl Fischer) | 0.5% max. |
Printable Version
ELEMENTAL IMPURITIES: This product complies with ICHQ3D, USP <232> and USP <233> requirements for Elemental Impurities.
RESIDUAL SOLVENTS: Based on the manufacturing process and the controlled handling, storage and analysis of this product, this product complies with the requirements and specifications listed in the current USP method <467> Tables 1, 2, 3, or 4.
Bio Excipient Grade HEPES, HEPE-3251 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of HEPES is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
The recommended retest period for HEPES is two years from the date of manufacture.
Ship and store in ambient temperature. Store in a clean and dry area. Store in the original container.
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.