ICH Q7 GMP Manufactured Product
LBLE*, GMP, Excipient
Product Code: HEPE-3250
*Low Bioburden, Low Endotoxin
Minimum Order Quantity: 250kg
Lead Time (if no stock): 3-6 months
HEPES is a zwitterionic buffer used to maintain pH of media used in cell cultures. It is one of Good’s buffers that has a pKa value similar to its pH value, making it an ideal buffer for pH maintenance. A known limitation is its interference with the Folin protein assay. This buffer can form radicals, so it is not suitable for redox studies. HEPES is a Good’s buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water.
CAS #: 7365-45-9
Formula: C8H18N2O4S
F.W.: 238.30 g/mol
pH @ 25°C: 5.0 - 6.5
pKa: 7.45 - 7.65
| ANALYSIS | SPECIFICATIONS | ||
|---|---|---|---|
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< = 0.0500 a.u. < = 0.0500 a.u. < = 0.0800 a.u. |
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|
White Crystals | ||
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Passes Test | ||
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> = 99.5% | ||
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< = 50 ppm | ||
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< = 5 EU/g | ||
|
None Detected None Detected None Detected None Detected |
||
|
Conforms to Reference Standard | ||
|
Conforms to Reference Standard | ||
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< = 0.01% | ||
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< = 0.2% | ||
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< = 100 CFU/g < = 50 CFU/g Absent/g Absent/g Absent/g Absent/g Absent/10g Absent/g |
||
|
5.0 – 6.5 | ||
|
4.7 – 5.3 | ||
|
7.45 – 7.65 |
||
|
< = 0.10% | ||
| < = 3000 ppm | |||
|
Passes Test | ||
|
< = 50 ppm | ||
|
< = 5 ppm < = 50 ppm < = 5 ppm < = 5 ppm < = 5 ppm < = 5 ppm < = 5 ppm < = 1 ppm < = 10 ppm < = 5 ppm < = 5 ppm < = 50 ppm < = 5 ppm |
Printable Version
Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).
Refer to SDS.
10kg, 25kg, and 50kg
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.