ICH-Q7 GMP Manufactured Product
*Low Bioburden, Low Endotoxin
HEPES is a zwitterionic buffer used to maintain pH of media used in cell cultures. It is one of Good’s twelve buffers that has a pKa value similar to its pH value making it an ideal buffer for pH maintenance. It has only one restriction, it interferes with the Folin protein assay. This buffer can form radicals so it is not suitable for redox studies. HEPES is used as 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
Sol. In H2O (g/L): 400
F.W.: 238.30 g/mol
pH @ 20°C: 5.0 - 6.5
Useful pH: 6.8 - 8.2
pKa @ 20˚C: 7.55
| 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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Conforms | ||
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99.5% min. | ||
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≤ 50 ppm | ||
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≤ 5 EU/g | ||
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None Detected None Detected |
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≤ 1 ppm | ||
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Passes Test | ||
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Conforms | ||
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≤ 0.01% | ||
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≤ 0.2% | ||
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≤ 3000 ppm | ||
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Conforms
Conforms
Conforms
Conforms
Conforms
≤ 100 CFU/g ≤ 50 CFU/g |
||
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5.0 – 6.5 | ||
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4.7 – 5.3 | ||
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7.45 – 7.65 |
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≤ 0.1% | ||
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Passes Test | ||
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≤ 50 ppm | ||
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≤ 0.10% | ||
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≤ 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
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-3250 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.