HEPES GMP Excipient

Excipient

ICH Q7 GMP Manufactured Product

HEPES

BET*, GMP, Excipient
Product Code: HEPE-3220

*Bioburden and Endotoxin Tested

Minimum Order Quantity: 250kg
Lead Time (if no stock): 3-6 months

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Product Code: HEPE-3220

Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products.

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 at 25°C: 5.0 - 6.5
pK_a: 7.45 - 7.65

Product Specifications

ANALYSIS

SPECIFICATIONS

Absorbance (0.1M)

250 nm

260 nm

280 nm

< = 0.0500 a.u.

< = 0.0800 a.u.

Absorbance (0.05M)

250 nm

260 nm

280 nm

< = 0.0500 a.u.

< = 0.0800 a.u.

Appearance and Color

White Crystals

Assay, Dried Basis

> = 99.5%

Chloride

< = 50 ppm

Endotoxin

< = 5 EU/g

Enzymes

DNase

Protease

RNase

None Detected

Identification, IR

Conforms to Reference Standard

Insoluble Matter

< = 0.01%

Loss on Drying

< = 0.5%

Microbial Content

TAMC

TYMC

< = 100 CFU/g

pH (5%)

5.0 - 6.5

pK_a

7.45 - 7.65

Residue on Ignition

< = 0.1%

Solubility

Solubility (5%)

Solubility (0.05M)

Passes Test

Sulfate

< = 50 ppm

Trace Metals

Arsenic (As)

Copper (Cu)

Iron (Fe)

Lead (Pb)

< = 5 ppm

< = 1 ppm

Printable Version

Key Product Features:

The manufacturing of HEPES, HEPE-3220 is performed at BioSpectra’s Bangor, PA and Stroudsburg, PA facilities.
Appears as white crystals
Manufactured in accordance with ICH Q7
Manufactured in an enzyme free, hormone free, and animal free environment
Contains no known major food allergens (as defined by FDA and WHO)
The final product and its raw materials are not derived from nor come into contact with animal parts, animal products, and/or animal byproducts or derivatives.
Is not subject to genetic modification
Synonyms: N-(2-Hydroxyethyl) Piperazine-N'-2-Ethanesulfonic Acid; 4-(2-Hydroxyethyl) Piperazine-1-Ethanesulfonic Acid

Shelf-Life Policy:

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).

Storage & Shipping:

Refer to SDS.

Package Sizes:

10kg, 25kg, and 50kg

Bulk GMP Fine Chemicals exclusively manufactured in North America

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.