HEPES

Excipient

ICH Q7 GMP Manufactured Product

HEPES

Low UV, LBLE*, GMP, Excipient
Product Code: HEPE-3251

*Low Bioburden, Low Endotoxin

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

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

Product Code: HEPE-3251

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 @ 25°C: 5.0 - 6.5
pK_a: 7.45 - 7.65

Product Specifications

ANALYSIS

SPECIFICATIONS

Absorbance (1M)

250 nm

260 nm

280 nm

< = 0.0500 a.u.

Absorbance (0.05M)

250 nm

260 nm

280 nm

< = 0.0500 a.u.

Appearance and Color

White Crystals

Assay, Dried Basis

> = 99.5%

Chloride

< = 50 ppm

Endotoxin

< = 5 EU/g

Enzymes

DNase

RNase

Protease

None Detected

Identification, IR

Conforms to Reference Standard

Insoluble Matter

< = 0.01%

Microbial Content

TAMC

TYMC

< = 50 CFU/g

pH (1%)

4.7 – 5.6

pK_a

7.45 – 7.65

Residue on Ignition

< = 0.1%

Solubility

Solubility (1%)

Solubility (0.05M)

Passes Test

Sulfate

< = 50 ppm

Trace Metals

Arsenic (As)

Copper (Cu)

Iron (Fe)

Lead (Pb)

< = 5 ppm

< = 1 ppm

Water, KF

< = 0.5%

Printable Version

Key Product Features:

The manufacturing of HEPES, HEPE-3251 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.
Synonyms: N-(2-Hydroxyethyl) Piperazine-N’-2-Ethanesulfonic Acid; 2-[4-(2-Hydroxyethyl) Piperazin-1-yl] 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.