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GMP Biotech Product

HEPES BIOTECH

LBLE*, GMP
Product Code: HEPE-4250

*Low Bioburden, Low Endotoxin

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Product Code: HEPE-4250
Suitable for use in biological and biotech chemical process applications from R&D through scale cGMP production.

HEPES, Free Acid 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. HEPES is a Good’s buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water.

Formula: C8H18N2O4S
F.W.: 238.30 g/mol
CAS #: 7365-45-9

Product Specifications

ANALYSIS SPECIFICATIONS
Absorbance (0.1M)

250 nm

260 nm

280 nm

< = 0.0500 a.u.

< = 0.0500 a.u.

< = 0.0800 a.u.

Absorbance (0.5M)

250 nm

260 nm

280 nm

< = 0.0500 a.u.

< = 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

RNase

Protease 

None Detected

None Detected

None Detected

Identification, IR  
Conforms to Reference Standard
Insoluble Matter  
< = 0.01%
Loss on Drying  
< = 0.5%
Microbial Content

TAMC

TYMC

< = 100 CFU/g

< = 100 CFU/g

pH (5%)

 
5.0 - 6.5
pKa  

7.45 - 7.65

Residue on Ignition  
< = 0.1%
Solubility

Solubility (5%)

Solubility (0.05M) 

Passes Test

Passes Test

Sulfate  
< = 50 ppm
Trace Metals

Arsenic (As)

Aluminum (Al)

Bismuth (Bi)

Calcium (Ca)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Lithium (Li)

Molybdenum (Mo)

Nickel (Ni)

Potassium (K)

< = 5 ppm

< = 5 ppm

< = 5 ppm

< = 10 ppm

< = 5 ppm

< = 5 ppm

< = 1 ppm

< = 5 ppm

< = 5 ppm

< = 5 ppm

< = 50 ppm

Water, KF  
< = 0.1%

 

Printable Version

Key Product Features:

  • Appears as a white crystalline product
  • Manufactured in accordance with IPEC
  • 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 animals, 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:

100g, 500g, 1kg, 5kg, 10kg, 25kg, 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.