HEPES Free Acid

Product Specifications

ANALYSIS

SPECIFICATIONS

Absorbance (1M)

250 nm

260 nm

280 nm

0.0500 a.u. max
0.0500 a.u. max
0.0500 a.u. max

Absorbance (0.05M)

250 nm

260 nm

280 nm

0.0500 a.u. max
0.0500 a.u. max
0.0500 a.u. max

Appearance and Color

White / Crystals

Assay, Dried Basis

99.5% min.

Chloride

0.005% max.

Endotoxin

≤ 5 EU/g

Enzymes

DNase

RNase

Protease

None Detected

Heavy Metals (as Lead)

1 ppm max.

Identification (IR)

Passes Test

Insoluble Matter

≤ 0.01% max.

Microbial Content

TAMC
TYMC

≤ 50 CFU/g
≤ 50 CFU/g

pH (1% Soln.)

4.7 – 5.6

pK_a

7.45 – 7.65

Residue on Ignition

0.1% max.

Solubility (1% soln.)

Pass / Clear Solution

Solubility (0.05M)

Passes Test

Sulfate

0.005% max.

Trace Metals

Arsenic (As)

Copper (Cu)

Iron (Fe)

Lead (Pb)

5 ppm max.

Water Content (Karl Fischer)

0.5% max.

Printable Version

General Product Description:

The manufacturing of HEPES, HEPE-3251 is performed at BioSpectra’s Bangor and Stroudsburg, PA facilities utilizing multi-use equipment. Equipment used in the manufacturing of HEPE-3251 is cleaned in accordance with BioSpectra’s Process Cleaning Validation Master Plan.
HEPES is a White Crystalline Product.
Molecular Formula: C₈H₁₈N₂O₄S
Molecular Weight: 238.30 g/mol.
CAS Number: 7365-45-9.
There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
BioSpectra certifies that all HEPES HEPE-3251 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
HEPES manufactured at BioSpectra and any raw materials used in the manufacture of HEPES at BioSpectra are not subject to genetic modification.
Synonyms: N-(2-Hydroxyethyl)piperazine-N’-2- ethanesulfonic acid, 2-[4-(2-hydroxyethyl)piperazin-1-yl] ethanesulfonic acid.

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.

GMP Compliance:

Bio Excipient Grade HEPES, HEPE-3251 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.

Retest Date:

The recommended retest period for HEPES is two years from the date of manufacture.

Storage and Shipping Conditions:

Ship and store in ambient temperature. Store in a clean and dry area. Store in the original container.

Package Sizes:

10kg, 25kg and 50kg pails.

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.