Product Category

Excipient

ICH-Q7 GMP Manufactured Product

HEPES, Free Acid, GMP Excipient Grade

Product Code: HEPE-3220 | Previously: HE3220

Intended For Use As An Excipient


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.

Product Specifications

ANALYSIS SPECIFICATIONS
  250 nm
Absorbance (0.1M) 260 nm
  280 nm
0.0500 a.u. max.
0.0500 a.u. max.
0.0800 a.u. max.
Absorbance (0.05M)

250 nm

260 nm

280 nm

0.0500 a.u. max.

0.0500 a.u. max.

0.0800 a.u. max.

Appearance and Color White / Crystals
Assay, Dried Basis  
99.5% min.
Chloride  
0.005% max.
Endotoxin ≤ 5 EU/g
Enzymes

DNase

Protease

RNase

None Detected
None Detected
None Detected
Heavy Metals  
1 ppm max.
Identification (IR)  
Passes Test
Insoluble Matter  
0.01% max.

Loss on Drying

 
0.5% max.
Microbial Content

TAMC

TYMC

≤ 100CFU/g

≤ 100CFU/g

pH (5% Soln) 5.0 - 6.5
pKa  

7.45 - 7.65

Residue on Ignition 0.1% max.
Solubility (5%)  
Passes Test
Solubility (0.05M) Passes Test
Sulfate  
0.005% max.
Trace Metals

Arsenic (As)

Copper (Cu)

Iron (Fe)

Lead (Pb)

5 ppm max.
5 ppm max.
5 ppm max.
5 ppm max.
Printable Version
List of C of As files
HEPE-0124-00018_HEPE-3220.pdf
HEPE-0124-00017_HEPE-3220.pdf
HEPE-0124-00010_HEPE-3220.pdf
HEPE-0124-00009_HEPE-3220.pdf
HEPE-0124-00008_HEPE-3220.pdf
HEPE-0124-00007_HEPE-3220.pdf
HEPE-0124-00006_HEPE-3220.pdf
HEPE-0124-00005_HEPE-3220.pdf
HEPE-0124-00004_HEPE-3220.pdf
HEPE-0124-00003_HEPE-3220.pdf
HEPE-0124-00002_HEPE-3220.pdf
HEPE-0124-00001_HEPE-3220.pdf
HEPE-0123-00127_HEPE-3220.pdf
HEPE-0123-00126_HEPE-3220.pdf
HEPE-0123-00125_HEPE-3220.pdf
HEPE-0123-00124_HEPE-3220.pdf
HEPE-0123-00123_HEPE-3220.pdf
HEPE-0123-00122_HEPE-3220.pdf
HEPE-0123-00121_HEPE-3220.pdf
HEPE-0123-00120_HEPE-3220.pdf
HEPE-0123-00119_HEPE-3220.pdf
HEPE-0123-00118_HEPE-3220.pdf
HEPE-0123-00117_HEPE-3220.pdf
HEPE-0123-00116_HEPE-3220.pdf
HEPE-0122-00076_HEPE-3220-10.pdf
HEPE-0123-00115_HEPE-3220.pdf
HEPE-0123-00114_HEPE-3220.pdf
HEPE-0123-00113_HEPE-3220.pdf
HEPE-0123-00112_HEPE-3220.pdf
HEPE-0123-00111_HEPE-3220.pdf
HEPE-0123-00102_HEPE-3220.pdf
HEPE-0123-00093_HEPE-3220.pdf
HEPE-0123-00092_HEPE-3220.pdf
HEPE-0123-00091_HEPE-3220.pdf
HEPE-0123-00063_HEPE-3220-93.pdf
HEPE-0123-00057_HEPE-3220-93.pdf
HEPE-0123-00075_HEPE-3220.pdf
HEPE-0123-00074_HEPE-3220.pdf
HEPE-0123-00062_HEPE-3220.pdf
HEPE-0123-00061_HEPE-3220.pdf
HEPE-0123-00060_HEPE-3220.pdf
HEPE-0123-00059_HEPE-3220.pdf
HEPE-0123-00058_HEPE-3220.pdf
HEPE-0123-00046_HEPE-3220.pdf
HEPE-0123-00040_HEPE-3220-10.pdf
HEPE-0123-00039_HEPE-3220.pdf
HEPE-0123-00038_HEPE-3220.pdf
HEPE-0123-00037_HEPE-3220.pdf
HEPE-0123-00031_HEPE-3220.pdf
HEPE-0123-00024_HEPE-3220.pdf
HEPE-0123-00023_HEPE-3220.pdf
HEPE-0122-00094_HEPE-3220.pdf
HEPE-0122-00093_HEPE-3220.pdf
HEPE-0122-00076_HEPE-3220.pdf
HEPE-0122-00109_HEPE-3220.pdf
HEPE-0122-00109_HEPE-3220-25.pdf
HEPE-0122-00108_HEPE-3220-25.pdf
HEPE-0122-00107_HEPE-3220-25.pdf
HEPE-0122-00101_HEPE-3220.pdf
HEPE-0122-00100_HEPE-3220.pdf
HEPE-0122-00099_HEPE-3220.pdf
HEPE-0122-00098_HEPE-3220.pdf
HEPE-0122-00097_HEPE-3220.pdf
HEPE-0122-00096_HEPE-3220.pdf
HEPE-0122-00095_HEPE-3220.pdf
HEPE-0122-00098_HEPE-3220 (2).pdf
HEPE-0122-00098_HEPE-3220 (1).pdf
HEPE-0122-00067_HEPE-3220.pdf
HEPE-0122-00067_HEPE-3220_500G.pdf
HEPE-0122-00083_HEPE-3220.pdf
HEPE-0122-00082_HEPE-3220.pdf
HEPE-0122-00081_HEPE-3220.pdf
HEPE-0122-00075_HEPES-3220.pdf
HEPE-0122-00068_HEPE-3220.pdf
HEPE-0122-00077_HEPE-3220.pdf
HEPE-0122-00066_HEPE-3220.pdf
HEPE-0122-00065_HEPE-3220.pdf
HEPE-0122-00064_HEPE-3220.pdf
HEPE-0122-00063_HEPE-3220.pdf
HEPE-0122-00062_HEPE-3220.pdf
HEPE-0122-00057_HEPE-3220.pdf
HEPE-0122-00054_HEPE-3220.pdf
HEPE-0122-00053_HEPE-3220.pdf
HEPE-0122-00052_HEPE-3220-93.pdf
HEPE-0122-00052 5_HEPE-3220.pdf
HEPE-0122-00056_HEPE-3220.pdf
HEPE-0122-00050_HEPE-3220.pdf
HEPE-0122-00042_HEPE-3220.pdf
HEPE-0122-00029_HEPE-3220.pdf
HEPE-0122-00028_HEPE-3220.pdf
HEPE-0122-00027_HEPE-3220.pdf
HEPE-0121-00192_HEPE-3220.pdf
HEPE-0122-00041_HEPE-3220.pdf
HEPE-0122-00026_HEPE-3220.pdf
HEPE-0122-00022_HEPE-3220.pdf
HEPE-0122-00021_HEPE-3220.pdf
HEPE-0122-00020_HEPE-3220.pdf
HEPE-0122-00019_HEPE-3220.pdf
HEPE-0122-00018_HEPE-3220.pdf
HEPE-0122-00017_HEPE-3220.pdf
HEPE-0122-00024_HEPE-3220.pdf
HEPE-0122-00015_HEPE-3220.pdf
HEPE-0122-00014_HEPE-3220-25.pdf
HEPE-0122-00023_HEPE-3220.pdf
HEPE-0122-00013_HEPE-3220.pdf
HEPE-0121-00195_HEPE-3220.pdf
HEPE-0221-00123_HEPE-3220-25.pdf
HEPE-0221-00112_HEPE-3220-25.pdf
HEPE-0121-00184_HEPE-3220.pdf
HEPE-0121-00183_HEPE-3220.pdf
HEPE-0121-00182_HEPE-3220.pdf
HEPE-0121-00181_HEPE-3220.pdf
HEPE-0121-00180_HEPE-3220.pdf
HEPE-0121-00179_HEPE-3220.pdf
HEPE-0121-00177_HEPE-3220.pdf
HEPE-0121-00176_HEPE-3220.pdf
HEPE-0121-00175_HEPE-3220.pdf
HEPE-0121-00157_HEPE-3220.pdf
HEPE-0121-00150_HEPE-3220.pdf
HEPE-0121-00149_HEPE-3220.pdf
HEPE-0121-00148_HEPE-3220.pdf
HEPE-0121-00147_HEPE-3220.pdf
HEPE-0121-00146_HEPE-3220.pdf
HEPE-0121-00155_HEPE-3220.pdf
HEPE-0121-00156_HEPE-3220.pdf
HEPE-0121-00142_HEPE-3220.pdf
HEPE-0121-00141_HEPE-3220.pdf
HEPE-0121-00135_HEPE-3220.pdf
HEPE-0121-00134_HEPE-3220.pdf
HEPE-0121-00133_HEPE-3220.pdf
HEPE-0121-00130_HEPE-3220.pdf
HEPE-0121-00129_HEPE-3220.pdf
HEPE-0121-00128_HEPE-3220.pdf
HEPE-0121-00127_HEPE-3220.pdf
HEPE-0121-00101_HEPE-3220.pdf
HEPE-0121-00059_HEPE-3220.pdf
HEPE-0121-00043_HEPE-3220.pdf
HEPE-0121-00042_HEPE-3220.pdf
HEPE-0121-00035_HEPE-3220.pdf
HEPE-0121-00034_HEPE-3220.pdf
HEPE-0121-00032_HEPE-3220.pdf
HEPE-0121-00031_HEPE-3220.pdf
HEPE-0121-00030_HEPE-3220.pdf
HEPE-0121-00029_HEPE-3220.pdf
HEPE-0121-00028_HEPE-3220.pdf
HEPE-0121-00022_HEPE-3220.pdf
HEPE-0121-00027_HEPE-3220.pdf
HEPE-0121-00014_HEPE-3220.pdf
HEPE-0121-00012_HEPE-3220.pdf
HEPE-0121-00013_HEPE-3220.pdf
HEPE-0121-0196_HEPE-3220.pdf
HEPE-0121-0025_HEPE-3220.pdf
HEPE-0121-0089_HEPE-3220.pdf
HEPE-0121-00011_HEPE-3220.pdf
HEPE-0121-0192_HEPE-3220.pdf
HEPE-0121-0194_HEPE-3220.pdf
HEPE-0121-0195_HEPE-3220.pdf
HEPE-0121-0155_HEPE-3220.pdf
HEPE-0121-0156_HEPE-3220.pdf
HEPE-0121-0157_HEPE-3220.pdf
HE3220-061-0121.pdf
HE3220-060-0121.pdf
HE3220-063-0221.pdf
HE3220-062-0221.pdf
HE3220-064-0221.pdf
HEPE-0121-0095.pdf
HE3220-059-0121.pdf
HE3220-058-1220.pdf
HE3220-057-1220.pdf
HE3220-056-1220.pdf
HE3220-055-1220.pdf
HE3220-054-1220.pdf
HE3220-047-1120.pdf
HE3220-044-1120.pdf
HE3220-046-1120.pdf
HE3220-045-1120.pdf
HE3220-048-1120.pdf
HE3220-049-1120.pdf
HE3220-050-1220.pdf
HE3220-051-1220.pdf
HE3220-052-1220.pdf
HE3220-043-1120.pdf
HE3220-042-1120.pdf
HE3220-041-1120.pdf
HE3220-040-1120.pdf
HE3220-039-1120.pdf
HE3220-038-1120.pdf
HE3220-037-1120.pdf
HE3220-036-1120.pdf
HE3220-032-1020.pdf
HE3220-034-1020.pdf
HE3220-033-1020.pdf
HE3220-035-1020.pdf
HE3220-031-0720.pdf
HE3220-030-0720.pdf
HE3220-029-0720.pdf
HE3220-028-0720.pdf
HE3220-027-0720.pdf
HE3220-026-0720.pdf
HE3220-025-0620.pdf
HE3220-024-0620.pdf
HE3220-023-0620.pdf
HE3220-022-0620.pdf
HE3220-021-0620.pdf
HE3220-020-0620.pdf
HE3220-019-0620.pdf
HE3220-018-0620.pdf
HE3220-017-0620.pdf
HE3220-016-0520.pdf
HE3220-014-0520.pdf
HE3220-015-0520.pdf
HE3220-013-0520.pdf

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General Product Description:

  • The manufacturing of HEPES HEPE-3220 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of HEPE-3220 is cleaned in accordance with BioSpectra’s Cleaning Validation 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-3220 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.


GMP Compliance:

Bio Excipient Grade HEPES, HEPE-3220 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.

Package Sizes:

10kg, 25kg and 50kg pails.

Additional Packaging Information

https://www.biospectra.us/technical/packaging