Product Category

GMP Buffer

GMP Manufactured Process Chemical

HEPES, Free Acid, GMP Grade

Product Code: HEPE-4220 | Previously: HE4220

Intended Use Statement


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.
Appearance and Color  
White / Crystals
Assay, Dried Basis  
99.5% min.
Chloride  
0.005% max.
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.
pH (5% Soln)  
5.0 - 6.5
pKa  

7.45 - 7.65

Residue on Ignition 0.1% max.
Solubility (5%)  
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
Key Compliance Attributes of BioSpectra Grades Bio Pharma Grade IPEC GMP Compliant Manufactured
Suitable for Research and Diagnostic  
Yes-image
Each Batch 100% Analyzed  
Yes-image
Management of Change  
Yes-image
Validated Analytical Methods  
Yes-image
Compendial Testing  
Yes-image
Trace Metals Analyzed  
Yes-image
Stability Testing Program  
Yes-image
BioSpectra Supply Chain Audit Trail  
Yes-image
Product Origin Statement  
Yes-image
Customer Quality Audits  
Yes-image
Validated Manufacturing Process  
Yes-image
US Manufactured at BioSpectra  
Yes-image
IPEC cGMP Compliant Manufactured  
Yes-image
Customized Additional Specifications Yes-image
Multi-Compendial Testing  
Yes-image
Low Bioburden Low Endotoxin (LBLE)  
Yes-image
Enzyme Tested  
Yes-image
Suitable for use as Excipient  
Yes-image
Microbial / Endotoxin Tested  
Yes-image
Manufactured in FDA Registered Facility  
Yes-image
Customized Manufacturing Schedule  
Yes-image
Custom Regulatory Packet  
Yes-image
Accelerated Stability  
Yes-image
Video Conference access to BioSpectra Sites  
Yes-image
Complete access to Product Traceability  
Yes-image
Access to Supply Chain Information  
Yes-image

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Pharma Grade: Intended for use as IPEC cGMP Compliant Chemical
LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin).
LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications.

 

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General Product Description:

  • The manufacturing of HEPES HEPE-4220 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of HEPE-4220 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-4220 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 Pharma Grade HEPES, HEPE-4220 is suitable for use as a process chemical. It is manufactured in accordance with the IPEC-PQG Joint Good Manufacturing Practice Guide. This grade of HEPES is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, 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