Hepes, Free Acid - Excipient

BIO EXCIPIENT GRADE | HE3220 | CAS# 7365-45-9

INTENDED OR USE AS AN EXCIPIENT

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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.


These are general specifications. BioSpectra will customize our products to meet your quality based requirements.

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BIO EXCIPIENT GRADE / HE3220

CAS #: 7365-45-9

Molecular Formula:

C8H18N2O4S

Solubility in Water (g/L): 400

F.W.: 238.30 g/mol

pH @ 20°C: 5.6 - 6.5

Useful pH: 6.8 - 8.2

pKa @ 20˚C: 7.5

 
ANALYSIS SPECIFICATIONS
  250 nm
Absorbance 260 nm
  280 nm
 
0.0500 a.u. maximum
0.0500 a.u. maximum
0.0800 a.u. maximum
Appearance and Color  
White / Crystals
Assay, Dried Basis  
99.5% minimum.
Chloride  
0.005% max..
Enzymes

DNase

RNase
Protease

 

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

Solubility  
Clear
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 Excipient Grade ICH Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes
Each Batch 100% Analyzed  
Yes
Management of Change  
Yes
Validated Analytical Methods  
Yes
Compendial Testing  
Yes
Trace Metals Analyzed  
Yes
Two Year Stability  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Yes
Enzyme Tested  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Suitable for use as Excipient  
Available
Microbial / Endotoxin Tested  
Available
Manufactured in FDA Registered Facility  
Available
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
Accelerated Stability  
Available
Type IV Drug Master File  
Available
Video Conference access to BioSpectra Sites  
Available
Complete access to Product Traceability  
Available
Access to Supply Chain Information  
Yes
ICH Q7 Qualified Utilities  
Yes
ICH Q7 Compliant Manufactured  
Yes
Find your C of As

General Product Description:

  • The manufacturing of HEPES HE3220is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of HE3220 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 HE3220 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 HE3220 is manufactured in
accordance with cGMP guidelines and is suitable to be used only
as the following: ICH Q7 Compliant cGMP Manufactured Excipient
for use in further Manufacturing. This Grade of HEPES is not
suitable to be used as an Active Pharmaceutical Ingredient, Drug
Product or household item.

Expiration/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.