HEPES, Free Acid - GMP Buffer
BIO PHARMA GRADE | HE4220 | CAS# 7365-45-9
INTENDED FOR USE IN PHARMACEUTICAL GMP PROCESSES
BIO PHARMA GRADE / HE4220
CAS #: 7365-45-9
Molecular Formula:
C8H18N2O4S
Solubility in Water (g/L): 400
F.W.: 238.30 g/mol
pH @ 20°C: 5.0 – 6.5
Useful pH: 6.8 – 8.2
pKa @ 20˚C: 7.55
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
- Elemental Impurities
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- GMO Statement
- Melamine
- Residual Solvents
- Gluten Free
- Ingredient Declaration
- REACH
- Prop 65
- Stability Data Statement
- Supply Chain
- Imidazole
- TUPP
- Formaldehyde
- Slip Agent Statement
- Nitrosamine Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Catalyst
- Test Methods
- IRGAFOS
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.
| ANALYSIS | SPECIFICATIONS | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|
|
|||||||||
|
White / Crystals | |||||||||
|
99.5% min. | |||||||||
|
0.005% max. | |||||||||
|
None Detected None Detected None Detected |
|||||||||
|
1 ppm max. | |||||||||
|
Passes Test | |||||||||
|
0.01% max. | |||||||||
|
0.5% max. | |||||||||
|
5.0 - 6.5 | |||||||||
|
7.45 - 7.65 |
|||||||||
| Residue on Ignition | 0.1% max. | |||||||||
|
Passes Test | |||||||||
|
0.005% max. | |||||||||
|
5 ppm max. 5 ppm max. 5 ppm max. 5 ppm max. |
| Key Compliance Attributes of BioSpectra Grades | Bio Pharma Grade IPEC GMP Compliant Manufactured | ||
|---|---|---|---|
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Available |
General Product Description:
- The manufacturing of HEPES HE4220 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of HE4220 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 HE4220 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 HE4220 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: IPEC Compliant cGMP Manufactured Chemical for use in further Manufacturing or as a reagent for Laboratory and Research. This Grade of HEPES is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, 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.