HEPES, Free Acid, LBLE - HE3250
BIO EXCIPIENT GRADE | HE3250
INTENDED FOR USE AS AN EXCIPIENT


BIO EXCIPIENT GRADE | HE3250
CAS #: 7365-45-9
Molecular Formula:
C8H18N2O4S
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 | ||
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≤0.0500 a.u. ≤0.0500 a.u. ≤0.0800 a.u. |
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White / Crystals | ||
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Conforms | ||
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99.5% min. | ||
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≤ 50 ppm | ||
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≤ 5 EU/g | ||
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None Detected
None Detected |
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≤ 1 ppm | ||
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Passes Test | ||
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Conforms | ||
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≤ 0.01% | ||
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≤ 0.2% | ||
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≤ 3000 ppm | ||
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Conforms Conforms Conforms Conforms Conforms Conforms ≤ 100 CFU/g ≤ 50 CFU/g |
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5.0 – 6.5 | ||
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4.7 – 5.3 | ||
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7.45 – 7.65 |
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≤ 0.1% | ||
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Passes Test | ||
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≤ 50 ppm | ||
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≤ 0.10% | ||
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≤ 5 ppm ≤ 50 ppm ≤ 5 ppm ≤ 5 ppm ≤ 5 ppm ≤ 5 ppm ≤ 5 ppm ≤ 1 ppm ≤ 10 ppm ≤ 5 ppm ≤ 5 ppm ≤ 50 ppm ≤ 5 ppm |
Key Compliance Attributes of BioSpectra Grades | Bio Excipient ICH Q7 Compliant Manufactured | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Available | ||
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Available | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Available | ||
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Yes | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Yes | ||
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Yes | ||
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Yes | ||
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No | ||
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No |
List of C of As files |
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HE3250-005-0820.pdf |
HE3250-004-0820.pdf |
HE3250-003-0820.pdf |
General Product Description:
- The manufacturing of HEPES HE3250 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of HE3250 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.
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 HE3250 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. Store in a clean and dry area. Store in the original container.
Package Sizes:
10kg, 25kg and 50kg pails.