HEPES, Sodium Salt

BIO ULTRA GRADE | HN5250 | CAS#: 75277-39-3

Intended For Use in Commercial Manufacturing, Diagnostic and Laboratory Applications

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BIO ULTRA GRADE | HN5250

CAS #: 75277-39-3

Molecular Formula:

C8H17N2NaO4S

Solubility in Water (g/L): 990

F.W.: 260.29 g/mol

pH @ 20°C: 4.5 - 6.0

Useful pH: 7.8 - 8.2

pKa @ 20˚C: 7.5

COAs and Tech Docs

HEPES Sodium Salt is a zwitterionic salt which is used in the preparation of a HEPES buffer solution. Its pH range of 9.5-11.5 makes an ideal buffer for pH maintenance. HEPES Sodium Salt interferes with the Folin protein assay. The tendency of this buffer to form radicals makes it unsuitable for redox studies.


This is a non-GMP manufactured Product.


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

 

ANALYSIS SPECIFICATIONS
Appearance and Color  
White / Crystals
Infrared Spectrum  
Conforms to Reference
Solubility (Turbidity) 0.1M aqueous Clear
Solubility (Color) 0.1M aqueous  Colorless
Solubility (Form) 0.1M aqueous Solution 
Water (by Karl Fischer)  ≤ 3.0%
Titration with H2SO4  ≥ 96.0%
Cytotoxicity  Pass
Enzymes DNase - Nickase
DNase – Endo / Exonuclease
RNase Detection
Pass
Pass
Pass
pH 1.0% aqueous)  
9.5 – 10.5
Endotoxin  
≤ 4.5 E.U./g
Yeast and Mold ≤ 100 CFU/g
Bioburden ≤ 100 CFU/g
Protease Detection  Pass
UV Absorbance 260nm 0.1M aqueous ≤ 0.04 Abs UN 
UV Absorbance 280nm 0.1M aqueous  ≤ 0.2 Abs UN
Printable Version
Key Compliance Attributes of Bio Ultra Grade
Suitable for Research and Diagnostic Application
C of A Available for Each Lot
Management of Change
Trace Metals Analyzed
Stability Testing Program
BioSpectra Supply Chain Audit Trail
Product Origin Statement
Customer Quality Audits
Customized Additional Specifications
Enzyme Tested
List of C of As files
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Review the below Intended End Use Statements for each Grade and Choose the Product Grade that is most applicable to your use.


a.) Bio Pharma Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: IPEC Compliant GMP Manufactured Chemical, for use in further Manufacturing or as a Reagent for Laboratory and Research. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.


b.) Bio Excipient Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient for use in further Manufacturing. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.


c.) O Bio Active Grade INTENDED USE: Material Represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Active Pharmaceutical Ingredient for use in further Manufacturing or use in Drug Product Manufacturing. The material represented by this Grade is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item. (This statement will change depending on the status of your Drug Application in accordance with 21 CFR §201.122)

General Product Description:

• HEPES Sodium Salt is a White Crystalline product.
• Molecular Formula: C8H17N2NaO4S  
• Molecular Weight: 260.29 g/mol.
• CAS Number: 75277-39-3.
• Synonyms: 4-(2-Hydroxyethyl)piperazine-1-ethanesulfonic acid sodium salt.

 



Compliance:

Material represented by this grade is suitable to be used only as the following: Quality System Manufactured Process Chemical for use in further manufacturing or as a reagent chemical for commercial manufacturing, diagnostic and laboratory research. The material represented by this grade is not suitable to be used as an Excipient, Active Pharmaceutical Ingredient, Drug, Drug Product or household item.

Expiration/Retest Date:

Two years from date of manufacture, testing and packaging.

Storage and Shipping Conditions:

Ship and Store in ambient temperature.

Package Sizes:

10kg, 25kg and 50kg pails.