HEPES, Free Acid, LBLE - HE3250

BIO EXCIPIENT GRADE | HE3250

C of As and Tech Docs

INTENDED FOR USE AS AN EXCIPIENT

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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

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
Absorbance (0.1M)

250 nm

260 nm

280 nm
≤0.0500 a.u.
≤0.0500 a.u.
≤0.0800 a.u.
Appearance and Color  
White / Crystals
Appearance of Solution
(1% Water)		  
Conforms
Assay, Dried Basis  
99.5% min.
Chloride  
≤ 50 ppm
Endotoxins  
≤ 5 EU/g
Enzymes

DNases
(Exo- and endonucleases)

RNase

Protease

None Detected

 

None Detected
None Detected
Heavy Metals (as Pb)  
≤ 1 ppm
Identification (IR)  
Passes Test
Identification (TLC)  
Conforms
Insoluble Matter  
≤ 0.01%

Loss on Drying (105°C)

  
≤ 0.2%

Methanol

  
≤ 3000 ppm
Microbial Content

Bile tolerant Gram negative Bacteria (Absent in 1g)

Candida albicans (Absent in 1g)

Escherichia coli (Absent in 1g)

Pseudomonas aeruginosa (Absent in 1g)

Salmonella species (Absent in 10g)

Staphylococcus aureus (Absent in 1g)

TAMC

TYMC
Conforms
Conforms
Conforms
Conforms
Conforms
Conforms
≤ 100 CFU/g
≤ 50 CFU/g
pH (5% Soln)  
5.0 – 6.5
pH (1% Water)  
4.7 – 5.3
pK a  

7.45 – 7.65
Residue on Ignition  
≤ 0.1%
Solubility (5%)  
Passes Test
Sulfate  
≤ 50 ppm
Sulfated Ash (600°C)  
≤ 0.10%
Trace Metals

Arsenic (As)

Calcium (Ca)

Cadmium (Cd)

Cobalt (Co)

Copper (Cu)

Chromium (Cr)

Iron (Fe)

Lead (Pb)

Magnesium (Mg)

Manganese (Mn)

Nickel (Ni)

Potassium (K)

Zinc (Zn)
≤ 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
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Excipient 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
Stability Testing Program  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Available
Enzyme Tested  
Available
Suitable for use as Excipient  
Yes
Microbial / Endotoxin Tested  
Yes
Manufactured in FDA Registered Facility  
Yes
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Yes
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
Suitable for use as Active Ingredient  
No
Type II Drug Master File  
No
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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:

  • 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.