Biospectra Logo
Product Category

Excipient

ICH-Q7 GMP Manufactured Product

HEPES, Free Acid, LBLE
GMP Excipient Grade

Low Bioburden, Low Endotoxin, GMP Manufactured

Product Code: HEPE-3250 | Previously: HE3250

minimum-quantity-image

Intended For Use As An Excipient


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.

Product Specifications

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
pKa  

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
List of C of As files
HE3250-003-0820.pdf
HE3250-004-0820.pdf
HE3250-005-0820.pdf

Product Inquiry

Please enter your first name

Please enter title

Please enter product of interest

Enter name of company

Please enter your last name

Please enter your valid email address

Enter position in company

Location of company
Please enter street address

Enter your company state

Invalid Input

Please enter city

Enter zip code

Enter Country

Enter country code

Enter phone number

Enter web address

Please select any option

If resale please fill out the following information
Enter end use customer's full name

Enter end use customer's address

Please select any option

Please select any one option

Please select any option

Invalid Input

Please select any one option

Invalid Input

Invalid Input

Please enter Estimated Release quantity in Liters or Kg

Please enter Regulatory Requirements

Please enter timeframe needed

Please enter Estimated annual demand in liters or kg

Please enter Logistics: Freight

Please enter specificatoin

Validate Recaptcha

minimum-quantity-image

COAs and Tech Docs

Product-image
formula-image

HEPE-3250

CAS #: 7365-45-9

Formula: C8H18N2O4S

Sol. In H2O (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

General Product Description:

  • The manufacturing of HEPES, HEPE-3250 is performed at BioSpectra’s Bangor and Stroudsburg, PA facilities utilizing multi-use equipment. Equipment used in the manufacturing of HEPE-3250 is cleaned in accordance with BioSpectra’s Process Cleaning Validation Master 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 HEPE-3250 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, HEPE-3250 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of HEPES is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

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.

Additional Packaging Information

https://www.biospectra.us/technical/packaging