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

Intended Use Statement


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
Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH-Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes-image
Each Batch 100% Analyzed  
Yes-image
Management of Change  
Yes-image
Validated Analytical Methods  
Yes-image
Compendial Testing  
Yes-image
Trace Metals Analyzed  
Yes-image
Stability Testing Program  
Yes-image
BioSpectra Supply Chain Audit Trail  
Yes-image
Product Origin Statement  
Yes-image
Customer Quality Audits  
Yes-image
Validated Manufacturing Process  
Yes-image
US Manufactured at BioSpectra  
Yes-image
Customized Additional Specifications  
Yes-image
Multi-Compendial Testing  
Yes-image
Low Bioburden Low Endotoxin (LBLE)  
Yes-image
Enzyme Tested  
Yes-image
Suitable for use as Excipient  
Yes-image
Microbial / Endotoxin Tested  
Yes-image
Manufactured in FDA Registered Facility  
Yes-image
Customized Manufacturing Schedule  
Yes-image
Custom Regulatory Packet  
Yes-image
Accelerated Stability  
Yes-image
Video Conference access to BioSpectra Sites  
Yes-image
Complete access to Product Traceability  
Yes-image
Access to Supply Chain Information  
Yes-image
ICH-Q7 Qualified Utilities  
Yes-image
ICH-Q7 Compliant Manufactured  
Yes-image
Type II Drug Master File  
Yes-image

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient 
LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin).
LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications.

 

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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