Excipient
ICH-Q7 GMP Manufactured ProductHEPES, Free Acid, GMP Excipient Grade
Product Code: HEPE-3220 | Previously: HE3220
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 | |||||||||
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0.0500 a.u. max. 0.0500 a.u. max. 0.0800 a.u. max. |
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| Appearance and Color | White / Crystals | |||||||||
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99.5% min. | |||||||||
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0.005% max. | |||||||||
| Endotoxin | ≤ 5 EU/g | |||||||||
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None Detected None Detected None Detected |
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1 ppm max. | |||||||||
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Passes Test | |||||||||
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0.01% max. | |||||||||
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0.5% max. | |||||||||
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≤ 100CFU/g ≤ 100CFU/g |
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| pH (5% Soln) | 5.0 - 6.5 | |||||||||
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7.45 - 7.65 |
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| Residue on Ignition | 0.1% max. | |||||||||
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Passes Test | |||||||||
| Solubility (0.05M) | Passes Test | |||||||||
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0.005% max. | |||||||||
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5 ppm max. 5 ppm max. 5 ppm max. 5 ppm max. |
| Key Compliance Attributes of BioSpectra Grades | Bio Excipient Grade ICH-Q7 Compliant Manufactured | ||
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| indicates 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. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
- 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 Report - Stroudsburg
- Formaldehyde
- Slip Agent Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Catalyst
- Test Methods
- IRGAFOS
- Stability Report
- Nitrosamine Risk Assessment
- Elemental Impurity Assessment
- Label Copy
- Materials of Conflict Statement
- Certificate of Origin
- Latex Statement
- Antibiotic Statement
- Jatropha Statement
- Degradation and Impurity Report: N02
HEPE-3220
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-3220 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of HEPE-3220 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 HEPE-3220 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.
GMP Compliance:
Bio Excipient Grade HEPES, HEPE-3220 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.
Package Sizes:
10kg, 25kg and 50kg pails.
Additional Packaging Information
https://www.biospectra.us/technical/packaging