Excipient
ICH-Q7 GMP Manufactured ProductHEPES, Free Acid, LBLE
GMP Excipient Grade
Low Bioburden, Low Endotoxin, GMP Manufactured
Product Code: HEPE-3250 | Previously: HE3250
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. ≤0.0500 a.u. ≤0.0800 a.u. |
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White / Crystals | ||
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Conforms | ||
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99.5% min. | ||
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≤ 50 ppm | ||
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≤ 5 EU/g | ||
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None Detected None Detected |
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≤ 1 ppm | ||
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Passes Test | ||
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Conforms | ||
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≤ 0.01% | ||
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≤ 0.2% | ||
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≤ 3000 ppm | ||
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Conforms
Conforms
Conforms
Conforms
Conforms
≤ 100 CFU/g ≤ 50 CFU/g |
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5.0 – 6.5 | ||
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4.7 – 5.3 | ||
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7.45 – 7.65 |
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≤ 0.1% | ||
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Passes Test | ||
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≤ 50 ppm | ||
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≤ 0.10% | ||
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≤ 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 |
| 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. |
| List of C of As files |
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HE3250-003-0820.pdf |
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HE3250-004-0820.pdf |
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HE3250-005-0820.pdf |
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
- Nitrosamine Risk Assessment
- Elemental Impurity Assessment
- Label Copy
- Materials of Conflict Statement
- Certificate of Origin
- Latex Statement
- Degradation and Impurity Report: N02
- External Validation Report Filter Change
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