Delivering on the Promise of Purity

Delivering on the Promise of PurityTM

Histidine molecular structure used for metal chelation and buffering in biologic formulations

L-Histidine USP, EP, BP, JP, ChP

L-Histidine, High Purity / Low Endotoxin-Low Metals, USP, EP, BP, JP, ChP

Molecular Formula

C6H9N3O2

CAS No

71-00-1

Molecular Weight

155.15

Solubility in Water

38.2 g/L 

Boiling Point

458.9°C

Melting Point

282°C

Quality Level

Highest – Parenteral Excipient Grade cGMP

Suitable for Injectable Biologic & Vaccine Formulations

Drug Master File (DMF) #  CDER 38409

Chinese CDE #  F20200000338

L-Histidine is an essential amino acid that plays a crucial role in various biological processes within the human body. The amino acid has garnered attention in the pharmaceutical industry for its unique ability to enhance the stability of monoclonal antibodies (mAbs) during the manufacturing processes.

Multi-Compendial L-Histidine by Pfanstiehl is used in Protein Stabilization:

Monoclonal antibodies and other protein based biologic therapeutics are inherently susceptible to degradation, aggregation, and loss of activity during manufacturing and storage. L-Histidine emerges as a key player in addressing these challenges due to its unique chemical properties.

 

Buffering Capacity

L-Histidine exhibits an excellent buffering capacity, particularly at pH 7.4, making it an ideal amino acid for maintaining a stable environment during the production and storage of mAbs. The pH level is a critical factor influencing the stability and solubility of proteins. By utilizing the amino acid at pH 7.4, manufacturers create an environment that closely mimics the physiological conditions within the human body, ensuring the stability of mAbs.

 

Metal Ion Chelation

Pfanstiehl Multi-Compendial L-Histidine possesses metal-chelating properties, which can be advantageous in preventing metal-catalyzed oxidation and degradation of mAbs. Metal ions such as copper and iron can accelerate oxidative reactions, leading to the formation of reactive oxygen species. By chelating these ions, the amino acid acts as a protective agent, mitigating the risk of oxidative damage to mAbs.

 

Protein Solubility

The solubility of proteins is a critical parameter during manufacturing and formulation processes. L-Histidine, especially at pH 7.4, aids in maintaining the solubility of monoclonal antibodies, preventing aggregation and precipitation that could compromise the efficacy of the final product.

References/Citations:

Pfanstiehl Histidine Citation Page

Highest cGMP Compendial Quality for your Highest Risk Applications

Pfanstiehl Brand High Purity – Low Endotoxin – Low Metals

 

  • L-Histidine USP EP BP JP ChP
  • L-Histidine Inhalation Grade USP EP BP JP ChP

 

were developed specifically for biopharmaceutical manufacturing and are produced under full ICH-Q7 cGMP conditions in the United States to the highest quality and purity standards.

 

Pfanstiehl Brand Multi-Compendial Amino Acids are compliant with multiple pharmacopoeia.

 

Because of these stringent manufacturing specifications and Pfanstiehl quality systems, you can be assured that Pfanstiehl products will be of the highest quality & consistency from batch to batch and the safest available for use in your manufacturing or research application.

Product Name:

L-Histidine (Plant Derived)

 

L-Histidine Inhalation Grade (Plant Derived)

Quality Level:

Highest – Parenteral Excipient Grade GMP

 

Suitable for Injectable Biologic & Vaccine Formulations

 

Drug Master File (DMF) #  CDER 38409

 

Chinese CDE #  F20200000338

Attributes:

Highest Purity

Lowest Endotoxin

Lowest Metals

Lowest Bioburden

Agency Pharmacopeia:

USP

EP

BP

JP

ChP

Applications:

Parenteral Formulation

Liquid Formulation

Pharmaceutical Process

Biopharma Process

  • Product Name:

    L-Histidine (Plant Derived)

     

    L-Histidine Inhalation Grade (Plant Derived)

  • Quality Level:

    Highest – Parenteral Excipient Grade GMP

     

    Suitable for Injectable Biologic & Vaccine Formulations

     

    Drug Master File (DMF) #  CDER 38409

     

    Chinese CDE #  F20200000338

  • Attributes:

    Highest Purity

    Lowest Endotoxin

    Lowest Metals

    Lowest Bioburden

  • Agency Pharmacopeia:

    USP

    EP

    BP

    JP

    ChP

  • Applications:

    Parenteral Formulation

    Liquid Formulation

    Pharmaceutical Process

    Biopharma Process

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Available Package Sizes:

100g, 1kg, 5kg, 10kg, 25kg, and 50kg

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