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

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

Benefits of L-Histidine in mAb 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 L-Histidine 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

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, L-Histidine 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 L-Histidine’s are compliant with multiple pharmacopoeia.

 

Because of these stringent manufacturing specifications and Pfanstiehl quality systems, you can be assured that Pfanstiehl’s L-Histidine 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 – Compendial Parenteral Excipient Grade GMP

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 – Compendial Parenteral Excipient Grade GMP

  • 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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