Delivering on the Promise of Purity

Delivering on the Promise of PurityTM

L-Arginine molecular structure used to reduce viscosity and prevent aggregation in biologic formulations

L-Arginine USP EP JP ChP

L-Arginine High Purity - Low Endotoxin – Low Metals USP, EP, JP, ChP

Molecular Formula

C6H14N4O2

CAS No

74-79-3

Molecular Weight

174.2

Solubility in Water

15 g/L

Boiling Point

409.1°C

Melting Point

223°C

Quality Level

Highest – Parenteral Excipient Grade cGMP

Suitable for Injectable Biologic & Vaccine Formulations

L-Arginine is an essential amino acid that is physiologically active in the L- form. It plays various roles in the body, including its involvement in protein synthesis. In the context of stabilizing proteins in liquid and lyophilization processes, L-Arginine has been studied for its potential to protect and stabilize proteins during these processes.

 

Lyophilization, also known as freeze-drying, is a process used to remove water from proteins and other biological materials, allowing for their long-term storage and preservation. However, the freeze-drying process can pose challenges to the stability of proteins, as the freezing and drying steps can lead to denaturation or aggregation of the protein molecules.

 

L-Arginine has been investigated for its ability to mitigate these challenges and provide stabilization during lyophilization.

Benefits of using Pfanstiehl L-Arginine in protein stabilization include:

Preventing Aggregation

L-Arginine has been shown to reduce protein aggregation during freezing and drying processes. It helps maintain the native conformation of proteins and prevents them from sticking together, which is crucial for maintaining their biological activity.

 

Maintaining Solubility

L-Arginine can enhance the solubility of proteins in solution, even at low temperatures. This can be advantageous during the freezing step of lyophilization, where maintaining protein solubility is important for preventing aggregation.

 

Protecting Protein Structure

L-Arginine is known for its role in stabilizing protein structures. It can interact with proteins through various mechanisms, including hydrogen bonding and charge interactions, helping to preserve the native structure of proteins.

 

Reducing Ice Crystal Formation

L-Arginine has also been studied for its ability to influence ice crystal formation during freezing. By modifying the freezing process, it may help reduce damage to proteins caused by the formation of ice crystals.

 

Viscosity Reduction

L-Arginine plays a crucial role in mitigating viscosity challenges in high-concentration protein formulations. High protein concentrations often result in increased solution viscosity, which can impede manufacturing processes and affect the administration of therapeutic proteins. L-Arginine’s influence on viscosity reduction is attributed to its role as a solubilizing agent and its ability to disrupt protein-protein interactions. The positively charged guanidinium group of L-Arginine interacts with negatively charged protein surfaces, preventing the formation of aggregates and reducing the overall viscosity of the formulation. This property enhances the flowability of high-concentration protein solutions, facilitating their handling during manufacturing and administration processes. The dual functionality of L-Arginine in both stabilizing proteins and reducing viscosity makes it a versatile and valuable additive in the formulation of high-concentration protein-based products.

References/Citations:

 

Pfanstiehl Arginine Citation Page

 

Highest cGMP Compendial Quality for your Highest Risk Applications

Pfanstiehl Brand High Purity – Low Endotoxin – Low Metals

 

L-Arginine USP EP JP ChP

 

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

 

Pfanstiehl Brand L-Arginine are compliant with USP EP JP and ChP pharmocopoeia.

 

Because of these stringent manufacturing specifications and quality systems, you can be assured that Pfanstiehl’s L-Arginine 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-Arginine (Plant Derived)

Quality Level:

Highest – Compendial Parenteral Excipient Grade GMP

Attributes:

Highest Purity

Lowest Endotoxin

Lowest Metals

Lowest Bioburden

Agency Pharmacopeia:

USP

EP

JP

ChP

Applications:

Parenteral Formulation

Liquid Formulation

Pharmaceutical Process

Biopharma Process

  • Product Name:

    L-Arginine (Plant Derived)

  • Quality Level:

    Highest – Compendial Parenteral Excipient Grade GMP

  • Attributes:

    Highest Purity

    Lowest Endotoxin

    Lowest Metals

    Lowest Bioburden

  • Agency Pharmacopeia:

    USP

    EP

    JP

    ChP

  • Applications:

    Parenteral Formulation

    Liquid Formulation

    Pharmaceutical Process

    Biopharma Process

Have Questions?

Please click the Contact Us box for:

  • Sample Requests

  • Price Quotes

  • Product Information

  • Quality Documentation

  • General Questions

Need Large Volumes?

10KG, 25KG, 50KG Pack Sizes Available – Contact Us for quote

What can we help you find?