Delivering on the Promise of Purity

Delivering on the Promise of PurityTM

Arginine Glutamate Excipient Molecule for Viscosity Reduction

Arginine Glutamate

L-Arginine L-Glutamate - High Purity - Low Endotoxin - Low Metals - GMP

Molecular Formula

C11H23N5O6

CAS No

4320-30-3

Molecular Weight

321.34 g/mol

Solubility in Water

N/A

Boiling Point

N/A

Melting Point

N/A

Quality Level

Highest – Parenteral Excipient Grade GMP

Arginine glutamate is a compound composed of two naturally occurring amino acids: arginine and glutamic acid. These amino acids are combined to form a salt, known as an amino acid ionic pair, which is widely used in pharmaceuticals, especially as an excipient. Arginine glutamate is particularly valued in the formulation of parenteral (injectable) therapeutics due to its unique chemical and biological properties.

Why is Arginine Glutamate a Good Excipient for Parenteral (Injectable) Biologics?

The effectiveness of arginine glutamate as an excipient stems from several key properties that make it ideal for parenteral applications:

 

1. Solubility and Stabilization of Active Pharmaceutical Ingredients (APIs)

  • Enhanced Solubility: Arginine glutamate acts as a solubilizing agent, helping to dissolve hydrophobic or poorly soluble drugs in aqueous solutions. This is particularly important for parenteral formulations, where solubility is critical for ensuring drug bioavailability.
  • Stabilizing Effects: The salt form of arginine and glutamate can stabilize proteins and peptides by preventing aggregation. This is especially useful in biologics, such as monoclonal antibodies and other protein-based therapies.

 

2. Buffering Capacity

  • Arginine glutamate possesses a natural buffering capacity, helping to maintain the pH stability of injectable formulations. Stable pH is crucial for preventing degradation or denaturation of sensitive APIs, particularly in biologics.
  • The buffering effect also improves patient comfort by ensuring the pH of the injectable product is close to physiological levels, reducing irritation at the injection site.

 

3. Biocompatibility and Safety

  • Non-Toxic and Naturally Occurring: Both arginine and glutamate are endogenous amino acids found naturally in the body, reducing the risk of adverse reactions or toxicity.
  • Low Immunogenicity: Since it is composed of naturally occurring compounds, arginine glutamate is less likely to provoke immune responses, making it suitable for sensitive patient populations.

 

4. Prevention of Protein Aggregation

  • Arginine is known for its ability to reduce protein aggregation, a common challenge in parenteral formulations of biologics. Protein aggregation can decrease therapeutic efficacy and increase immunogenicity risks.
  • By stabilizing protein structures, arginine glutamate ensures the therapeutic remains effective and safe during storage and administration.

 

5. Osmolality Control

  • Arginine glutamate can help adjust the osmolality of injectable solutions, ensuring they are isotonic with human plasma. This minimizes the risk of adverse effects such as pain or irritation upon injection, especially in sensitive tissues.

 

6. Compatibility with a Wide Range of APIs

  • Arginine glutamate is chemically compatible with a variety of drug molecules, including peptides, proteins, and small molecules. Its versatility makes it a go-to excipient for different therapeutic classes.

 

7. Improved Shelf Life

  • The stabilizing properties of arginine glutamate contribute to the extended shelf life of parenteral formulations. By preventing oxidation, aggregation, or pH drift, it ensures the product remains effective and safe over its intended storage period.

 

Pfanstiehl Arginine glutamate is an excellent excipient option for parenteral injectable therapeutics due to its ability to enhance solubility, stabilize proteins, maintain pH, and prevent aggregation. Its biocompatibility, low toxicity, and versatility across various therapeutic modalities make it a valuable tool in pharmaceutical formulations.

References/Citations:

Highest cGMP Quality for your Highest Risk Applications:

Pfanstiehl Brand High Purity – Low Endotoxin – Low Metals

 

Arginine Glutamate

 

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

 

Because of these stringent manufacturing specifications and Pfanstiehl quality systems, you can be assured that Pfanstiehl’s Arginine Glutamate 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:

Arginine Glutamate

Quality Level:

Highest Quality

ICH-Q7 cGMP

Attributes:

Highest Purity

Lowest Endotoxin

Lowest Metals

Lowest Bioburden

Agency Pharmacopeia:

No active monographs exist

Pfanstiehl is sponsoring the USP monograph

Applications:

Parenteral Formulation

Liquid Formulation

Pharmaceutical Process

Biopharma Process

  • Product Name:

    Arginine Glutamate

  • Quality Level:

    Highest Quality

    ICH-Q7 cGMP

  • Attributes:

    Highest Purity

    Lowest Endotoxin

    Lowest Metals

    Lowest Bioburden

  • Agency Pharmacopeia:

    No active monographs exist

    Pfanstiehl is sponsoring the USP monograph

  • 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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