Pfanstiehl pharmacopoeial grade excipient arginine glutamic acid

Pfanstiehl pharmacopoeial grade excipient arginine glutamic acid

In the field of innovative drug development, especially in high concentration protein formulations, the solubility and long-term stability of active ingredients (APIs) are key bottlenecks that determine the success or failure of the drug. With the development of the biopharmaceutical industryHigh concentration formulationThe continuous growth of demand has increasingly highlighted the problem of protein aggregation and precipitation in high concentration environments.Pfanstiehl's latest new pharmaceutical excipient A-172 (arginine glutamic acid) is designed to address the increasingly prominent formulation challenges in current biopharmaceutical research and development.

A-172 is formed by the ion binding of two natural amino acids, arginine and glutamic acid, in the human body. It is a structurally stable amino acid ion pair salt that can solve common problems such as low solubility, easy aggregation, and poor stability in high concentration protein preparations. Its zwitterionic properties can effectively interact with protein surfaces by improving hydrogen bonding and electrostatic interactions, forming stable ion pairs, significantly enhancing the solubility of protein drugs and inhibiting their aggregation, thereby ensuring the stability of high concentration formulations. Due to its composition of endogenous amino acids in the human body, A-172 has lower toxicity and better biocompatibility, making it particularly suitable for subcutaneous injection formulations that require frequent administration and high patient compliance requirements.

Why is A-172 arginine glutamic acid an excellent excipient for injectable biologics?

1. Reduce the viscosity of the formulation

A-172 helps regulate the osmotic pressure of injection solutions to physiological levels, improving the quality of the medicationRheological propertiesReduce solution viscosity and improve fluidity. This feature is particularly suitable for sensitive administration routes such as subcutaneous injection, which can reduce injection pain and tissue damage, while improving the processability of the formulation.

2. ImproveProtein solubility

A-172 can significantly enhance the solubility of poorly soluble drugs in aqueous systems, ensuring effective drug release and bioavailability in vivo. It exhibits good compatibility with peptides, proteins, antibodies, and small molecule chemical drugs, providing an ideal dissolution environment for protein drugs.

3. Reduce protein aggregation

By stabilizing the protein structure, A-172 can significantly reduce aggregation phenomena in high concentration protein preparations, ensure the activity of biological drugs, and ensure effectiveness and safety during storage and administration, which is crucial for maintaining the quality stability of biological preparations.

4. Reduce liquid-liquid separation

The natural buffering performance of A-172 can maintain the pH stability of the injection and prevent phase separation caused by pH drift. Its broad drug compatibility can maintain the uniformity of the formulation system, ensuring that the product maintains a stable physical state during storage.

5. Improve thermal stability

By inhibiting multiple stabilization mechanisms such as oxidation, aggregation, and pH drift, A-172 can significantly enhance the physical and chemical stability of injections, effectively extend product shelf life, and provide reliable protection for formulations under different storage conditions.

Pfanstiehl adheres to the consistent concept of high quality and has launched injection grade L-arginine L-Glutamate (A-172), which has the characteristics of ultra-high purity, ultra-low endotoxin, and ultra-low metal ion content. It can also detect DNA and RNA,DNA enzyme， RNAse, phosphatase, protease, lipase, nitrite, mycoplasma and other quality indicators can be used in the production and manufacturing of biopharmaceuticals and chemical drugs, especially in the field of injection preparations.

Product Features:

• Ultra high purity, ultra-low endotoxin, ultra-low microbial content;

• Low metal impurity residue, 29 metal ions were detected separately, all as low as ppb level;

• Detect DNA, RNA, DNAses, RNAses, phosphatases, proteases, lipases, and mycoplasma residues;

• Detecting nitrite residues;

• Detecting β - Glucans residues;

• Strictly follow the ICH-Q7 cGMP standard for production;

• Multiple packaging specifications to meet flexible applications from research and development to production.

Product application:

• PH buffer

• viscosity reducer

• stabilizer

• Promoting solvent

Product Information

Beijing Ximeijie Technology Co., Ltd. is Pfanstiehl's agent in China, providing customers with * technical support and after-sales service.