D-Mannitol USP EP BP JP ChP

Benefits of Pfanstiehl (HPLE-LM)^TM D-Mannitol Excipient in Biologics Formulations:

Stabilization of Proteins

D-Mannitol is known to stabilize proteins in both liquid and lyophilized (freeze-dried) formulations. It helps to prevent protein aggregation and denaturation, which can occur during manufacturing and storage.

Cryoprotectant and Lyoprotectant:

In freeze-drying processes, D-Mannitol acts as a cryoprotectant and lyoprotectant. It protects the biological molecules from damage caused by freezing and drying stresses, ensuring the integrity and activity of the biologic product.

Osmotic Agent

D-Mannitol is an effective osmotic agent, which helps in controlling the osmotic pressure in formulations. This is particularly important in maintaining the stability and efficacy of biologics during storage and administration.

Bulking Agent

It serves as a bulking agent in lyophilized formulations, providing structure and ensuring that the final product has a uniform and acceptable appearance.

Solubility and Compatibility

D-Mannitol is highly soluble in water, making it easy to formulate into liquid preparations. It is also compatible with a wide range of active pharmaceutical ingredients (APIs) and other excipients, enhancing its versatility in different formulations.

Safety and Tolerability

D-Mannitol is generally recognized as safe (GRAS) by regulatory authorities like the FDA. It is well-tolerated by patients, with minimal side effects when used in appropriate amounts.

Pfanstiehl Brand High Purity Low Endotoxin Low Metals (HPLE-LM)^TM Mannitol was developed specifically for biopharmaceutical use and is produced under full cGMP conditions in the United States to the highest quality and purity standards.

Because of stringent quality systems and manufacturing specifications, you can be assured that Pfanstiehl’s (HPLE-LM)^TM D-Mannitol will be of the highest quality & consistency from batch to batch and the safest product available for use in your manufacturing or research application.