Delivering on the Promise of Purity

Delivering on the Promise of PurityTM

Mannitol USP EP JP ChP molecular structure used to stabilize protein therapeutics

D-Mannitol USP EP BP JP ChP

Molecular Formula

C6H14O6

CAS No

69-65-8

Molecular Weight

182.17g/mol

Solubility in Water

216000mg/L (at 25 °C)

Boiling Point

290°C

Melting Point

168°C

Quality Level

Highest – Parenteral Excipient Grade GMP

Suitable for Injectable Biologic & Vaccine Formulations

D-Mannitol is a type of sugar alcohol that is commonly used in the pharmaceutical and food industries. It is a white, crystalline powder that is naturally occurring and can be found in fruits, vegetables, and certain plants. D-Mannitol is often used as an excipient in pharmaceutical formulations, including biologics, due to its various beneficial properties.

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.

References/Citations:

Product Name:

D-Mannitol

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

Lyophilization

Cryoprotection

Spray-Drying

  • Product Name:

    D-Mannitol

  • 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

    Lyophilization

    Cryoprotection

    Spray-Drying

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