Delivering on the Promise of Purity

Delivering on the Promise of PurityTM

Sodium Gluconate USP Molecular Structure used as buffering agent in Large Volume Parenterals.

Sodium Gluconate USP

Sodium Gluconate, High Purity, Low Endotoxin, Low Metals, USP

Molecular Formula

C6H12O7 • Na

CAS No

527-07-1

Molecular Weight

219.15

Solubility in Water

590 g/L at 25°C

Boiling Point

N/A – decomposes

Melting Point

200 – 206°C

Quality Level

Highest – Parenteral Excipient Grade cGMP

Suitable for Injectable Biologic & Vaccine Formulations

Sodium gluconate is a sodium salt of gluconic acid, which is derived from glucose through a simple fermentation process. It is a white crystalline powder that is highly soluble in water.

Pfanstiehl Sodium gluconate is used in Large Volume Parenterals (LVP) and serves several purposes:

Electrolyte Agent

In Large Volume Parenterals, Sodium gluconate provides sodium ions (Na⁺), which are essential for maintaining electrolyte balance in the body. Sodium is one of the key electrolytes responsible for maintaining fluid balance, nerve function, and muscle contraction. In LVPs, it helps replenish sodium levels in the body, especially in situations where there is a deficit due to dehydration, electrolyte imbalances, or other medical conditions.

 

Buffering Agent

Sodium gluconate can effectively act as a buffering agent due to its ability to maintain a stable pH level in parenteral pharmaceutical formulations.

 

pH Regulation: Sodium gluconate possesses buffering capacity within a specific pH range, typically around pH 6 to 8, making it suitable for many pharmaceutical applications where this pH range is desirable.

pH Stability: It helps to resist changes in pH by neutralizing acidic or basic compounds that may be present in the formulation. This ensures that the pH remains within the desired range, which is crucial for maintaining the stability and efficacy of the pharmaceutical product.

 

Compatibility

Sodium gluconate is compatible with many other pharmaceutical ingredients commonly found in Large Volume Parenteral formulations. Its compatibility ensures that the solution remains homogeneous and does not precipitate or form insoluble complexes.

 

Excipient

Sodium gluconate can be used as an excipient, a substance added to a pharmaceutical formulation to improve its properties. It can enhance the stability, solubility, and bioavailability of therapeutics.

References/Citations:

Highest cGMP Compendial Quality for your Highest Risk Applications

Pfanstiehl Brand High Purity – Low Endotoxin – Low Metal Sodium Gluconate was developed specifically for biopharmaceutical formulation and commercial manufacturing and is produced under full cGMP conditions in the United States to the highest quality and purity standards.

 

Pfanstiehl Brand Sodium Gluconate is compliant with the USP monograph established in 2017 and available as USP (United States Pharmacopoeia)

 

Because of stringent quality systems and manufacturing specifications, you can be assured that Pfanstiehl’s Sodium Gluconate 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:

Sodium Gluconate

Quality Level:

Highest – Compendial Parenteral Excipient Grade GMP

Attributes:

Highest Purity

Lowest Endotoxin

Lowest Metals

Lowest Bioburden

Agency Pharmacopeia:

USP

Applications:

Large Volume Parenteral Formulation

  • Product Name:

    Sodium Gluconate

  • Quality Level:

    Highest – Compendial Parenteral Excipient Grade GMP

  • Attributes:

    Highest Purity

    Lowest Endotoxin

    Lowest Metals

    Lowest Bioburden

  • Agency Pharmacopeia:

    USP

  • Applications:

    Large Volume Parenteral Formulation

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