Dibasic Sodium Phosphate – Phosphate Buffer System for Microenvironment pH Control in Formulations

1. General introduction of Dibasic sodium Phosphate

Dibasic sodium phosphate is a versatile inorganic salt primarily serving as a buffering agent to adjust and maintain optimal pH levels (5.8 – 8.0) in parenteral solutions, ophthalmic drops, and lyophilized powder systems. Additionally, it functions as an tonicity adjusting agent, a mild chelating agent, and an active therapeutic agent (laxative, electrolyte replenisher).

Dibasic sodium phosphate belongs to a salt group with high hydration capability due to strong ion-dipole interactions between Na+ ions, phosphate ions (HPO42-), and water molecules. In pharmaceutical applications, this sodium salt is commonly utilized in the following hydrate forms:

• Dibasic sodium phosphate anhydrous: Na₂HPO₄
• Dibasic sodium phosphate monohydrate: Na₂HPO₄.H₂O
• Dibasic sodium phosphate dihydrate: Na₂HPO₄.2H₂O
• Dibasic sodium phosphate heptahydrate: Na₂HPO₄.7H₂O
• Dibasic sodium phosphate dodecahydrate: Na₂HPO₄.12H₂O

2. Material specifications of Dibasic sodium Phosphate 

Biorich's Dibasic Sodium Phosphate product lines comply with USP, EP, and BP pharmacopeial standards. In addition to standard quality parameters, the raw materials undergo strict control for Bacterial Endotoxins and microbiological limits, satisfying the stringent requirements of parenteral formulations, ophthalmic products, and other dosage forms.

3. Key advantage of Dibasic sodium Phosphate 

• Superior Buffering Capacity in Physiological pH Range: When combined with Monobasic Sodium Phosphate (NaH2PO4), the system forms a buffer solution with exceptional stability around the physiological range (pH∼7.4). Optimal pH control minimizes pain and irritation at the injection site or on ophthalmic mucosa.
• High Biocompatibility & Safety Profile: Phosphate (HPO42-) and sodium (Na+) ions are endogenous electrolytes of the biological internal environment. Officially documented in major Pharmacopeias (USP, Ph. Eur., JP) and included in the FDA Inactive Ingredients Database across multiple routes of administration: intravenous, ophthalmic, oral, and nasal.
• Versatility for Various Dosage Forms: Available in multiple hydration states with distinct physical properties, adapting flexibly to diverse pharmaceutical formulation types.
• Enhanced API Solubility and Chemical Stability: Maintaining a stable pH prevents hydrolysis reactions and enhances active pharmaceutical ingredient (API) solubility.
• High Chemical & Thermal Stability: In aqueous solutions, dibasic sodium phosphate remains thermally stable and withstands autoclave sterilization.

4. Application of Dibasic sodium Phosphate 

In Pharmaceuticals

• pH-Controlling Buffer System: Combined with Monobasic Sodium Phosphate to establish a phosphate buffer system (pH=5.8-8.0), preserving chemical stability for APIs and mitigating irritation in parenterals, eye drops, and nasal sprays.
• Lyophilization Stabilizer: Helps maintain the porous structure of lyophilized cakes and protects protein/peptide higher-order structures during freeze-drying.
• Laxatives & Electrolyte Replenishers: Serves as an active ingredient in rectal enemas or oral solutions intended for bowel preparation prior to colonoscopy.

In Food Industry

• Acidity Regulator & Buffering Agent: Maintains stable pH levels in beverages, dairy products, and processed foods.
• Emulsifying Agent: Prevents fat/water separation in cheese, yogurt, and other dairy derivatives.
• Anti-caking & Water-Retaining Agent: Helps retain moisture content and texture softness in processed meat and seafood products.

In Water Treatment & Industrial Applications

• Corrosion & Scale Inhibitor: Utilized in industrial boilers to precipitate heavy metal ions (Ca2+, Mg2+), preventing scale formation and protecting piping systems.
• Technical Cleaning Agent: Formulated into technical cleaning agents due to its water-softening capability.

 6. Product contact information

For more information regarding the supply of Dibasic Sodium Phosphate, please contact us:

• Hotline: +84 (0) 834 560 500
• Email: director@biorichgroup.com
• Website: www.biorichgroup.com
• Sample / COA Request: Please contact us via email to receive the latest Sample and Certificate of Analysis (COA).