Dibasic Sodium Phosphate Heptahydrate USP PARENTEX 500GM – Dedicated pH buffer system for parenteral formulations
1. General introduction to Dibasic Sodium Phosphate Heptahydrate USP PARENTEX 500GM
Dibasic Sodium Phosphate Heptahydrate USP PARENTEX 500GM is the dibasic sodium phosphate salt in its heptahydrate form, with the chemical formula Na₂HPO₄·7H₂O. It is an inorganic compound presented as a white crystalline powder, odorless, highly soluble in water, and mildly hygroscopic under ambient conditions.
The product is imported and manufactured in compliance with USP (United States Pharmacopeia) standards, one of the most widely recognized pharmaceutical compendia globally and is marketed under the PARENTEX brand, a product line specifically positioned for injectable and infusion formulation applications.
Dibasic Sodium Phosphate Heptahydrate USP PARENTEX 500GM is primarily used as a buffering and pH-adjusting excipient in pharmaceutical formulations, biopharmaceuticals, medical cosmetics, and nutraceutical products. The 500GM packaging format is suitable for both research and development (R&D) and pilot-scale GMP manufacturing.
2. Active composition of Dibasic Sodium Phosphate Heptahydrate USP PARENTEX
PARAMETER
SPECIFICATION
Chemical name
Disodium hydrogen phosphate heptahydrate
Molecular formula
Na₂HPO₄·7H₂O
Molecular weight
268.07 g/mol
Assay (USP)
98.0% – 102.0% (calculated on anhydrous basis)
pH (1% w/v solution)
8.9 – 9.2
Effective buffer range
pH 5.8 – 8.0 (with NaH₂PO₄)
Second pKa (phosphate system)
7.2 (physiological pH region)
Quality standards
USP, Ph.Eur., BP
Bacterial endotoxins
≤ 0.5 EU/mg (parenteral grade, LAL tested)
Solubility in water
~268 g/L at 25°C
Appearance
White crystalline, odorless powder
Packaging
500 GM / container
3. Key advantages of Dibasic Sodium Phosphate Heptahydrate USP PARENTEX
Physiologically relevant phosphate buffer system: With a second pKa of 7.2, it closely matches human physiological pH (7.0–7.4), ensuring optimal buffering performance in biologically critical environments.
USP-grade compliance for global regulatory readiness: Fully compliant with USP testing requirements, including identification, assay, chloride, sulfate, arsenic, heavy metals, and pH specifications.
Controlled endotoxin levels for injectable applications: Endotoxin level ≤ 0.5 EU/mg, verified by LAL testing, ensuring safety for parenteral formulations and minimizing pyrogenic risk.
Chemical stability for formulation protection: Maintains target pH stability during dilution, temperature variation, and sterilization processes, supporting long-term product stability.
High compatibility across complex formulations: Compatible with biologics, monoclonal antibodies, vaccines, small-molecule APIs, and common excipients such as mannitol, glycerol, and polysorbates.
GMP-suitable heptahydrate form: Controlled hygroscopicity, stable at 15–25°C, rapid dissolution in Water for Injection (WFI), and easy handling in controlled manufacturing environments.
4. Applications of Dibasic Sodium Phosphate Heptahydrate USP PARENTEX
Pharmaceutical Applications
Intravenous infusion formulations: Maintains physiological pH (7.0–7.4), reduces API precipitation, minimizes vascular irritation, and ensures biocompatibility.
Ophthalmic preparations: A gold-standard buffering system in eye drops due to tear-compatible pH (~7.4), improving ocular tolerance and bioavailability.
Biopharmaceuticals & monoclonal antibodies: Provides optimal buffering (pH 6.5–7.5) to preserve tertiary and quaternary protein structures, preventing aggregation and denaturation during manufacturing, sterile filtration, and lyophilization.
Vaccines (viral, protein subunit, and mRNA vaccines): Widely used as a stabilizing buffer system in vaccine formulations including influenza, hepatitis B, recombinant protein, and next-generation mRNA platforms.
Surgical irrigation & tissue preservation solutions: Used in phosphate-buffered saline (PBS) systems for wound irrigation, tissue preservation, and cell culture environments.
Lyophilized injectable products: Supports pH control in pre-lyophilization formulations and maintains cake integrity after reconstitution.
Medical Cosmetics (Cosmeceuticals)
Artificial tears and ophthalmic cosmetic solutions with physiological pH compatibility and low irritation potential.
Stabilization of sensitive actives such as vitamin C, retinol, and niacinamide in aqueous gel and lotion systems.
Nutraceuticals & Clinical Nutrition
Parenteral nutrition (TPN): Provides essential phosphate supplementation for electrolyte balance and prevention of hypophosphatemia in critically ill patients.
Liquid supplements & medical beverages: Stabilizes pH in protein drinks, sports nutrition formulations, and oral rehydration solutions.
5. Product contact information
For further information regarding the supply of Dibasic Sodium Phosphate Heptahydrate USP PARENTEX 500GM, please contact:
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