Dibasic sodium phosphate dihydrate USP/Ph.Eur/BP PARENTEX – high reproducibility pH buffer excipient for pH-sensitive formulations
1. General Introduction to Dibasic Sodium Phosphate Dihydrate USP/Ph.Eur/BP PARENTEX
Dibasic Sodium Phosphate Dihydrate USP/Ph.Eur/BP PARENTEX is a pharmaceutical-grade pH buffering excipient engineered for pH-sensitive formulations that require high stability. It is widely used in injectable drugs, peptide formulations, effervescent tablets and advanced dosage forms.
This product is typically used when:
Formulations exhibit pH drift between batches
Scale-up leads to variability in results
APIs are highly dependent on pH conditions
2. Composition of Dibasic Sodium Phosphate Dihydrate USP/Ph.Eur/BP PARENTEX
Chemical formula:Na₂HPO₄·2H₂O
Function: pH buffering excipient
Standards: USP / Ph.Eur / BP
The dihydrate form helps maintain equilibrium stability in solution, reducing pH fluctuations during manufacturing.
3. Key advantages of Dibasic Sodium Phosphate Dihydrate USP/Ph.Eur/BP PARENTEX
High batch-to-batch pH reproducibility
Predictable buffering behavior during scale-up
Reduced risk of API degradation
Enhanced stability for pH-sensitive formulations
Strong support for regulatory documentation and submissions
4. Applications of Dibasic Sodium Phosphate Dihydrate USP/Ph.Eur/BP PARENTEX
Pharmaceutical Applications
Injectable formulations (buffer systems):Maintain stable pH in parenteral solutions, minimizing precipitation and API degradation; commonly used in injectable antibiotics, anesthetics, and peptide drugs
Peptide / biologics: Stabilize microenvironmental pH to preserve structural integrity and biological activity, reducing potency loss during storage
Premium effervescent tablets: Precisely control acid–base reaction rates, ensuring consistent dissolution performance across batches
Modified-release (MR/CR) tablets: Stabilize the dissolution pH environment, supporting consistent drug release profiles
Premium Cosmetic Applications
Vitamin C / peptide serums: Stabilize pH to reduce oxidation and maintain active efficacy throughout the product lifecycle
pH-sensitive skincare products: Prevent discoloration and reduce degradation of sensitive actives such as AHA, BHA, and vitamins
High-end cosmetics: Extend shelf life and ensure batch-to-batch consistency
Dietary Supplement Applications
Functional beverages: Maintain stable pH to preserve taste and product stability throughout shelf life
Export products: Ensure batch consistency to meet international market requirements
pH-sensitive supplements:Stabilize the formulation environment to preserve potency of vitamins, minerals, and bioactive compounds
5. Commercial Products Using Dibasic Sodium Phosphate Dihydrate USP/Ph.Eur/BP PARENTEX
6. Product contact Information
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