Monobasic sodium phosphate monohydrate USP/BP PARENTEX PLUS – Premium buffering and pH-adjusting excipient, optimizing API stability

1. General Introduction to Monobasic sodium phosphate monohydrate PARENTEX PLUS

Monobasic sodium phosphate monohydrate USP/BP PARENTEX PLUS (Sodium dihydrogen phosphate monohydrate) is a high-quality excipient that plays a core role as an effective pH adjuster and buffering agent in the pharmaceutical and medical device industries. Unlike conventional compounds, the PARENTEX PLUS product line is optimally designed with ultra-high purity and strict control over inorganic impurities as well as bacterial endotoxins. This helps protect and maintain the physicochemical stability of sensitive active ingredients, minimizing irritation at the site of administration.

The raw material is manufactured by Aceto Pharma (India) Pvt Ltd (India), a leading reputable manufacturer in India in the field of excipients and specialized pharmaceutical ingredients. The product strictly complies with international pharmacopeial standards (USP/BP), perfectly meeting the stringent requirements of production lines for intravenous injections, ophthalmic solutions, oral medications, and premium dietary supplements.

2. Raw Material Information: Monobasic sodium phosphate monohydrate PARENTEX PLUS

• Material Name: Monobasic sodium phosphate monohydrate USP/BP PARENTEX PLUS (Sodium dihydrogen phosphate monohydrate form)
• Manufacturer: Aceto Pharma (India) Pvt Ltd
• Origin: India
• Material Category: Pharmaceutical Excipient / pH Adjuster / Buffering Agent.
• Function: Establishes and maintains the optimal stable pH range for formulations, stabilizes active pharmaceutical ingredients (APIs), acts as an excipient to supplement Phosphorus, and supports the solubility and bioavailability of APIs.
• Chemical Composition: Sodium dihydrogen phosphate monohydrate ($NaH_2PO_4 \cdot H_2O$).
• Physical Form: White crystalline powder or colorless crystals, practically odorless, with a slightly saline or acidic taste.
• Solubility: Very soluble in water, forming a clear solution; practically insoluble in ethanol.
• Quality Standards: Meets United States Pharmacopeia (USP) and British Pharmacopoeia (BP) standards with strict control criteria.

The material is strictly controlled for:

• Purity & Assay: Achieves an accurate content of 98.0% – 103.0% according to pharmacopeial standards.
• Heavy Metals & Inorganic Impurities Limits: Strict control of Arsenic, Lead, Iron, Chloride, and Sulfate levels at extremely low limits.
• Bacterial Endotoxins: Subject to exceptionally strict control, ensuring absolute safety when applied in sterile injectable dosage forms.
• Clarity and Color of Solution: The solution after dissolving must be completely clear, colorless, and free of foreign particles.

3. Outstanding Advantages of PARENTEX PLUS

• Parenteral-grade Purity: The PARENTEX PLUS line is refined using advanced technology, removing most trace impurities to meet the standards for manufacturing parenteral preparations.
• Excellent Buffering Capacity: Helps maintain a stable pH value of the drug solution, minimizing the hydrolysis or denaturation of APIs caused by pH changes during storage.
• High Physicochemical Stability: The monohydrate salt form has stable physical and mechanical properties, making it less prone to deliquescence or caking under standard storage conditions, thereby increasing the shelf life and quality of the finished product.
• Compatibility and Versatility: Easy to mix and highly compatible with other phosphate buffers to create desired pH ranges from neutral to slightly acidic.

4. Applications of Monobasic sodium phosphate monohydrate

In Pharmaceuticals

• Buffer for Injections and Infusions: An essential component to adjust the pH of intravenous and intramuscular injections, and electrolyte infusions, helping to reduce pain and tissue necrosis at the injection site.
• Ophthalmic and Nasal Solutions: Maintains an isotonic pH, biologically compatible with the tear film and nasal mucosa, preventing mucosal irritation.
• Oral Liquids and Syrups: Stabilizes flavors and active ingredients in syrup and oral solution formulations.
• Solid Dosage Forms: Used as a stabilizer or bulking agent for tablets and capsules.

In Dietary Supplements and Clinical Nutrition

• Clinical Nutrition: A component for Phosphorus and Sodium supplementation in total parenteral nutrition (TPN) solutions or hemodialysis solutions.
• Dietary Supplements: Provides essential minerals, supports metabolism, and maintains electrolyte balance.

5. Commercial Products Using Monobasic sodium phosphate monohydrate

6. Product Contact Information

For more information regarding the supply chain and technical specifications of Monobasic sodium phosphate monohydrate USP/BP PARENTEX PLUS, or to place an order, please contact us:

• Consulting Hotline: +84 (0) 834 560 500
• Email: director@biorichgroup.com
• Website:www.biorichgroup.com
• Sample/COA Request: Please contact us via email to request testing samples and the latest Certificate of Analysis (COA) for the raw material from the manufacturer, Aceto Pharma (India) Pvt Ltd.