Monobasic sodium phosphate anhydrous IP/BP PARENTEX PLUS – High-quality buffering agent and pH adjuster for pharmaceuticals

1. General Introduction to Monobasic sodium phosphate anhydrous IP/BP PARENTEX PLUS

Monobasic sodium phosphate anhydrous is an essential inorganic excipient widely used in the pharmaceutical industry. Its core role is to act as a pH adjuster and buffering agent, helping to maintain the stability of active ingredients that are susceptible to degradation caused by acid-base environment changes in drug formulations. The PARENTEX PLUS product line is a premium excipient specially designed with outstanding purity, meeting the strictest requirements for sterile dosage forms.

The raw material is manufactured by Aceto Pharma (India) Pvt Ltd, a renowned manufacturer in India specializing in the provision of high-quality pharmaceutical excipients and chemicals. The product undergoes rigorous quality control to ensure maximum purity and ultra-low endotoxin levels, providing absolute safety for the production lines of infusions, eye drops, and specialized medical solutions.

2. Monobasic sodium phosphate anhydrous IP/BP PARENTEX PLUS Raw Material Information

• Raw Material Name: Monobasic sodium phosphate anhydrous IP/BP PARENTEX PLUS
• Manufacturer: Aceto Pharma (India) Pvt Ltd
• Origin: India
• Category: Pharmaceutical Excipient / Buffering agent / pH Adjuster.
• Function: Adjusts and maintains a stable pH, creates a buffer system, protects active ingredients from degradation, and provides phosphate ions.
• Chemical Formula: NaH₂PO₄.
• Appearance: White crystalline powder or white granules, odorless.
• Solubility: Very soluble in water, practically insoluble in ethanol.
• Quality Standard: Complies with Indian Pharmacopoeia (IP) and British Pharmacopoeia (BP) standards, Parenteral grade.

The material is strictly controlled for:

• Assay: Ensures the active ingredient content achieves high purity in accordance with Pharmacopoeial regulations.
• Bacterial Endotoxins: Controlled at ultra-low levels (a signature of the PARENTEX PLUS line), ensuring absolute safety when used as an excipient for injectables.
• Heavy Metals: Strict control of toxic metal impurities (such as Arsenic and Lead).
• Clarity and Color of Solution: Ensures the prepared solution is completely clear and free of mechanical impurities.

3. Advantages of Monobasic sodium phosphate anhydrous IP/BP PARENTEX PLUS

• Outstanding Buffering Capacity: Helps maintain a stable pH environment throughout the drug's shelf life, preventing the degradation of pH-sensitive active ingredients.
• Maximum Purity and Safety: The PARENTEX PLUS grade is specially refined to eliminate endotoxins and microbial impurities to the greatest extent possible, perfectly meeting the rigorous standards for sterile pharmaceuticals.
• Excellent Solubility: Very soluble in water, which helps to shorten mixing times and optimize industrial production efficiency.
• International Standards: Manufactured in India by Aceto Pharma, strictly complying with IP/BP Pharmacopoeia standards, which facilitates drug dossier registration across multiple international markets.

4. Applications of the Raw Material

In Pharmaceuticals (Core Applications)

• Parenteral Preparations: An indispensable buffering component in intravenous, intramuscular, and infusion formulations, ensuring the solution is biocompatible with blood pH and non-irritating.
• Ophthalmic Solutions: Adjusts the pH of eye drops to match the pH of natural tears, minimizing a stinging sensation and enhancing the stability of the active ingredient.
• Oral Solutions and Syrups: Used as a buffering agent or mineral (phosphorus) supplement in various oral solutions, syrups, or effervescent tablets.

In Other Medical and Nutritional Applications

• Bowel Cleansing Solutions: Combined with other phosphate salts to create osmotic laxative solutions for bowel preparation prior to colonoscopy procedures.
• Health Supplements: Used as a safe and effective source of mineral supplementation.

5. Commercial Products using Monobasic sodium phosphate anhydrous

6. Product Contact Information

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

• Advisory 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.