Monobasic potassium phosphate USP-NF/Ph.Eur/BP PARENTEX PLUS – Premium buffering agent, pH adjuster, and infusion mineral

1. General Introduction to Monobasic potassium phosphate PARENTEX PLUS

Monobasic potassium phosphate (also known as Potassium dihydrogen phosphate - KH₂PO₄) is an inorganic compound that plays a crucial role in the pharmaceutical industry. The PARENTEX PLUS product line is a specialized excipient refined to an ultra-pure grade, primarily used as a buffering agent to maintain and adjust a stable pH for pharmaceutical solutions, particularly parenterals and ophthalmic drugs.

The raw material is manufactured by Aceto Pharma (India) Pvt Ltd, a globally reputable manufacturer of pure active ingredients and excipients. The product undergoes rigorous quality control processes to ensure compliance with leading Pharmacopoeias (USP-NF, Ph.Eur, BP), with endotoxin and heavy metal levels controlled at extremely low limits, providing absolute safety for pharmaceutical formulations requiring high sterility.

2. Raw Material Information for Monobasic potassium phosphate PARENTEX PLUS

• Raw Material Name: Monobasic potassium phosphate (Potassium dihydrogen phosphate).
• Trade Name: PARENTEX PLUS.
• Manufacturer: Aceto Pharma (India) Pvt Ltd.
• Origin: India.
• Category: Pharmaceutical Excipient / Mineral Supplement.
• Function: Buffering agent, pH adjuster, source of Potassium and Phosphate ions in parenteral nutrition.
• Chemical Formula: KH₂PO₄.
• Form: White crystalline powder or colorless crystals, odorless.
• Solubility: Freely soluble in water, practically insoluble in ethanol.
• Quality Standards: Complies with the strictest Pharmacopoeial standards (USP-NF / Ph.Eur / BP).

The raw material is strictly controlled for:

• Bacterial Endotoxins: Controlled at ultra-low levels, meeting stringent standards for injections and intravenous infusions.
• Purity: Ensures accurate active ingredient content as stipulated by Pharmacopoeias.
• Heavy Metals & Inorganic Impurities Limits: Maximally eliminates toxic metals (such as Arsenic, Lead) to ensure physiological safety.
• Microbial Limits: Ensures absolute microbial cleanliness for sterile drug manufacturing.

3. Advantages of Monobasic potassium phosphate PARENTEX PLUS

• Superior buffering capacity: Helps stabilize the pH of pharmaceutical solutions throughout their shelf life, protecting sensitive Active Pharmaceutical Ingredients (APIs) from degradation caused by acidic or alkaline environments.
• High Bio-purity: The PARENTEX PLUS line is specifically designed for sensitive routes of administration such as intravenous, intramuscular, and ophthalmic use through the thorough control of endotoxins and microbes.
• Global compliance: Simultaneously meets multiple Pharmacopoeial standards (USP, Ph.Eur, BP), enabling pharmaceutical plants to easily export their end products to international markets.
• Perfect solubility: Easy to handle in large-scale production, yielding clear solutions without any suspended residues.

4. Applications of Monobasic potassium phosphate PARENTEX PLUS

In Pharmaceutical Manufacturing (Core Application)

• Parenterals: An indispensable ingredient in infusion solutions and lyophilized injections to stabilize pH and osmotic pressure.
• Ophthalmics: Used to create phosphate buffer systems, ensuring ophthalmic solutions have a pH compatible with natural tears, thereby minimizing irritation for patients.
• Oral Solutions and Syrups: Acts as a pH stabilizer in liquid pharmaceutical formulations.

In Clinical Nutrition & Biotechnology

• Total Parenteral Nutrition (TPN): Serves as a vital source of Potassium and Phosphate minerals for patients unable to tolerate gastrointestinal feeding, helping to prevent hypophosphatemia.
• Cell Culture & Vaccines: Acts as an ingredient in cell culture media and biological buffer solutions for the production of vaccines and biologics.

5. Commercial Products Using Monobasic potassium phosphate

6. Product Contact Information

For further information regarding the supply chain, technical specifications of Monobasic potassium phosphate USP-NF/Ph.Eur/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).