Sodium Citrate Dihydrate – International Standard pH Adjuster and Anticoagulant Excipient
1. General Introduction to Sodium Citrate Dihydrate
Sodium Citrate Dihydrate (Trisodium citrate dihydrate) is the sodium salt of citric acid, distinguished by its ability to act as a superior buffering agent that stabilizes pH and offers high biological safety. This active ingredient is widely used both as a primary therapeutic agent (anticoagulant, urine alkalizer) and as a multifunctional excipient in pharmaceuticals, healthcare, and the food industry.
The raw material is manufactured by Sujata Nutri-Pharma Pvt. Ltd. (India), a globally reputable manufacturer with international quality certifications. Through an advanced purification process, Sujata Nutri-Pharma's Sodium Citrate Dihydrate achieves optimal purity with strict control over heavy metal indicators, ensuring complete batch-to-batch consistency and meeting the most stringent pharmacopeial standards.
2. Raw Material Information
Material Name: Sodium Citrate Dihydrate / Trisodium Citrate Dihydrate
Manufacturer: Sujata Nutri-Pharma Pvt. Ltd.
Origin: India
Material Group: Pharmaceutical Excipients / Active Pharmaceutical Ingredients (API).
Chemical Composition: Molecular formula Na3C6H5O7·2H2O.
Form: Crystalline powder or white granular crystals, odorless, with a salty and slightly tart taste.
Solubility: Freely soluble in water, practically insoluble in alcohol (ethanol).
Quality Standards: Complies with United States Pharmacopeia (USP), European Pharmacopoeia (EP), British Pharmacopoeia (BP), or Indian Pharmacopoeia (IP) standards.
The material is strictly controlled for:
Purity and Assay: Ensures the active ingredient content meets the standard of 99.0% - 100.5% (according to USP).
Heavy Metals and Impurities Limits: Strictly controls arsenic, lead, aluminum levels, etc., at extremely low thresholds, ensuring absolute safety for injectables and medical preparations.
Microbial Limits: Meets strict microbiological standards for oral and injectable preparations.
3. Advantages of Sujata Nutri-Pharma's Sodium Citrate Dihydrate
High Purity and Safety: The manufacturing process thoroughly eliminates harmful impurities, meeting the requirements of applications demanding the highest safety, such as infusion solutions and blood preservation.
Precise Mechanism of Action: Strong ability to form complexes with calcium ions (Ca2+), effectively inhibiting blood coagulation; meanwhile, the citrate/citric acid buffer system helps maintain a stable pH range for pharmaceutical solutions.
Superior Formulation Properties: Excellent chemical stability, not highly hygroscopic under normal conditions, and easily compatible with other active ingredients without causing incompatibilities.
Reasonable Cost - Stable Supply: Manufactured in India by Sujata Nutri-Pharma, providing optimal competitive pricing, acting as an effective solution for manufacturing plants to optimize production costs.
4. Applications of Sodium Citrate Dihydrate
In Pharmaceuticals and Healthcare (Core Applications)
Anticoagulant: Widely used in blood collection tubes, intravenous blood storage bags, and platelet preservation solutions due to its calcium-chelating mechanism.
Urinary Tract Medications: Acts as the main active ingredient in urine alkalizers, supporting the treatment of mild cystitis and alleviating symptoms of urinary tract infections.
Buffering Agent and pH Adjuster: Used in formulations for infusions, cough syrups, and eye drops, helping to stabilize pH and protect drugs from degradation.
In Health Supplements and F&B
Rehydration and Electrolytes: An essential component in ORS (Oral Rehydration Salts) packets and sports drinks to replenish sodium.
Flavor Enhancer and Preservative: Acts as an acidity regulator, color retainer, and synergistic antioxidant (combined with Vitamin C) in beverages, dairy products, and functional foods.
5. Commercial Products Using Sodium Citrate Dihydrate
6. Product Contact Information
For further information on the supply chain, technical specifications of Sodium Citrate Dihydrate, or to place an order, please contact us:
Sample/COA Request: Please contact us via email to request a sample and the latest Certificate of Analysis (COA) for the raw material from the manufacturer, Sujata Nutri-Pharma Pvt. Ltd.
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