Pharmaceutical Grade Citric Acid, National Medicine Permit Number API, 500g per Bottle

Citric acid is an organic acid widely used in pharmaceuticals, food, and industrial fields. In pharmaceutical preparations, it is primarily used as an acidity regulator, chelating agent, and buffer. The "Chinese Pharmacopoeia 2020 Edition" (CP Edition) specifies detailed quality standards for pharmaceutical grade citric acid to ensure its safety and effectiveness in drug applications.

1. Properties of Citric Acid

- Molecular formula: C?H?O?.

- Molecular weight: 192.12.

- Appearance: Colorless transparent crystals or white crystalline powder with a sour taste, easily soluble in water and ethanol.

- Main uses: Citric acid is widely used in pharmaceuticals as a buffer, pH regulator, and solubilizing agent, particularly suitable for the preparation of injections, oral solutions, and tablets.

2. Quality Standards

According to the "Chinese Pharmacopoeia 2020 Edition," pharmaceutical grade citric acid must meet the following specifications:

- Appearance: Should be white crystals or colorless transparent crystals with no obvious impurities.

- Assay: Citric acid content must be between 99.5% and 100.5% (calculated on a dried basis), ensuring high purity.

- Acidity: The pH of a 0.1g aqueous solution of citric acid should be between 1.8 and 2.2.

- Moisture: Not more than 1%.

- Heavy metals limit: Not more than 10 ppm.

- Chlorides: Content not more than 50 ppm.

- Sulfates: Content not more than 150 ppm.

- Oxalates: Content must not exceed the range specified by the pharmacopoeia.

- Loss on drying: Not more than 1.0%.

- Residue on ignition: Not more than 0.05%.

3. Functions and Roles in the Pharmaceutical Field

- pH regulation: Controls and stabilizes pH in pharmaceutical preparations.

- Solubilization: Forms salts with certain drug components to improve solubility.

- Antioxidant effect: Delays drug oxidation by chelating metal ions.

- Excipient: Provides necessary physical and chemical stability for tablets and oral solutions.

Pharmaceutical Grade Citric Acid, National Medicine Permit Number API, 500g per Bottle

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