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| Product Name | Citric Acid 1-hydrate |
| Grade | Pharma Grade |
| Standards | N/A |
| Purity | Pure |
| Appearance | White crystalline powder |
| Chemical Formula | C6H8O7.H2O |
| CAS Number | 5949-29-1 |
| Molecular Weight | 210.14 g/mol |
| Solubility | Soluble in water |
| Uses | N/A |
| Storage | Store in a cool, dry place away from moisture and heat |
FAQ
What is Citric Acid 1-hydrate and why is it considered pharmaceutical grade?
Citric Acid 1-hydrate is a crystalline powder form of citric acid that contains one molecule of water per citric acid molecule. It is widely used in various pharmaceutical formulations due to its high purity and quality standards. Pharmaceutical grade citric acid undergoes rigorous testing to ensure it meets the strict standards set forth by regulatory bodies such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP).
What are the common applications of Citric Acid 1-hydrate in the pharmaceutical industry?
Citric Acid 1-hydrate is commonly used in the pharmaceutical industry as an excipient in tablet formulations, as a buffering agent in liquid preparations, and as a preservative in parenteral solutions. It is also used in the production of effervescent granules and tablets due to its effervescent properties. Additionally, citric acid can be used to adjust the pH of certain formulations and to improve the stability of active pharmaceutical ingredients.
What are the key benefits of using USP, BP, Ph. Eur., and JP compliant Citric Acid 1-hydrate in pharmaceutical applications?
Using USP, BP, Ph. Eur., and JP compliant Citric Acid 1-hydrate ensures that the product meets the highest standards of purity, quality, and safety. This is crucial in the pharmaceutical industry where strict regulatory requirements must be met to ensure the efficacy and safety of the final product. By using compliant citric acid, pharmaceutical manufacturers can have confidence in the consistency and reliability of their formulations.
How is Citric Acid 1-hydrate typically manufactured and what are some quality control measures in place to ensure its purity?
Citric Acid 1-hydrate is typically manufactured through a fermentation process using natural sources such as sugar beets or corn. After fermentation, the citric acid is purified through crystallization and filtration to remove impurities and water molecules. Quality control measures such as chromatographic analysis, spectroscopic analysis, and microbial testing are employed to ensure the purity and quality of the final product. Additionally, batch-to-batch consistency is maintained through strict adherence to standard operating procedures and Good Manufacturing Practices (GMP).
Are there any specific storage and handling requirements for Citric Acid 1-hydrate to maintain its stability and quality?
Citric Acid 1-hydrate should be stored in a dry, cool, and well-ventilated area away from direct sunlight and moisture. It should be kept in its original packaging or in a tightly sealed container to prevent contamination and degradation. Proper handling practices should be followed to avoid spills and exposure to skin and eyes. Additionally, regular inspections should be conducted to check for signs of deterioration such as discoloration, caking, or odors.
Citric Acid 1-hydrate is a crystalline powder form of citric acid that contains one molecule of water per citric acid molecule. It is widely used in various pharmaceutical formulations due to its high purity and quality standards. Pharmaceutical grade citric acid undergoes rigorous testing to ensure it meets the strict standards set forth by regulatory bodies such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP).
What are the common applications of Citric Acid 1-hydrate in the pharmaceutical industry?
Citric Acid 1-hydrate is commonly used in the pharmaceutical industry as an excipient in tablet formulations, as a buffering agent in liquid preparations, and as a preservative in parenteral solutions. It is also used in the production of effervescent granules and tablets due to its effervescent properties. Additionally, citric acid can be used to adjust the pH of certain formulations and to improve the stability of active pharmaceutical ingredients.
What are the key benefits of using USP, BP, Ph. Eur., and JP compliant Citric Acid 1-hydrate in pharmaceutical applications?
Using USP, BP, Ph. Eur., and JP compliant Citric Acid 1-hydrate ensures that the product meets the highest standards of purity, quality, and safety. This is crucial in the pharmaceutical industry where strict regulatory requirements must be met to ensure the efficacy and safety of the final product. By using compliant citric acid, pharmaceutical manufacturers can have confidence in the consistency and reliability of their formulations.
How is Citric Acid 1-hydrate typically manufactured and what are some quality control measures in place to ensure its purity?
Citric Acid 1-hydrate is typically manufactured through a fermentation process using natural sources such as sugar beets or corn. After fermentation, the citric acid is purified through crystallization and filtration to remove impurities and water molecules. Quality control measures such as chromatographic analysis, spectroscopic analysis, and microbial testing are employed to ensure the purity and quality of the final product. Additionally, batch-to-batch consistency is maintained through strict adherence to standard operating procedures and Good Manufacturing Practices (GMP).
Are there any specific storage and handling requirements for Citric Acid 1-hydrate to maintain its stability and quality?
Citric Acid 1-hydrate should be stored in a dry, cool, and well-ventilated area away from direct sunlight and moisture. It should be kept in its original packaging or in a tightly sealed container to prevent contamination and degradation. Proper handling practices should be followed to avoid spills and exposure to skin and eyes. Additionally, regular inspections should be conducted to check for signs of deterioration such as discoloration, caking, or odors.
