Adopting pharmaceutical-grade synthesis process and multiple recrystallization purification, the purity is as high as 99.5%, and the impurity content is far lower than the pharmacopoeia limits. It is produced strictly in accordance with cGMP standards, and each batch is provided with a third-party test report to ensure product quality controllability. The packaging adopts moisture-proof aluminum cans or cardboard drums, which effectively prevent contamination and moisture, ensuring the sterility of the product. It has excellent buffer performance, which can stably adjust the pH value of the drug solution and avoid degradation of the drug solution during storage. At the same time, as a chelating agent, it can effectively remove metal ion impurities in the drug solution, improving the stability and safety of the drug.
Particle size: 0.25-0.42mm; Moisture content: 36.2-38.8% (trihydrate type); Chloride content: ≤0.005%; Sulfate content: ≤0.003%; Lead content: ≤0.0002%; Arsenic content: ≤0.0001%; Bulk density: 0.95-1.05g/cm³; Dissolution speed: completely dissolved in water at 25℃ within 8 minutes; Packaging specification: 5kg aluminum foil can, 25kg pharmaceutical cardboard drum; Storage conditions: cool and dry place, avoid contact with strong acids and strong oxidants; Shelf life: 36 months.
It is applicable to the production of pharmaceutical products such as injectable powder injections, infusion preparations, oral solutions, ophthalmic drugs, external ointments, etc. As a pH buffer regulator, it can stabilize the pH value of the drug solution, improve the shelf life and effectiveness of the drug. At the same time, as a chelating agent, it can be used in protein purification, enzyme preparation preservation and other scenarios in the field of biopharmaceuticals, and is an indispensable pharmaceutical excipient in the pharmaceutical industry.
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