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Specifications:
Appearance: It appears as white crystals, which is helpful for its initial visual identification.
Identification Method: Identified by infrared spectroscopy (IR). By analyzing the position and intensity of characteristic absorption peaks in the IR spectrum, the structure and composition of the substance can be accurately determined to confirm whether it is amoxicillin trihydrate.
Quality Indicators:
Assay: The content is in the range of 98.5% - 101%, indicating a high and stable purity and active ingredient content.
Water: The water content should be less than 0.5%. Excessive water may affect the product's stability, solubility, and efficacy.
Heavy Metals: The content of heavy metals is less than 20 ppm. Strict control of heavy - metal content reduces potential hazards to the human body and ensures the safety of medication.
Sulfated Ash: The sulfated ash is less than 0.1%, which reflects the content of inorganic impurities in the product.
Residue on Ignition: The residue on ignition is less than 0.1%, also used to measure the amount of inorganic impurities.
Loss on Drying: The loss on drying is less than 0.5%. Together with the water - content index, it monitors the water and volatile substances in the product.
pH Value: The pH is between 7.5 - 8.0. An appropriate pH is crucial for maintaining the product's chemical stability and its activity in the body.
Complying with latest pharmacopia BP/USP/WC certificate