The IP provides detailed specifications to ensure the quality, potency, and safety of Flavoxate HCl for medicinal use:
Identification: Methods to confirm the presence and purity of Flavoxate HCl, ensuring it meets defined standards without contamination from other substances.
Assay: Quantitative determination of the potency of Flavoxate HCl, typically expressed as a percentage of the labeled amount, ensuring consistency in therapeutic efficacy.
Related Substances: Limits on impurities and degradation products to maintain purity and safety.
Residual Solvents: Maximum allowable levels of solvents used in manufacturing, ensuring the final product is free from harmful residues.
Loss on Drying: Measurement of moisture content to prevent degradation and ensure stability throughout storage and use.
Heavy Metals: Strict limits on toxic heavy metals such as lead, arsenic, mercury, and cadmium to ensure product safety.
Microbial Limits: Specifications ensuring the absence of harmful microorganisms, maintaining microbiological purity.
Particle Size Distribution: Requirements for particle size uniformity to optimize dissolution and absorption, enhancing bioavailability.
Uniformity of Dosage Units: Criteria ensuring consistent dosage across individual tablets or capsules, crucial for treatment efficacy.
Packaging: Specifications for materials and labeling that preserve the integrity and stability of Flavoxate HCl during storage and distribution.