Product Description
Sulfamethoxazole isA an oral sulfonamide antibiotic, given in combination with trimethoprim, used to treat a variety of infections of the urinary tract, respiratory system, and gastrointestinal tract. Bactrim, Septra, Sulfatrim.Strict Pharmacopeial ComplianceSULFAMETHOXAZOLE IP BP USP is manufactured to fully comply with IP/BP/USP standards, including comprehensive identification, purity, residue on ignition, and control of related substances. This rigorous adherence ensures the product is reliable and consistent in pharmaceutical applications, offering peace of mind to manufacturers and healthcare professionals.
Superior Purity and StabilityWith an assay of 99.0% to 101.0% and very low levels of impurities or heavy metals, SULFAMETHOXAZOLE IP BP USP maintains high efficacy and safety. Its shelf life of 60 months and resistance to degradation make it a preferred choice for long-term storage and use in medicinal formulations.
Versatile Antibacterial ApplicationThis API finds wide utility in combinatory antibacterial therapies, most notably paired with trimethoprim. Its robust activity spectrum helps combat bacterial infections efficiently, supporting the development of effective and trusted pharmaceuticals for global markets.
FAQ's of SULFAMETHOXAZOLE IP BP USP:
Q: How is SULFAMETHOXAZOLE IP BP USP typically used in pharmaceutical applications?
A: SULFAMETHOXAZOLE IP BP USP is employed as an active pharmaceutical ingredient, primarily in the formulation of antibacterial medications, notably in combination with trimethoprim to enhance therapeutic efficacy against bacterial infections.
Q: What quality standards does SULFAMETHOXAZOLE IP BP USP comply with?
A: This product complies with the identification, purity, and related substances standards described in the Indian, British, and United States Pharmacopeias (IP/BP/USP), ensuring the highest quality suitable for pharmaceutical manufacturing.
Q: When should SULFAMETHOXAZOLE IP BP USP be stored to maintain its quality?
A: It should be stored in a well-closed container, away from light and moisture. Under recommended storage conditions, the ingredient remains stable for up to 60 months from the date of manufacture.
Q: What are the benefits of using SULFAMETHOXAZOLE IP BP USP with high assay and low impurities?
A: High assay values (99.0%-101.0%) and minimal impurities or heavy metals ensure greater safety, efficacy, and consistency in finished pharmaceutical products, reducing risk and improving patient outcomes.
Q: Where does the product packaging process take place, and can it be customized?
A: Packaging is typically done in HDPE drums to safeguard product integrity, but customization is available as per specific customer requirements, catering to various logistics or regulatory preferences.
Q: What is the significance of the product's physical and chemical characteristics?
A: Its white crystalline appearance, odorless nature, specific melting point, and solubility profile play key roles in manufacturing processes, formulation stability, and drug delivery performance.
Q: How is the microbial quality of SULFAMETHOXAZOLE IP BP USP assured?
A: The product meets all pharmacopeial microbial limit tests, ensuring safety for therapeutic use by limiting potential contaminants throughout manufacturing and packaging.