Product Description
Luliconazole, trade names Luzu among others, is an imidazole antifungal medication. As a 1 Percent topical cream, It is indicated for the treatment of athletes foot, jock itch, and ringworm caused by dermatophytes such as Trichophyton rubrum, Microsporum gypseum and Epidermophyton floccosum.
Specification
|
Country of Origin
|
Made in India
|
|
Composition
|
Luliconazole
|
|
Packaging Size
|
25 Kg
|
|
Type of API
|
Anti Infective API
|
|
Pack Type
|
Bag
|
|
Prescription/Non prescription
|
Prescription
|
|
From
|
Powder
|
Superior Quality AssuranceLuliconazole Powder API is meticulously tested to meet high standards, such as a minimum assay of 99% by HPLC and total impurities not exceeding 1.0%. Every batch undergoes thorough identification processes, complying with USP/EP requirements, and is supported by a Certificate of Analysis. These measures guarantee reliability, safety, and efficacy for pharmaceutical applications.
Flexible Packaging and Supply ChainThe API is available in customizable sizes from 1g to 1kg, catering to both research and commercial needs. Logistics are managed expertly by distributors, exporters, and suppliers across India, ensuring timely delivery. Transport conditions are strictly controlledcontainers are kept tightly closed, and exposure to extreme temperatures is avoided to maintain product integrity.
Comprehensive Regulatory and Safety DocumentationEach shipment includes crucial documentation such as a Safety Data Sheet and a Certificate of Analysis. For regulatory purposes, Drug Master Files (DMF) are accessible on request. These resources facilitate seamless import, export, and registration processes, making Luliconazole Powder API a reliable choice for global pharmaceutical markets.
FAQs of Luliconazole Powder Api:
Q: How is the quality and purity of Luliconazole Powder API verified before distribution?
A: Quality and purity are validated using HPLC assay, confirming at least 99% content, alongside compliance with USP/EP identification standards and impurity profiling. Each batch undergoes rigorous pharmacopeial microbial testing and satisfies ICH Q3C guidelines for residual solvents, with results documented in the Certificate of Analysis.
Q: What packaging sizes are available for ordering Luliconazole Powder API, and can they be customized?
A: Luliconazole Powder API is offered in a variety of packaging options, including 1g, 5g, 10g, 100g, 500g, and 1kg sizes. Packaging can be customized based on specific customer requirements to suit both laboratory and commercial scale quantities.
Q: When and where is the Certificate of Analysis and Safety Data Sheet provided for this product?
A: The Certificate of Analysis is provided with every batch, detailing the analytical results and compliance status. A Safety Data Sheet is supplied upon request to guide safe handling and usage procedures throughout the supply chain.
Q: What are the recommended storage and transport conditions for Luliconazole Powder API?
A: The product should be kept in tightly closed containers and protected from extreme temperatures during transportation and storage to preserve its stability and quality. These controlled conditions are closely monitored by the supplier to ensure integrity upon delivery.
Q: What is the benefit of using Luliconazole Powder API from this manufacturer in India?
A: Choosing this source provides assurance of stringent quality standards, customizable packaging, regulatory complianceincluding DMF supportand documented safety, making it an ideal option for consistent and reliable pharmaceutical manufacturing processes.
Q: How does the manufacturer ensure regulatory and documentation compliance for global markets?
A: The supplier provides comprehensive regulatory documentation, including Certificates of Analysis and DMF availability on request, streamlining importation and registration processes for international clients. Adherence to USP/EP, pharmacopeial, and ICH guidelines further supports compliance.