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Glibenclamide API Powder
- Product Description
Glibenclamide API Powder: Premium Quality for Reliable Diabetes Management
Welcome to Guangzhou Jben Biotechnology Co., Ltd., your trusted manufacturer and supplier of high-quality Glibenclamide API Powder. Our advanced R&D capabilities and strict quality control processes ensure that we deliver superior product to meet the growing demands of the pharmaceutical industry. With our GMP-certified facilities and extensive inventory, we're committed to providing you with reliable, compliant, and cost-effective solutions for your antidiabetic medication needs.
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What is Glibenclamide API Powder?
Our product, also known as glyburide, is a potent sulfonylurea-class antidiabetic medication used in the treatment of type 2 diabetes mellitus. As an active pharmaceutical ingredient (API), it serves as the core component in the formulation of oral hypoglycemic drugs.
Glibenclamide API Powder Specification
| Parameter | Specification |
|---|---|
| Appearance | White or almost white crystalline powder |
| Assay | 98.0% - 102.0% (on dried basis) |
| Melting Point | 169°C - 174°C |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.2% |
| Heavy Metals | ≤ 10 ppm |
| Particle Size | 100% through 80 mesh |
What is Glibenclamide API Powder used for?
Glibenclamide API Powder is primarily used in the pharmaceutical industry for:
- Manufacturing oral antidiabetic medications
- Formulating generic versions of branded glyburide products
- Developing combination therapies for comprehensive diabetes management
- Research and development of new diabetes treatments
Dosage and Usage
The typical dosage range for Glibenclamide in finished pharmaceutical products is 1.25 mg to 20 mg per day, usually divided into multiple doses. However, as an API supplier, we recommend following the specific formulation guidelines provided by regulatory authorities and your product development team.
Why Choose Us?
- Stringent Quality Control: Our product undergoes rigorous testing to ensure consistent purity and potency.
- Regulatory Compliance: We adhere to international pharmacopoeial standards and provide comprehensive documentation support.
- Flexible Supply Chain: With our large inventory and efficient logistics, we can meet your order requirements promptly.
- Technical Expertise: Our team of experts offers valuable insights for your formulation and regulatory needs.
- Competitive Pricing: We offer attractive bulk pricing and long-term contract options to optimize your costs.
Security Certification
Our Glibenclamide API Powder production follows strict GMP guidelines and has obtained the following certifications:
- ISO 9001:2015 Quality Management System
- WHO-GMP Certification
- U.S. FDA Drug Master File (DMF) Registration
- European CEP Certification
Packaging and Delivery
- Standard Packaging: 25 kg fiber drums with double-layer PE bags
- Custom packaging available upon request
- Air-tight and light-resistant containers to ensure product stability
- Global shipping with temperature-controlled options for sensitive markets
FAQs
- Q: What is the shelf life of your product?
A: Our product has a shelf life of 36 months when stored properly in original packaging at controlled room temperature. - Q: Can you provide stability data for your Glibenclamide API?
A: Yes, we offer comprehensive stability data, including long-term and accelerated studies, to support your regulatory filings. - Q: Do you offer samples of product?
A: We provide samples for evaluation purposes to qualified buyers. Please contact our sales team for more information. - Q: What is your minimum order quantity (MOQ) for product?
A: Our standard MOQ is 25 kg, but we can discuss smaller quantities for initial orders or R&D purposes. - Q: How do you ensure the consistency of your product across batches?
A: We employ robust process controls and conduct thorough batch-to-batch analysis to guarantee consistent quality. - Q: Can you assist with regulatory documentation for international markets?
A: Absolutely. Our regulatory affairs team can provide necessary documentation, including DMFs and CEPs, to support your global registrations.
Contact Us
Ready to elevate your diabetes treatment portfolio with our premium Glibenclamide API Powder? Contact Guangzhou Jben Biotechnology Co., Ltd. today for inquiries, quotes, or technical support.
Email: xxx817488@gmail.com
Trust in our expertise to deliver high-quality product for your pharmaceutical needs. Let's partner in advancing diabetes care worldwide.
