Glibenclamide API Powder
Glibenclamide API Powder: High-Quality Antidiabetic Ingredient
Guangzhou Jianbei Biotechnology Co., Ltd. is a leading manufacturer and supplier of Glibenclamide API Powder. Our company excels in producing this essential antidiabetic ingredient, leveraging our strong technical R&D capabilities and professional talent pool. Guangzhou Jianbei's product stands out for its consistent quality, regulatory compliance, and competitive pricing, making us a preferred choice for pharmaceutical manufacturers worldwide.
Product Introduction
Glibenclamide API Powder, also known as glyburide, is a crucial active pharmaceutical ingredient used in the production of oral antidiabetic medications. This sulfonylurea-class compound effectively lowers blood glucose levels by stimulating insulin release from pancreatic beta cells. Our high-purity product meets stringent pharmacopeial standards, ensuring optimal efficacy and safety in finished formulations.
Specifications:
| 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 | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
Uses and Applications
The product is primarily used in the manufacturing of:
- Oral antidiabetic tablets for type 2 diabetes management
- Combination therapies with other glucose-lowering agents
- Extended-release formulations for improved patient compliance
Dosage and Usage
The typical dosage range for Glibenclamide in finished formulations is 1.25 mg to 20 mg daily, divided into multiple doses. Precise dosing should be determined by healthcare professionals based on individual patient needs and glycemic control.
Quality Standards and Certifications
Our Glibenclamide API Powder adheres to the highest quality standards, including:
- USP (United States Pharmacopeia)
- EP (European Pharmacopoeia)
- BP (British Pharmacopoeia)
- JP (Japanese Pharmacopoeia)
Guangzhou Jianbei Biotechnology Co., Ltd. operates under strict GMP guidelines, ensuring consistent product quality. We maintain ISO 9001 certification and regularly undergo audits by regulatory bodies, demonstrating our commitment to excellence in API manufacturing.
Packaging
We offer flexible packaging options to meet diverse client needs:
- 5 kg aluminum foil bags
- 25 kg fiber drums with double-layer PE liners
- Custom packaging available upon request
Why Choose Us
Guangzhou Jianbei Biotechnology Co., Ltd. stands out as your ideal product supplier for several reasons:
- Consistent Quality: Our advanced GMP-compliant facilities and stringent quality control measures ensure batch-to-batch consistency.
- Competitive Pricing: We offer attractive pricing without compromising on quality, supporting your cost-effective production goals.
- Regulatory Support: Our experienced team provides comprehensive documentation and regulatory assistance for smooth market entry.
- Reliable Supply Chain: With ample inventory and efficient logistics, we guarantee timely delivery to meet your production schedules.
- Technical Expertise: Our R&D team offers valuable insights for product development and optimization.
FAQ
- What is the shelf life of your product?
Our product typically has a shelf life of 3 years when stored properly in original packaging. - Do you provide stability data for Glibenclamide API?
Yes, we offer comprehensive stability data to support your formulation development and regulatory filings. - Can you supply product in small quantities for R&D purposes?
Certainly! We offer flexible quantity options to accommodate your research and development needs. - What markets do you currently supply product to?
We supply to global markets, including regulated markets in North America, Europe, and emerging economies in Asia and Africa. - How quickly can you fulfill orders for product?
Standard lead times are 4-6 weeks, but we can accommodate rush orders based on our current inventory levels.Contact Us
For inquiries or to request a quote for our Glibenclamide API Powder, please contact our sales team at h33727868@gmail.com. We're ready to assist you with product information, documentation, and support for your regulatory submissions.
