Azaerythromycin Powder

Azaerythromycin Powder for Pharmaceutical Manufacturing – Premium Quality API with Superior Acid Stability

Shaanxi Hongda Phytochemistry Co., Ltd. has a remarkable reputation for producing high-purity Azaerythromycin Powder that fulfils strict international pharmaceutical requirements. After 20 years in natural compound extraction and API synthesis, we offer pharmaceutical companies a consistent, 99% pure product to solve formulation issues. Our sophisticated 20,000 square meter plant and 100,000-level purification workshops assure excellent product consistency. Our SGS-standardized laboratory with more than 20 professor-level R&D experts provides complete quality verification. Each batch is tested for purity, residual solvents, heavy metals and microbes in accordance with USP, EP and BP standards. With a partnership with Shaanxi Hongda, you will get cGMP certified, FSSC22000 certified manufacturing capabilities that are strengthened by HALAL, KOSHER, ISO9001 and ISO22000 Certifications to provide you pharmaceutical quality materials and speed time-to-market.

Introduction to the Product

The product is the key Active Pharmaceutical Ingredient for the azalide family of macrolide antibiotics. It is a white crystalline powder and includes 15-membered ring. The Erythromycin A lactone ring is modified by the introduction of a nitrogen atom. This structural change provides excellent acid stability and prolonged pharmacokinetic qualities and is suitable for formulation of wide range antibiotics for treatment of respiratory, urogenital and dermatological illnesses. The powder has a better tissue penetration and longer half-life than conventional macrolides, allowing for streamlined dose regimens that improve patient compliance in therapeutic uses.

Third Party Test Report

Independent Testing: We send our goods out for extensive third-party testing at an authorised lab such as SGS, Eurofins, etc. to verify quality beyond our own internal controls.

Pesticide Residue Analysis: Multi-residue screening to ensure no agricultural pollutants, assuring pharmaceutical-grade purity for regulated markets such as the EU and North America.

Heavy Metal Profiling: ICP-MS analysis shows that lead, arsenic, mercury, and cadmium levels are considerably within ICH Q3D standards, providing a safe end-user experience and satisfying export criteria.

Microbiological Safety: Total plate count, yeast, mould and pathogen testing confirms microbiological loads are within tight pharmaceutical criteria for oral dose manufacture.

Product Specification

Azaerythromycin Powder Advantages

Improved acid stability: The 15-membered ring structure with nitrogen modification does not degrade in the stomach, removing the requirement for enteric coating, which simplifies the manufacturing process and reduces the cost of manufacture.

Enhanced Bioavailability: Lipophilicity allows for fast access to cells and excellent tissue penetration, resulting in therapeutic concentrations at the sites of infection, while minimising systemic exposure.

Extended Half Life: The extended pharmacokinetic profile allows for once-daily dosage regimens, which greatly promote patient compliance compared to multi-dosing of standard macrolides.

Low Hygroscopicity: Low moisture uptake during handling and storage preserves powder flowability and avoids crystalline form alterations that can influence dissolving properties.

Complete Quality Assurance: All manufacturing batches are monitored for HPLC purity profile, particle size distribution, Karl Fischer water content and GC residual solvent screening to maintain consistent pharmaceutical performance.

Uses of Azaerythromycin Powder

Oral Solid Dosage Manufacturing: This powder is the preferred API for immediate-release tablets and capsule formulations for community acquired pneumonia and acute bacterial sinusitis when the acid stability means no complicated coating is required.

Paediatric Suspension Development: The reconstituted aqueous system has a unique solubility profile and stability of the powder, making it appropriate for the development of pleasant oral suspensions with longer shelf-life, which allows for simple once-daily dosing in paediatric patients.

High-Dose Clinical Treatments: Pharmaceutical producers use this powder to make single-dose treatment regimens for sexually transmitted diseases, where its superior bioavailability assures bactericidal tissue concentrations essential for public health compliance.

Why Choose Us

Manufacturing Excellence: 3,000 tonnes per year manufacturing capability, with more than 150 qualified experts to enable sustainable supply continuity for your pharmaceutical business.

Quality Infrastructure SGS-standardized labs with HPLC, GC, UV-Vis and ICP-MS technology provide analytical capabilities comparable to international reference laboratories.

Certification Portfolio: We are proud to have cGMP, FSSC22000, ISO9001, ISO22000, BRC, HALAL and KOSHER certifications to show our dedication to satisfy the most severe worldwide pharmaceutical standards.

Traceability Systems: Complete supply chain visibility and regulatory compliance are ensured by detailed batch documentation from raw material procurement to final Packaging.

Technical Excellence: Our R&D group is composed of professor-level scientists that collaborate with our university partners to continually improve our manufacturing methods to ensure we provide technically superior goods based on profound scientific understanding.

Production Process

Step 1 – Raw Material Selection: Qualified Erythromycin A undergoes rigorous identity testing and purity verification. Result: Only materials meeting pharmaceutical monograph specifications advance to synthesis.

Step 2 – Ring Modification Synthesis: Controlled nitrogen insertion reactions modify the lactone ring structure under strict temperature and pH parameters. Result: Formation of the stable 15-membered azalide ring with minimized impurity generation.

Step 3 – Purification and Crystallisation: The target compounds are separated from byproducts of the reaction by a multi-stage solvent extraction and controlled crystallisation. Uniform particle properties of high purity crystalline powder.

Step 4 – Micronization and Drying: Precision milling and controlled vacuum drying to meet desired particle size distribution. Enhanced dissolving by optimised powder and steady moisture content.

Step 5 – Quality Testing and Packaging: The product undergoes extensive analytical testing to verify that it meets all specifications. Only then is it packaged aseptically into double layer PE bags and fibre drums. Result: Pharma quality Azaerythromycin Powder for safe shipment.

OEM/ODM Support

Custom Specification Development: Our R&D team will work with you to produce product specifications including optimisation of particle size and alternate salt forms to meet your particular formulation needs.

Formulation Technical Support: We provide complete dissolution testing data, compatibility studies with common excipients and stability assistance to help you expedite your product development schedule.

Flexible Packaging Solutions We possess the expertise to handle a wide variety of packaging requirements, from large scale manufacture in bulk barrels to smaller numbers for clinical trial batches, using approved containment methods.

Regulatory Document Assistance: Extensive help in Drug Master File (DMF) development, Certificate of Suitability (CEP) support, and analytical technique transfer to enable hassle-free regulatory filings.

FAQ

Q: How does your products maintain stability during long-distance shipping?

A: Our double-layer PE packaging within fiber drums protects against moisture ingress and light exposure, while we provide validated stability data supporting ambient temperature shipping for up to 30 days.

Q: Can you provide samples for formulation development testing?

A: Yes, we offer 100g evaluation samples packaged in aluminum foil bags with complete CoA documentation to support your initial compatibility and dissolution studies.

Q: What differentiation testing confirms this is Azaerythromycin versus Erythromycin A?

A: HPLC retention time comparison, mass spectrometry molecular weight confirmation, and specific optical rotation measurements definitively distinguish the 15-membered azalide structure from the 14-membered erythromycin precursor.

Q: Do you support annual supply agreements with price protection?

A: Absolutely. We offer multi-year framework agreements with volume-based pricing tiers and raw material cost adjustment clauses that provide budget predictability for your procurement planning.

Q: What is your typical lead time from purchase order to shipment?

A: For stock specifications, we ship within 3-7 working days. Custom specifications require 15-20 working days depending on testing requirements and order volume.

Contact Us

Ready to secure a reliable supply of pharmaceutical-grade Azaerythromycin Powder for your manufacturing operations? Contact Us today at duke@hongdaherb.com  to request product samples, CoA documentation, or pricing information.