Clarithromycin Powder

High-Quality Clarithromycin Powder - Trusted Manufacturer & Supplier

Shaanxi Hongda Phytochemistry Co., Ltd. is a leading manufacturer and supplier of pharmaceutical grade Clarithromycin Powder to the pharmaceutical industry all over the world with the highest quality and reliability. We have produced this significant semi-synthetic macrolide antibiotic API with verified 99% purity by HPLC and two decades of production experience since 2001. It is created in our state-of-the-art 20,000 square metre manufacturing facility with 100,000 level clean rooms and innovative extraction technology to ensure that each batch of product meets strict international pharmacopoeial regulations such as USP, EP and BP. What makes us different is the full quality control system by over 20 professors level professionals, third party verification by SGS and Eurofins and various Certifications such as cGMP, FSSC22000, ISO9001, HALAL and KOSHER. By partnering with Hongda, you gain access to reliable supply chains with 3,000 tonne annual capacity, factory-direct pricing, full documentation support for regulatory compliance, and responsive technical service to help you speed up your formulation development and market entry.

Product Introduction

Clarithromycin Bulk is a pharmaceutical breakthrough for a excessive purity lively pharmaceutical ingredient inside the macrolide antibiotic own family. It is chemically 6-o-methylerythromycin, cas range 81103-eleven-9, and is a white to off white crystalline powder this is more acid solid than erythromycin. The strategic methylation at c-6 function substantially complements oral bioavailability with little gastrointestinal adverse occasions. It has a molecular weight of 747.95 g/mol and a chemical components of c38h69no13 . It has appropriate lipophilicity which helps better penetration into tissues specifically respiration tissues and macrophages. Our product is a high grade raw cloth for the manufacture of numerous antibiotic formulations for breathing infections and for h. Pylori eradication therapy. It has a steady 99% purity and conforms to all major pharmacopoeial standards.

Clarithromycin Powder Specification

Our clarithromycin Active Pharmaceutical Ingredient meets international pharmaceutical standards:

Third-Party Test Report

Independent Testing for Quality Assurance: Shaanxi Hongda partners with across the world recognized third-birthday party testing laboratories like as sgs and eurofins to conduct rigorous analytical verifications outdoor of our personal exceptional control systems.

Pesticide Residue Analysis : Multi-residue screening with the aid of GC-MS/msMS and LC-MS/MS technologies verify compliance with european and FDA limits delivering pharmaceutical grade purity for safe human intake.

Heavy Metal Testing: ICP-MS analysis confirms that lead, arsenic, cadmium and mercury are far below the limits defined in ICH Q3D guidelines, ensuring patient safety and compliance with regulatory standards.

Microbiological Testing: Confirmed to USP <61> and <62> for total viable aerobic count, yeast and mould counts and absence of pathogens including E. coli, Salmonella and Staphylococcus aureus.

Residual Solvent Testing: Gas chromatography testing confirms that the residual solvents used in the production process are within the permitted limits for ICH Q3C Class 2 and Class 3 solvents, ensuring product safety.

Clarithromycin Powder Advantages

Enhanced Acid Stability: The methylation alteration at C-6 position gives remarkable stability in acidic stomach conditions, leading in 50% greater bioavailability compared to erythromycin and more predictable therapeutic effects.

Superior Tissue Penetration: High lipophilicity helps top notch distribution into breathing tissues, reaching lung tissue concentrations 10-20 times more than serum tiers, making it specifically effective towards respiration infections.

Increased Half-Life: Serum 1/2-lifestyles of 3-7 hours (extended to 5-9 hours for the energetic metabolite) enables for easy twice-daily dosage, improving affected person compliance and healing success fees.

Broad Antimicrobial Spectrum: Effective against a wide range of Gram-positive bacteria, atypical pathogens including Mycoplasma and Chlamydia, and Helicobacter pylori, providing versatile therapeutic applications across multiple infection types.

Fewer gastrointestinal side effects: The structural change greatly reduces the motility-stimulating consequences that are usually related to erythromycin, ensuing in higher affected person tolerance and a lower rate of remedy termination.

Enhanced Manufacturing Characteristics: Our micronised product gives a uniform particle size distribution and glide traits, ensuing in uniform content in strong dosage forms and simplicity of formula improvement.

Clarithromycin Powder Application

Respiratory Tract Infection Formulations: The powder is the energetic element within the formula of pills and capsules for the treatment of community-obtained pneumonia, acute bacterial exacerbations of persistent bronchitis and acute maxillary sinutitis where penetration into tissues is essential to efficacy.

Helicobacter Pylori Eradication Therapies: It is an important component of triple and quadruple therapy regimens. It is used in combination with proton pump inhibitors and other antibiotics to provide more than 90% eradication in the management of peptic ulcer disease.

Skin & Soft Tissue Infection Products: Developed oral dosage forms for the treatment of simple skin infections caused by Staphylococcus aureus and Streptococcus pyogenes, providing viable options for outpatient treatment.

Mycobacterial Disease Prevention: Utilized in specific formulations for prophylaxis and treatment of Mycobacterium avium complex (MAC) infections in immunocompromised individuals, particularly those with HIV/AIDS, requiring strict potency consistency.

Pediatric Suspension Preparations: The powder is processed into taste-masked granules for reconstitution, offering age-appropriate formulations for treating otitis media and pharyngitis in children with exact dosing flexibility.

Extended Release Formulation Development: Manufacturers use the substance to formulate extended-release tablets for once-daily administration that increase convenience and compliance for chronic infection care while preserving therapeutic plasma concentrations.

Production Process

Step 1 - Base Compound Fermentation: Manufacturing begins with the fermentation of saccharopolyspora erythraea underneath regulated circumstances to yield erythromycin a as the base compound. The erythromycin base is of excessive purity and manufactured to a regular grade for chemical modification.

Step 2 - Chemical Methylation Reaction: Erythromycin is selectively methylated at the 6-hydroxyl site by methylating agents under carefully controlled temperature and pH conditions . Result: 6-O-methylerythromycin (clarithromycin) was obtained with good conversion efficiency and low by-product formation.

Step 3 - Purification and Crystallisation: The crude product of the reaction is purified by many steps such as solvent extraction, activated carbon treatment and controlled crystallisation in pharmaceutical grade solvents. Result: Crystals of Clarithromycin Powder of high purity according to pharmacopoeial requirements are obtained.

Step 4 - Drying and Micronization: The purified crystals are dried in vacuum at managed temperature and jet milled to obtain the most efficient particle length distribution for pharmaceutical components. Result: pleasant uniform powder with steady particle properties which guarantees extremely good content consistency in dosage paperwork.

Step 5 - Quality Testing and Release: Each production batch is tested extensively including assay determination by HPLC, impurity profiling, residual solvent analysis, heavy metal testing and microbiological examination. Quality packing and release are only approved for batches that fulfil all internal and pharmacopoeial criteria.

Step 6 - Packaging and Storage: The approved powder is filled into double-layer PE bags in fibre drums (25kg net weight) under controlled humidity and kept in temperature-controlled warehouses. Result: Full batch traceability documentation and product stability throughout shelf life.

OEM / ODM Support

Custom Formulation Development: Our professional R&D team of more than 20 scientists will collaborate with you to design optimised clarithromycin formulations such as immediate-release tablets, extended-release systems, capsules and paediatric solutions to suit your target market requirements.

Particle Engineering Services: Customised micronization and particle size optimisation to suit your specific solubility and bioavailability targets to make certain your components meets targeted pharmacokinetic traits and meets regulatory necessities.

Regulatory Documentation Support: Hongda offers full Drug Master Files (DMF), Certificate of Suitability (CEP) and complete analytical documentation packages to support you in your regulatory submission process to FDA, EMA and other health authorities.

Flexible Packaging Solutions: Whether or not you need bulk pharmaceutical packaging in 25kg drums, intermediate volumes in 5kg or 10kg boxes or small improvement samples, we are able to meet your particular packaging necessities with appropriate labelling.

Quality Agreement Customisation: We accomplice together with your fine warranty group to outline permitted specifications, check protocols and trade manage tactics to make sure compliance along with your internal best systems and regulatory necessities.

Private Labeling Options: For certified partners, we provide private labeling services wherein merchandise can be packaged under your emblem identification, assisting your marketplace positioning while preserving our stringent satisfactory standards.

Why Choose Us?

When you choose Shaanxi Hongda Phytochemistry, you’re working with a company that brings 20 years of experience in pharmaceutical manufacturing, innovative technology, and a dedication to quality. We are cGMP- certified facility located in 20,000 m2 area with 100,000-level purification workshops and more than 150 skilful experts to ensure the consistent manufacturing of premium goods with 99% purity. You can also take use of our whole certification portfolio including cGMP, FSSC22000, ISO9001, ISO22000, HALAL, KOSHER and ORGANIC certifications which give access to the global market. We assure rigorous quality verification at every stage of production with our SGS-standardized laboratory equipped with HPLC, GC-MS and atomic absorption spectrophotometers and our team of professor-level scientists. With 3,000 tonnes capacity per year and 3,000 square meters warehousing facilities, we promise consistent supply continuity and fast delivery within 3-7 working days. With our affordable factory direct price, flexible OEM/ODM customisation and devoted technical support staff, we provide you with complete solutions from product creation to commercialisation. When you select Hongda, you’re selecting a depended on companion dedicated on your lengthy-term fulfillment within the pharmaceutical sector.

FAQ

Q: What is the purity level of your product?

A: Our product routinely tests at 99% purity by HPLC and meets/exceeds pharmacopoeial specifications of 96.0%-102.0% on an anhydrous basis.

Q: Which pharmacopoeial criteria does your product meet?

A: Our product is USP (United States Pharmacopoeia), EP (European Pharmacopoeia), BP (British Pharmacopoeia) and JP (Japanese Pharmacopoeia) compliant with full documentation accessible.

Q: How long is your normal lead time for orders?

A: We have a lot of stock and usually send out within 3-7 working days for normal amounts. Custom specs can take 2-3 weeks depending on testing requirements.

Q: Do you have any samples for formulation development?

A: Yes, we have development samples from 20g to 100g in aluminium foil bags with full COA documents for your R&D.

Q: Are you providing regulatory support documentation?

A: Definitely. We can supply you with Drug Master Files (DMF), complete analytical data packages, stability studies, Certificate of Suitability and other regulatory papers to assist you in the approval process.

Q: What certifications does your facility have?

A: Our facility is accredited with cGMP, FSSC22000, ISO9001, ISO22000, BRC, HALAL, KOSHER, ORGANIC (EU and NOP) and has been awarded as a National High-tech Enterprise.

Q: Do you have third party testing?

A: Yes. We frequently do third party verification by SGS and Eurofins for pesticide residues, heavy metals and other key parameters and reports are accessible on request.

Q: What types of packing can you offer?

A: Standard packing is 25 kg net in double-layer PE bags in fibre drums. We also offer customised packaging in 5kg, 10kg or other quantities as required.

Contact Us

Ready to secure a reliable supply of premium-quality Clarithromycin Powder for your pharmaceutical manufacturing needs?

Email: duke@hongdaherb.com