Clarithromycin

Синонимы: Clarithromycin, 6-O-Methylerythromycin A, Klacid, Biaxin, Claripen, C38H69NO13

Clarithromycin is a semi-synthetic macrolide antibiotic derived from erythromycin A through a multistep chemical modification. It belongs to the macrolide class and is widely prescribed for respiratory tract, skin, and soft tissue infections. Since its introduction in the early 1990s, it has become a mainstay in both hospital and community settings, often used in combination regimens for Helicobacter pylori eradication and Mycobacterium avium complex prophylaxis.

Structurally, clarithromycin differs from erythromycin by the methylation of the hydroxyl group at the 6-position of the lactone ring. This modification enhances acid stability, improves oral bioavailability, and reduces gastrointestinal side effects compared to its parent compound. It retains the 14-membered macrolactone ring and the desosamine and cladinose sugars that are characteristic of macrolides. The compound is typically produced via a multi-step synthesis starting from erythromycin A, involving protection, methylation, and deprotection steps.

Commercial clarithromycin is standardized to high purity, generally 98.0% to 102.0% on an anhydrous basis, as determined by HPLC. It is commonly supplied as a white to off-white crystalline powder, practically insoluble in water but soluble in organic solvents such as acetone, methanol, and chloroform. This solubility profile influences formulation strategies, often requiring salt formation or solid dispersion techniques for oral suspensions and immediate-release tablets.

In the global API market, clarithromycin remains a high-demand macrolide, particularly for oral solid dosage forms targeting community-acquired pneumonia, bronchitis, and skin infections. Its stability and broad-spectrum activity against Gram-positive and atypical pathogens make it a reliable choice for formulators developing both generic and branded products.

Function & Mechanism

• Protein synthesis inhibition: Binds to the 50S ribosomal subunit, blocking peptide bond formation and inhibiting bacterial protein synthesis.
• Broad-spectrum activity: Effective against Gram-positive cocci, atypical pathogens (Mycoplasma, Chlamydia, Legionella), and some Gram-negative organisms.
• Acid stability: The 6-O-methyl group protects the molecule from gastric acid degradation, allowing oral administration without enteric coating.
• Post-antibiotic effect: Suppresses bacterial regrowth after exposure, contributing to convenient dosing intervals.
• Immunomodulatory effects: Modulates cytokine production and inflammatory responses, beneficial in chronic respiratory conditions.

Source & Standardization

• Source: Semi-synthetic derivative of erythromycin A
• Manufacturing process: Multi-step chemical synthesis involving protection, methylation, and deprotection
• Standardization: 98.0% – 102.0% (HPLC, anhydrous basis)
• Forms: White to off-white crystalline powder
• Приложения: Oral solid dosage forms (tablets, capsules, suspensions), combination therapy for H. pylori

Quality Specifications (QC Tests)

Bulk Supply & Documentation

• Monthly capacity: 5 MT
• Срок выполнения заказа: 3–5 рабочих дней (товары, имеющиеся в наличии)
• Documentation: COA, MSDS, TDS, stability data, regulatory support
• Packaging: 25 kg fiber drum with double polyethylene liners

Frequently Asked Questions

What is the minimum order quantity (MOQ) for clarithromycin?

Our standard MOQ is 1 kg. For larger quantities, we offer competitive pricing and flexible shipping terms.

What is the delivery time?

For stock items, delivery is 3-5 business days after order confirmation.

Do you provide a Certificate of Analysis (COA) and samples?

Yes, we provide a COA for each batch and can supply samples for qualification purposes. Sample dispatch is typically arranged within 1-2 days.

Contact & Ordering Information

• Company: LyvBio Co., Ltd.
• Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
• Email: info@lyvbio.com
• Phone: +86-29-65816888

send us your specification for a quotation.