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Product Line: Pharmaceutical Chemicals

Clarithromycin

CAS 81103-11-9

Molecular structure of Clarithromycin

CAS · 81103-11-9

01

Product Overview

Clarithromycin is a high-purity a-api supplied for industrial and specialty chemical applications. Contact our team for specifications, packaging options and lead times.

02

Product Specifications

Appearance: White to off-white, crystalline powder
Infrared absorption: Corresponds to RS
Liquid phase identification: Retention time of the main peak of the test solution should match the reference solution
Optical rotation: -94° ~ -102°
Crystallinity: Meets the requirement
pH: 8.0 ~ 10.0
Water: 2.0% max
Related substances (HPLC): Impurity I: 1.0% max
Impurity A: 1.0% max
Impurity J: 1.0% max
Impurity L: 1.0% max
Impurity B: 1.0% max
Impurity M: 1.0% max
Impurity C: 1.0% max
Impurity D: 1.0% max
Impurity N: 1.0% max
Related compound A: 1.0% max
Impurity F: 1.0% max
Impurity P: 1.0% max
Impurity O: 1.0% max
Impurity K: 1.0% max
Impurity G: 1.0% max
Impurity H: 1.0% max
Any other individual impurity: 1.0% max
Impurities exceed 0.4%: 4 max
Total impurity: 3.5% max
Residue on ignition: 0.2% max
Assay (HPLC, on anhydrous basis): 96.0 ~ 102.0%
Additional test – Residual solvent (GC): Dichloromethane: 600 ppm max
Ethanol: 5000 ppm max
Methanol: 3000 ppm max
Acetic acid: 5000 ppm max
03

Applications

 

 

1.1 Respiratory Tract Infections

Clarithromycin is commonly used for treating upper and lower respiratory tract infections. These include:

Pharyngitis and tonsillitis (primarily caused by Streptococcus pyogenes)

Acute bacterial sinusitis

Acute exacerbations of chronic bronchitis (AECB)

Community-acquired pneumonia (CAP)

Its efficacy against common respiratory pathogens like Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis makes it an important drug in outpatient care settings.

1.2 Skin and Soft Tissue Infections

Clarithromycin treats mild to moderate skin and soft tissue infections, such as:

Cellulitis

Impetigo

Erysipelas

It is effective particularly against Staphylococcus aureus and Streptococcus pyogenes, especially in patients allergic to penicillin.

1.3 Helicobacter pylori Eradication

One of the major advances with clarithromycin was its use in triple therapy for Helicobacter pylori infection, which is linked to peptic ulcers and gastric cancer. Clarithromycin, in combination with a proton pump inhibitor (e.g., omeprazole) and another antibiotic (e.g., amoxicillin or metronidazole), is standard for eradicating H. pylori.

1.4 Mycobacterial Infections

Clarithromycin is highly effective in the treatment and prophylaxis of:

Disseminated Mycobacterium avium complex (MAC) infections in HIV/AIDS patients

Pulmonary infections caused by Mycobacterium kansasii or Mycobacterium abscessus

It is a cornerstone in nontuberculous mycobacterial (NTM) therapy due to its intracellular activity and good tissue penetration.

1.5 Otitis Media

In children and adults, clarithromycin is used to treat:

Acute otitis media (AOM)

Chronic suppurative otitis media, especially where resistance to other antibiotics or allergies limit treatment choices.

1.6 Dental Infections

Clarithromycin may be prescribed for dental abscesses and periodontitis due to its penetration into gingival tissue and bone.

1.7 Off-Label Uses

While not officially approved, clarithromycin has been explored in:

Treatment of rosacea, due to its anti-inflammatory properties

Rheumatoid arthritis and chronic sinusitis, where bacterial persistence and inflammation coexist

04

Benefits

 

 

2.1 Broad Spectrum of Activity

Clarithromycin is active against both Gram-positive and Gram-negative bacteria, including atypical pathogens like:

Mycoplasma pneumoniae

Chlamydophila pneumoniae

Legionella pneumophila

This makes it highly versatile for empirical treatment.

2.2 Good Oral Bioavailability

Clarithromycin has high oral bioavailability (~55%) and is available in tablets, extended-release formulations, and oral suspensions. This allows flexible dosing and convenient outpatient use.

2.3 Improved Acid Stability

Unlike erythromycin, clarithromycin is stable in acidic environments, leading to:

Reduced gastrointestinal side effects

Better absorption

Improved patient compliance

2.4 Anti-Inflammatory and Immunomodulatory Effects

Studies have demonstrated that clarithromycin exhibits:

Inhibition of cytokine production

Reduction in neutrophil recruitment

Decreased mucus secretion

These effects are beneficial in chronic respiratory diseases like COPD and diffuse panbronchiolitis, where inflammation plays a central role.

2.5 Tissue Penetration and Intracellular Activity

Clarithromycin achieves high concentrations in tissues and cells, making it effective against intracellular pathogens such as Chlamydia and Mycobacteria. This also supports its efficacy in deep-seated infections.

2.6 Dual Action in H. pylori Therapy

In H. pylori eradication, clarithromycin not only kills the bacteria but also reduces inflammation in the gastric mucosa, promoting ulcer healing.

2.7 Reduced Frequency of Dosing

The extended-release version of clarithromycin allows once-daily dosing, improving adherence, especially in long-term treatments like MAC prophylaxis or H. pylori therapy.

05

Conclusion

Clarithromycin (CAS 81103-11-9) is a valuable and versatile macrolide antibiotic used globally for:

Respiratory tract infections

Skin and soft tissue infections

H. pylori eradication

Mycobacterial diseases

Otitis media and dental infections

Its benefits include broad-spectrum activity, good tissue penetration, intracellular efficacy, and anti-inflammatory properties. With both oral and extended-release formulations, clarithromycin remains an essential antibiotic in modern clinical practice.

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