Roxithromycin
Also known as: Rulide, Roxid, Surlid, Roxo, Biaxsig
CAS Number: 80214-83-1
Macrolide Antibacterial
Pharmacopeia Standards
Mechanism of Action
Roxithromycin binds reversibly to the 23S rRNA of the bacterial 50S ribosomal subunit, blocking the peptide exit tunnel and arresting translocation of peptidyl-tRNA. Protein synthesis stalls, producing a bacteriostatic effect against most susceptible Gram-positive cocci and atypical respiratory pathogens. The 9-[O-(2-methoxyethoxy)methyl]oxime side chain confers markedly greater acid stability than erythromycin base.
Technical Specifications
| Generic / INN Name | Roxithromycin |
| CAS Registry Number | 80214-83-1 |
| Molecular Formula | C41H76N2O15 |
| Molecular Weight | 837.05 g/mol g/mol |
| Typical Purity | 98.0-102.0% on the anhydrous basis (EP/BP); single unspecified impurity NMT 0.5%, total impurities NMT 3.0% |
| Storage Conditions | Store in tightly closed HDPE drums with double LDPE liner, protected from light and moisture, below 25 degrees C |
| Shelf Life | 48 months from date of manufacture when stored per label conditions |
| Category | Macrolides |
Specifications are indicative and intended for sourcing reference only. Always confirm against the supplier's Certificate of Analysis and the applicable pharmacopeial monograph before issuing a purchase specification.
Typical Applications
Oral solid dosage forms (film-coated tablets, dispersible paediatric tablets, dry syrup for reconstitution) and fixed-dose combinations with ambroxol or bromhexine that are common in Indian and Southeast Asian respiratory portfolios.
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