Rokitamycin API is a 16-membered macrolide antibiotic belonging to the macrolide class of antibacterial agents. It is a semisynthetic derivative of leucomycin A5 and is associated with the macrolide antibiotics produced from Streptomyces kitasatoensis. Rokitamycin is also known by the names Ricamycin and TMS-19-Q.
Rokitamycin has been used as an antibacterial pharmaceutical ingredient, particularly against susceptible Gram-positive and selected respiratory pathogens. Like other macrolides, its antibacterial action is associated with interaction with the bacterial ribosome and inhibition of bacterial protein synthesis.
Rokitamycin has the CAS number 74014-51-0, molecular formula C42H69NO15, and molecular weight 827.99 g/mol according to the Japanese Pharmacopoeia and PubChem. PubChem currently reports the molecular weight as approximately 828.0 g/mol.
The API is described in the Japanese Pharmacopoeia as a white to yellowish-white powder. It is very soluble in methanol and chloroform, freely soluble in ethanol and acetonitrile, and practically insoluble in water.
Rokitamycin is a complex macrolide structure containing a 16-membered lactone ring and deoxy-sugar components with dimethylamino functionality. Its molecular structure contains multiple stereocenters and oxygen-containing functional groups characteristic of macrolide antibiotics.
The compound is structurally related to leucomycin derivatives and was developed through chemical modification of the macrolide framework. Its defined chemical identity and stereochemical structure make appropriate chromatographic and spectroscopic identification important for API quality control.
Rokitamycin has been used as a macrolide antibacterial agent for susceptible bacterial infections. Its pharmacological action is associated with inhibition of bacterial protein synthesis through interaction with the bacterial ribosomal system.
The compound has historically been used particularly in antibacterial treatment involving respiratory and other susceptible infections. Its pharmaceutical application should be evaluated according to the regulatory status and approved indications applicable in the intended market.
Rokitamycin requires comprehensive quality evaluation because it is a structurally complex macrolide antibiotic.
Analytical testing can include UV-visible spectroscopy, FTIR, NMR, HPLC/LC testing for related substances, water determination, residue on ignition, heavy-metal testing and microbiological potency assay.
The historical Japanese Pharmacopoeia monograph used UV-visible and infrared spectroscopy for identification and a cylinder-plate microbiological assay for potency. The assay used Kocuria rhizophila ATCC 9341 in the later JP monograph.
Rokitamycin API manufacturing requires controlled synthesis, purification and quality testing to maintain consistent potency and impurity profiles. Because the molecule is a complex macrolide antibiotic, control of degradation products and related macrolide substances is particularly important.
A quality-focused manufacturing process can be supported by validated chromatographic methods, microbiological potency testing, identity testing and batch-specific analytical documentation.
Rokitamycin should be packed in tight, well-closed pharmaceutical containers suitable for protecting the API from environmental exposure.
The historical Japanese Pharmacopoeia monograph specifies tight containers for Rokitamycin.
Storage should follow the validated stability data for the particular API batch and packaging system.
Typical documentation for Rokitamycin API may include:
Rokitamycin is a well-characterized macrolide antibiotic with an established chemical identity, historical pharmacopoeial monograph and defined microbiological potency-testing methodology. Its complex molecular structure makes appropriate control of identity, potency, related substances, water and inorganic residues important for pharmaceutical API quality.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.2% |
| Total Impurities | NMT 3.0% |
| Water Content | NMT 3.0% |