Description

Solithromycin CAS NO 760981-83-7 is a novel, third-generation fluoroketolide antibiotic developed for the treatment of community-acquired bacterial pneumonia (CABP). This advanced macrolide compound offers a potent mechanism of action against multi-drug resistant respiratory pathogens, including macrolide-resistant strains. It is a critical active pharmaceutical ingredient (API) for pharmaceutical R&D and manufacturing, targeting unmet medical needs in anti-infective therapy.

Application

• Primary Active Pharmaceutical Ingredient (API) in the formulation of antibacterial drugs.
• Research and development of novel antibiotic therapies for respiratory tract infections.
• Clinical studies targeting community-acquired bacterial pneumonia (CABP).
• Development of treatments for other bacterial infections where macrolide antibiotics are indicated.
• Reference standard for analytical and quality control laboratories.
• Biochemical research into bacterial protein synthesis and antibiotic resistance mechanisms.

Basic Information

Product Name	Solithromycin
CAS No.	760981-83-7
Molecular Formula	C₄₃H₆₅FN₆O₁₀
Molecular Weight	845.01 g/mol
Synonyms	OP-1068; Solithera; CEM-101; (3R,4S,5R,8R,10R,11R,12S,13R)-11-[(2S,3R,4S,6R)-4-Dimethylamino-3-hydroxy-6-methyloxan-2-yl]oxy-3-ethyl-4,5,10,13-tetrahydroxy-12-{[(2R,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}-6-{[(1R,2R)-1-hydroxy-1-[(4-{4-[4-(trifluoromethyl)phenyl]piperazin-1-yl}phenyl)methyl]propan-2-yl]oxy}-3,4,5,6,7,8,10,11,12,13-decahydro-1H-cyclopenta[a]cycloundecen-1-one
EINECS	Contact for details

Quality Control

Our Solithromycin is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity, identification by IR and NMR, and stringent control of related substances and residual solvents. A Certificate of Analysis (COA) is provided with each shipment, ensuring compliance with ICH guidelines and relevant pharmaceutical standards for active ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.