Description

Roxithromycin Lactobionate is a water-soluble salt form of the semi-synthetic macrolide antibiotic, roxithromycin. This compound is critical for the formulation of stable, injectable pharmaceutical preparations, ensuring high bioavailability and therapeutic efficacy. It is primarily required by manufacturers in the pharmaceutical and biotechnology sectors for the production of advanced antibiotic treatments targeting respiratory, skin, and soft tissue infections.

Application

• Injectable Pharmaceutical Formulations: As the active pharmaceutical ingredient (API) in sterile injectable solutions for hospital and clinical use.
• Lyophilized (Freeze-Dried) Powder Products: For the production of stable, reconstitutable antibiotic powders.
• Veterinary Medicine: Used in the development of antibiotic treatments for bacterial infections in animals.
• Research & Development: Serves as a key reference standard and intermediate in pharmacological and microbiological research.
• High-Purity API Synthesis: As a starting material or intermediate for the synthesis of other specialized macrolide derivatives.

Basic Information

Product Name	Roxithromycin Lactobionate
CAS No.	305831-46-3
Molecular Formula	C41H76N2O15 • C12H22O12
Molecular Weight	Approx. 1055.2 g/mol
Synonyms	Roxithromycin Monolactobionate; Erythromycin 9-[O-[(2-Methoxyethoxy)methyl]oxime] Lactobionate; RU 965 Lactobionate; (9E)-9-{O-[(2-Methoxyethoxy)methyl]oxime}erythromycin Lactobionate; Roxithromycin Lactobiomate; Roxithromycin Lactobionic Acid Salt; Roxithromycin (Lactobionate); Roxithromycin, lactobionate salt
EINECS	Contact for details

Quality Control

Our Roxithromycin Lactobionate is manufactured and tested under strict quality management systems. We ensure compliance with current industry standards for pharmaceutical intermediates and active ingredients. A comprehensive Certificate of Analysis (COA), detailing purity, identity, and impurity profiles as determined by validated methods (e.g., HPLC), is provided with each batch to guarantee supply reliability and product consistency for your critical formulations.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0 %
pH (in solution)	5.0 - 7.0
Related Substances (HPLC)	Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Bacterial Endotoxins	< 0.25 EU/mg (for injectable grade)

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