Description

Clarithromycin Lactobionate is a water-soluble salt form of the broad-spectrum macrolide antibiotic clarithromycin. This formulation is critical for enhancing the bioavailability and stability of the active pharmaceutical ingredient in parenteral and ophthalmic dosage forms. It is primarily utilized by pharmaceutical manufacturers and research institutions in the development and production of injectable and topical antibiotic solutions.

Application

• Injectable Antibiotic Formulations: Primary use in the manufacture of sterile intravenous (IV) and intramuscular (IM) solutions for the treatment of severe bacterial infections.
• Ophthalmic Preparations: Used in the formulation of eye drops and ointments for treating bacterial conjunctivitis and other ocular infections.
• Veterinary Pharmaceuticals: Incorporated into injectable products for bacterial infections in livestock and companion animals.
• Pharmaceutical Intermediates: Serves as a key intermediate in the synthesis of other clarithromycin-based drug products.
• Research & Development: Employed in preclinical and clinical studies for pharmacokinetic and efficacy testing of new antibiotic therapies.
• Hospital Compounding: Used in pharmacy compounding for preparing patient-specific parenteral nutrition or antibiotic admixtures where standard formulations are unsuitable.

Basic Information

Product Name	Clarithromycin Lactobionate
CAS No.	135326-55-5
Molecular Formula	C41H75NO19
Molecular Weight	886.04 g/mol
Synonyms	6-O-Methylerythromycin A Lactobionate; Clarithromycin Monolactobionate; Biaxin Lactobionate; Klaricid Lactobionate; (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione Lactobionate
EINECS	Contact for details

Quality Control

Our Clarithromycin Lactobionate is manufactured under strict quality management systems. It undergoes rigorous analytical testing to ensure compliance with pharmaceutical-grade standards, including identity, purity, and impurity profile verification. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results from HPLC, IR, and other relevant pharmacopeial tests.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
pH (10% solution)	5.0 - 7.0
Clarity of Solution	Clear
Related Substances (HPLC)	Total impurities ≤ 2.0%
Residual Solvents (GC)	Meets ICH guidelines
Bacterial Endotoxins	< 0.25 EU/mg
Sterility (for sterile grade)	Sterile

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