Description

Citric Acid Clarithromycin is a pharmaceutical-grade intermediate, specifically the citrate salt form of the broad-spectrum macrolide antibiotic clarithromycin. This compound is critical for ensuring the stability, bioavailability, and precise formulation of final drug products. It is primarily required by manufacturers in the pharmaceutical industry for the production of solid and liquid dosage forms, including tablets and suspensions.

Application

• Pharmaceutical Active Ingredient (API) Intermediate: Key starting material for the synthesis and purification of clarithromycin.
• Antibiotic Formulation: Used in the manufacture of finished dosage forms to treat respiratory tract, skin, and soft tissue infections.
• Drug Salt Formation: The citrate salt improves the compound's physical properties, such as crystallinity and solubility, for better processing.
• Veterinary Medicine Production: Employed in creating antibiotic treatments for animals.
• Research & Development: Serves as a high-purity reference standard in analytical laboratories and for new drug development studies.

Basic Information

Product Name	Citric Acid Clarithromycin
CAS No.	509074-22-0
Molecular Formula	C44H79NO20
Molecular Weight	942.10 g/mol
Synonyms	Clarithromycin citrate; Clarithromycin monohydrate citrate; 6-O-Methylerythromycin A citrate; Biaxin citrate; Klaricid citrate; (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-12,13-dihydroxy-7-methoxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione citrate; A-56268 citrate; TE-031 citrate
EINECS	Contact for details

Quality Control

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

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 6.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines
Specific Rotation	-94° to -100° (c=1 in CHCl3)

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