Description

Decladinose Roxithromycin (Roxithromycin Impurity B) is a key chemical reference standard and impurity used in the pharmaceutical development and quality control of the macrolide antibiotic, Roxithromycin. This compound is critical for ensuring the purity, safety, and regulatory compliance of the final drug product through accurate analytical profiling. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in API synthesis, method validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Decladinose Roxithromycin in Roxithromycin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities during the manufacturing process.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific degradation impurity under various stress conditions (e.g., heat, humidity, light) to establish product shelf life.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways of Roxithromycin and to develop improved synthetic processes with lower impurity levels.

Basic Information

Product Name	Decladinose Roxithromycin (Roxithromycin Impurity B)
CAS No.	214902-82-6
Molecular Formula	C41H76N2O15
Molecular Weight	837.06 g/mol
Synonyms	Roxithromycin Impurity B; Decladinosylroxithromycin; 3'-N-Desmethyl-3'-N-formylroxithromycin; 9-{O-[(2R,3S,4R,5S,6R)-5-(Dimethylamino)-4-hydroxy-6-methyloxan-2-yl]oxime}erythromycin; Roxithromycin Related Compound B; Erythromycin 9-{O-[5-(Dimethylamino)-4-hydroxy-6-methyloxan-2-yl]oxime}, Decladinosyl Derivative
EINECS	Contact for details

Quality Control

Every batch of Decladinose Roxithromycin is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation, purity assessment, and impurity profiling. Certificates of Analysis (COA) detailing batch-specific results from techniques such as HPLC, NMR, and MS are available upon request.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%

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