Description

Retapamulin Impurity CAS NO 35136-87-9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic Retapamulin by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments engaged in the development and manufacture of topical antibiotic formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Retapamulin active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating chromatographic methods, such as HPLC and UPLC, for stability-indicating assays.
• Quality Control & Assurance: Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation and growth of specific impurities over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CMC sections) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Facilitates studies on the degradation pathways and chemical behavior of Retapamulin, aiding in process optimization and formulation science.

Basic Information

Product Name	Retapamulin Impurity
CAS No.	35136-87-9
Molecular Formula	C30H47NO4S
Molecular Weight	517.77 g/mol
Synonyms	(3aS,4R,5S,6S,8R,9R,9aR,10R)-6-Ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxo-5,6,8,9,9a,10-hexahydro-3aH-cyclopenta[b]naphtho[2,3-d]furan-8-yl 2-(diethylamino)acetate; Retapamulin Related Compound; (1S,2S,4R,7S,8S,11S,13S)-13-[(2S)-5-(Diethylamino)-2-hydroxy-2-methylpentanoyl]-7-ethenyl-2-hydroxy-4,8,11,13-tetramethyl-3,14-dioxatricyclo[8.4.0.0²,⁷]tetradecan-6-one; SB-275833 Impurity
EINECS	Contact for details

Quality Control

Our Retapamulin Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure high purity and identity confirmation, aligning with ICH guidelines for impurity standards. Comprehensive Certificates of Analysis (COA) are provided, detailing results from HPLC purity assay, related substance analysis, and structural confirmation via spectroscopic methods (NMR, MS).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

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

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