Description

Mupirocin Impurity P/Decyl [2E,8[2S,3S(1S,2S)]]-5,9-Anhydro-2,3,4,8-tetradeoxy-8-[[3-(2-hydroxy-1-methylpropyl)oxiranyl]methyl]-3-methyl-L-talo-Non-2-enonic Acid Ester is a high-purity chemical reference standard, specifically identified as a process-related impurity of the antibiotic Mupirocin. This compound is critical for pharmaceutical research and development, enabling the accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is an essential material for analytical laboratories, quality control departments, and regulatory affairs teams within the pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Mupirocin and its related substances.
• Method Development and Validation: Critical for developing and validating analytical methods, such as HPLC and LC-MS, for impurity profiling in Mupirocin API and finished dosage forms.
• Quality Control and Assurance: Used in routine QC testing to monitor and control the level of this specific impurity, ensuring batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for impurity identification.
• Stability Studies: Employed in forced degradation and long-term stability studies of Mupirocin to understand degradation pathways and impurity formation.
• Research and Development: Serves as a key intermediate or marker in synthetic chemistry research aimed at optimizing the Mupirocin manufacturing process.

Basic Information

Product Name	Mupirocin Impurity P/Decyl [2E,8[2S,3S(1S,2S)]]-5,9-Anhydro-2,3,4,8-tetradeoxy-8-[[3-(2-hydroxy-1-methylpropyl)oxiranyl]methyl]-3-methyl-L-talo-Non-2-enonic Acid Ester
CAS No.	153900-96-0
Molecular Formula	C26H44O8
Molecular Weight	484.63 g/mol
Synonyms	Mupirocin Impurity P; Pseudomonic Acid A Impurity P; Decyl (2E,8[2S,3S(1S,2S)])-5,9-Anhydro-2,3,4,8-tetradeoxy-8-[[3-(2-hydroxy-1-methylpropyl)oxiranyl]methyl]-3-methyl-L-talo-non-2-enonate; Bactroban Impurity P; (2E,8[2S,3S(1S,2S)])-5,9-Anhydro-2,3,4,8-tetradeoxy-8-[[3-(2-hydroxy-1-methylpropyl)oxiranyl]methyl]-3-methyl-L-talo-non-2-enonic Acid, Decyl Ester; Mupirocin Related Compound P; Antibiotic Pseudomonic Acid A Impurity P
EINECS	Contact for details

Quality Control

Every batch of Mupirocin Impurity P is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, assay, purity (by HPLC), and specified impurities. We support compliance with ICH Q3A, Q3B, and Q6A guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The compound is hygroscopic (moisture-sensitive); ensure containers are sealed after each use to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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