Description

Mupirocin Ep Impurity D is a high-purity chemical reference standard, specifically identified as an impurity of the antibiotic Mupirocin. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is primarily used by research institutions, analytical laboratories, and pharmaceutical companies engaged in the development and production of Mupirocin-based formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Impurity D in Mupirocin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Used to develop and optimize chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Essential for routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Mupirocin to understand degradation pathways.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., ANDA, NDA) with agencies like the FDA and EMA.
• Research & Development: Used in chemical and metabolic studies to understand the properties and behavior of Mupirocin-related substances.

Basic Information

Product Name	Mupirocin Ep Impurity D
CAS No.	71087-97-3
Molecular Formula	C26H44O9
Molecular Weight	500.63 g/mol
Synonyms	Pseudomonic Acid D; (E)-4-[(2S,3R,4R,5S)-5-[(2S,3S,4R,5S)-5-[(2S,3S)-3-[(2S,3S)-3-Hydroxybutan-2-yl]oxiran-2-yl]-3,4-dihydroxy-2-methylpentyl]-3,4-dihydroxyoxan-2-yl]-4-hydroxy-2-methylbut-2-enoic Acid; Mupirocin Impurity D; Bactroban Impurity D; Mupirocin Related Compound D
EINECS	Contact for details

Quality Control

Every batch of Mupirocin Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and other relevant analytical techniques.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to Off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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