Description

Mupirocin Ep Impurity E is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient Mupirocin, an important topical antibiotic. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control of Mupirocin API and finished drug products.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to identify and quantify Impurity E in Mupirocin batches.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Stability Studies: Employed to monitor the formation and level of this specific degradation product under various storage conditions.
• Pharmacopoeial Testing: Used to verify compliance with monographs in the European Pharmacopoeia (EP) and other international pharmacopoeias.
• Research & Development: Supports R&D efforts in understanding the degradation pathways and chemistry of Mupirocin.

Basic Information

Product Name	Mupirocin Ep Impurity E
CAS No.	71087-96-2
Molecular Formula	C26H44O9
Molecular Weight	500.63 g/mol
Synonyms	Pseudomonic Acid E; (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]-2-methylbut-2-enoic Acid; Mupirocin Impurity E; Mupirocin Related Compound E
EINECS	Contact for details

Quality Control

Every batch of Mupirocin Ep Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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