Description

2H,5H-Pyrano[4,3-B]Pyranyl Mupirocin Sodium Impurity is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient Mupirocin Sodium by serving as a key marker for impurity profiling. It is an essential tool for researchers and quality assurance professionals in pharmaceutical companies, contract research organizations (CROs), and analytical testing laboratories who require reliable standards for method validation and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Mupirocin Sodium bulk drug substance and finished formulations.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to ensure accurate detection and measurement.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch release testing to monitor impurity levels and ensure drug products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of this degradation product over time under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive understanding and control of the drug substance's impurity profile.
• Research and Development (R&D): Facilitates process chemistry research aimed at minimizing the formation of this impurity during the synthesis of Mupirocin Sodium.

Basic Information

Product Name	2H,5H-Pyrano[4,3-B]Pyranyl Mupirocin Sodium Impurity
CAS No.	116182-44-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mupirocin Sodium Impurity C; Mupirocin Impurity C; Pseudomonic Acid A Impurity; (E)-5-[(2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-2-furanyl]-3-methyl-2,4-pentadienoic Acid Impurity; Bactroban Impurity; BRL 4910A Impurity; Antibiotic BRL 4910A Impurity; 9-[[3-Methyl-1-oxo-4-[tetrahydro-3,4-dihydroxy-5-[(2S,3S,4S,5S)-2,3-epoxy-5-hydroxy-4-methylhexyl]-2-furanyl]-2-butenyl]oxy]nonanoic Acid Related Compound
EINECS	Contact for details

Quality Control

Every batch of 2H,5H-Pyrano[4,3-B]Pyranyl Mupirocin Sodium Impurity 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 industry standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use in GMP and regulatory environments.

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 should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to Off-white Solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
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.