Description

Etimicin Impurity 2 (Netilmicin Ep Impurity B) is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound serves as a specified impurity in the analysis of aminoglycoside antibiotics, primarily Etimicin and Netilmicin, ensuring the safety and efficacy of the final drug product. It is an essential material for analytical laboratories, quality assurance departments, and R&D teams in the pharmaceutical industry focused on method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Etimicin and Netilmicin active pharmaceutical ingredients (APIs) and finished formulations.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure drug substance and drug product purity meets pharmacopeial standards (e.g., USP, EP, ChP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to demonstrate product safety.
• Research & Development: Supports synthetic chemistry research, metabolic studies, and the investigation of structure-activity relationships (SAR) for aminoglycoside antibiotics.

Basic Information

Product Name	Etimicin Impurity 2 (Netilmicin Ep Impurity B)
CAS No.	67666-41-5
Molecular Formula	C21H41N5O7
Molecular Weight	475.59 g/mol
Synonyms	Netilmicin EP Impurity B; Netilmicin Impurity B; 1-N-Ethylsisomicin; 1-N-Ethylsisomicin Sulfate; Etimicin Related Compound B; O-3-Deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→6)-O-[2,6-diamino-2,3,4,6-tetradeoxy-α-D-glycero-hex-4-enopyranosyl-(1→4)]-2-deoxy-D-streptamine; Antibiotic Sch 22591 Impurity; Aminoglycoside Impurity Standard.
EINECS	Contact for details

Quality Control

Every batch of Etimicin Impurity 2 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 pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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 product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent exposure to atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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