Description

Tobramycinimpurity7 CAS NO 52850-89-2 is a high-purity chemical reference standard, specifically identified as an impurity of the aminoglycoside antibiotic Tobramycin. This compound is critical for analytical research and quality control in pharmaceutical development, ensuring the safety and efficacy of final drug products. It is primarily utilized by research scientists and quality assurance professionals in the pharmaceutical and biotechnology industries for method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying related substances in Tobramycin API and finished drug products.
• Analytical Method Development and Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for purity analysis.
• Quality Control and Assurance (QC/QA): Employed as a system suitability standard and for routine testing in pharmaceutical QC laboratories to monitor impurity levels against ICH guidelines.
• Regulatory Compliance and Submission: Essential for generating data to support regulatory filings (e.g., with FDA, EMA) by providing definitive identification of specified impurities.
• Stability Studies: Used to track the formation and levels of this specific degradation product under various stability-indicating conditions.
• Academic and Contract Research: Supports research into aminoglycoside chemistry, degradation pathways, and analytical science in academic and CRO settings.

Basic Information

Product Name	Tobramycin Impurity 7
CAS No.	52850-89-2
Molecular Formula	C18H37N5O9
Molecular Weight	467.52 g/mol
Synonyms	5-Amino-2-[[(1S,2S,3R,4S,6R)-4,6-diamino-3-[[(2S,3R)-3-amino-6-(aminomethyl)-3,4-dihydro-2H-pyran-2-yl]oxy]-2-hydroxycyclohexyl]oxy]cyclohexane-1,3-diol; Nebramycin Factor 5''; 3''-Deoxykanamycin B; 6'-O-Carbamoylkanamycin B; Kanamycin B 6'-Carbamate; Tobramycin Related Compound; Tobramycin Impurity D; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Tobramycin Impurity 7 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with pharmacopeial standards and customer specifications. 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 in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Assay (on dried basis)	97.0% - 102.0%
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.