Description

Neomycin Impurity 3 is a specified impurity and degradation product of the aminoglycoside antibiotic Neomycin. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method validation and quality control. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies to ensure the purity, safety, and efficacy of Neomycin and related drug substances. The availability of a well-characterized impurity standard is essential for meeting stringent pharmacopeial requirements and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Neomycin Impurity 3 in Neomycin sulfate active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, validating, and verifying HPLC, UPLC, or LC-MS methods to monitor impurities in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to establish impurity profiles, set specification limits, and ensure batch-to-batch consistency of Neomycin-based pharmaceuticals.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability and shelf-life determination studies.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization, qualification, and control strategies.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation mechanisms of Neomycin, helping to improve formulation and packaging strategies.

Basic Information

Product Name	Neomycin Impurity 3
CAS No.	58096-76-7
Molecular Formula	C23H46N6O13
Molecular Weight	614.65 g/mol
Synonyms	Neamine; Neomycin A; 2-Deoxystreptamine, 4-O-(2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl)-; 4-O-(2,6-Diamino-2,6-dideoxy-α-D-glucopyranosyl)-2-deoxystreptamine; D-Neamine; NSC 113926; Neomycin Impurity A; Streptothricin BI
EINECS	Contact for details

Quality Control

Every batch of Neomycin Impurity 3 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) is provided with each shipment, detailing batch-specific results, including purity by HPLC, residual solvents, and water content. We support compliance with ICH guidelines and can supply materials suitable for use as in-house reference standards.

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. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccation. Handle with appropriate laboratory safety practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Specific Rotation	Contact for details

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