Description

Neomycin Impurity B(Ep) is a specified impurity and reference standard used in the pharmaceutical quality control process. This compound is critical for ensuring the purity, safety, and efficacy of the antibiotic Neomycin and related pharmaceutical preparations. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Neomycin Impurity B in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), LC-MS, or other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor and control impurity levels, ensuring compliance with pharmacopoeial standards (e.g., USP, EP, BP).
• Stability Studies: Employed in forced degradation and long-term stability studies of Neomycin to understand degradation pathways and establish shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research & Development: Used in academic and industrial R&D to study the chemical properties, metabolism, and toxicity profile of Neomycin-related substances.

Basic Information

Product Name	Neomycin Impurity B(Ep)
CAS No.	54617-39-9
Molecular Formula	C₁₂H₂₆N₄O₆
Molecular Weight	322.36 g/mol
Synonyms	Neamine; Neomycin A; 2-Deoxystreptamine, O-6-amino-6-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1→6)]-; 2-Deoxystreptamine, O-6-amino-6-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1→6)]-; 4-O-(6-Amino-6-deoxy-α-D-glucopyranosyl)-6-O-(2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl)-2-deoxystreptamine; Neomycin Impurity B (EP); Neomycin Related Compound B
EINECS	Contact for details

Quality Control

Our Neomycin Impurity B(Ep) is manufactured and tested under strict quality management systems. Each batch is characterized and qualified using advanced analytical techniques to ensure identity, purity, and traceability as a pharmaceutical reference standard. Comprehensive Certificates of Analysis (COA) are provided, detailing results from tests such as HPLC purity, water content, residue on ignition, and spectroscopic identification. We support compliance with USP, European Pharmacopoeia (EP), and ICH guidelines for impurities.

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) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%

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