Description

Neomycin Sulfate EP Impurity G is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by accurately identifying and quantifying related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and testing of Neomycin Sulfate bulk drug substances and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Neomycin Sulfate API.
• Analytical Research: Used in HPLC, LC-MS, and other chromatographic systems for the identification and quantification of related substances as per pharmacopeial monographs (EP, USP).
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., CMC sections) to agencies like the FDA and EMA, demonstrating control over product impurities.
• Stability Studies: Employed to monitor the formation of degradation products in Neomycin Sulfate formulations under various stress conditions.
• Method Transfer & Verification: Acts as a key component in transferring analytical methods between laboratories or sites for consistent impurity profiling.
• Academic & Contract Research: Supports research in antibiotic chemistry, degradation pathways, and the development of advanced analytical techniques.

Basic Information

Product Name	Neomycin Sulfate EP Impurity G
CAS No.	54617-40-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Neomycin B Sulfate; Neomycin Sulfate Related Compound G; Neomycin Impurity G; 2-Deoxystreptamine, O-2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1→4)-O-[O-2,6-diamino-2,6-dideoxy-β-L-idopyranosyl-(1→3)-β-D-ribofuranosyl-(1→5)]-, sulfate; Neomycin B Sulfate Impurity; EP Impurity G of Neomycin Sulfate
EINECS	Contact for details

Quality Control

Every batch of Neomycin Sulfate EP Impurity G is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic purity analysis, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and analytical data is provided with each shipment and is available upon request.

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 in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content	≤ 5.0%
Residue on Ignition	≤ 1.0%

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