Description

Sulfamethoxazole Impurity 9 is a designated reference standard used for the analytical profiling and quality control of the antibiotic Sulfamethoxazole. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product by identifying and quantifying process-related impurities. It is an essential tool for research and development, method validation, and regulatory compliance within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for calibrating analytical instruments and validating testing methods.
• Quality Control & Assurance (QC/QA): Critical for monitoring and controlling impurity levels in Sulfamethoxazole Active Pharmaceutical Ingredient (API) batches to meet pharmacopeial specifications (USP, EP, BP).
• Research & Development (R&D): Used in stability studies, degradation pathway elucidation, and formulation development to understand impurity behavior.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing definitive impurity identification and characterization data.
• Method Development and Validation: Serves as a key component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity detection.
• Contract Testing Laboratories: Employed by third-party labs offering analytical services to pharmaceutical companies for batch release testing.

Basic Information

Product Name	Sulfamethoxazole Impurity 9
CAS No.	51821-47-7
Molecular Formula	C10H11N3O3S
Molecular Weight	253.28 g/mol
Synonyms	4-Amino-N-(5-methyl-3-isoxazolyl)benzenesulfonamide; N1-(5-Methyl-3-isoxazolyl)sulfanilamide; Sulfamethoxazole Impurity B (EP); Sulfamethoxazole Related Compound B; SMZ Impurity 9; 51821-47-7; Sulfanilamide, N1-(5-methyl-3-isoxazolyl)-
EINECS	Contact for details

Quality Control

Every batch of Sulfamethoxazole Impurity 9 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR), purity assessment by HPLC, and determination of residual solvents to ensure it meets the high standards required for a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified analytical procedures and purity criteria.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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. Ensure the container is sealed immediately after use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (by HPLC)	≥ 98.0%
Related Substances (by HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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