Description

Sulfamethoxazole Related Compound F is a high-purity chemical reference standard, essential for analytical and quality control processes in the pharmaceutical industry. This compound serves as a critical impurity marker for ensuring the safety and efficacy of the antibiotic Sulfamethoxazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing. The product is supplied with comprehensive documentation to support rigorous quality assurance protocols.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of related substances in Sulfamethoxazole Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: A critical component for developing, calibrating, and validating HPLC, UPLC, or GC analytical methods in quality control laboratories.
• Stability Indicating Studies: Employed in forced degradation and shelf-life studies to monitor the formation of specific degradation products over time.
• Regulatory Compliance & Documentation: Supports compliance with stringent pharmacopeial standards (USP, EP, BP) and regulatory submissions (FDA, EMA) by providing a traceable impurity standard.
• Quality Control Testing: Serves as a system suitability standard and a quantitative marker in the routine batch release testing of Sulfamethoxazole.
• Research & Development: Utilized in pharmaceutical R&D for studying the metabolism, degradation pathways, and synthesis purity of sulfonamide antibiotics.

Basic Information

Product Name	Sulfamethoxazole Related Compound F
CAS No.	17103-52-5
Molecular Formula	C10H11N3O3S
Molecular Weight	253.28 g/mol
Synonyms	4-Amino-N-(5-methyl-3-isoxazolyl)benzenesulfonamide; N1-(5-Methylisoxazol-3-yl)sulfanilamide; Sulfamethoxazole Impurity F; Sulfamethoxazole EP Impurity F; Sulfamethoxazole Related Substance F; SMZ Related Compound F; Benzenesulfonamide, 4-amino-N-(5-methyl-3-isoxazolyl)-
EINECS	Contact for details

Quality Control

Every batch of Sulfamethoxazole Related Compound F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters. We support compliance with USP, EP, and ICH guidelines.

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 dry environment 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 matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 0.5%

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