Description

Sulfamethoxazole Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for quality control and regulatory compliance in the pharmaceutical industry, specifically for the antibiotic Sulfamethoxazole. It is essential for laboratories and manufacturers focused on method development, impurity profiling, and ensuring drug safety and efficacy. This standard supports rigorous pharmacopeial testing and stability studies.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Sulfamethoxazole API and finished dosage forms.
• Method Development and Validation in analytical laboratories using HPLC, UPLC, or LC-MS techniques.
• Stability Studies and forced degradation studies to monitor impurity formation over time.
• Quality Assurance/Quality Control (QA/QC) to ensure batch-to-batch consistency and compliance with ICH, USP, or EP guidelines.
• Regulatory Submissions, providing essential data for drug master files (DMFs) and new drug applications (NDAs).
• Research and Development for studying the degradation pathways and metabolism of Sulfamethoxazole.

Basic Information

Product Name	Sulfamethoxazole Impurity 1
CAS No.	1416441-24-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sulfamethoxazole Related Compound 1; Sulfamethoxazole Degradant; Sulfamethoxazole Process Impurity; 4-Amino-N-(5-methyl-3-isoxazolyl)benzenesulfonamide Impurity; SMZ Impurity 1; Sulfamethoxazole Specified Impurity; Antibiotic Sulfonamide Impurity
EINECS	Contact for details

Quality Control

Our Sulfamethoxazole Impurity 1 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity and identity confirmation, to ensure it meets the exacting standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) with batch-specific data is provided with every shipment, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle with standard laboratory precautions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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