Description

Nitazoxanide Impurity 2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Nitazoxanide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for maintaining stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Nitazoxanide API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating stability-indicating methods to monitor impurity profiles during drug development and manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify the control strategy for Nitazoxanide.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways and impurity fate of Nitazoxanide.

Basic Information

Product Name	Nitazoxanide Impurity 2
CAS No.	952686-58-7
Molecular Formula	C12H9N3O5S
Molecular Weight	307.28 g/mol
Synonyms	2-[(5-Nitro-1,3-thiazol-2-yl)carbamoyl]phenyl Acetate; 2-[(5-Nitro-2-thiazolyl)carbamoyl]phenyl Acetate; Nitazoxanide Related Compound; Nitazoxanide Degradant; Nitazoxanide Process Impurity; Acetylsalicylic Acid Derivative of Nitazoxanide; NTZ Impurity 2
EINECS	Contact for details

Quality Control

Every batch of Nitazoxanide Impurity 2 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR), purity determination by HPLC, and control of residual solvents and moisture. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH Q3A(R2) and Q3B(R2) guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere when appropriate to ensure long-term stability.

Specification

Item	Specification
Appearance	Off-white to pale yellow solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 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.