Description

Nitazoxanide Impurity CAS NO 402848-76-4 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 precise characterization of this impurity is essential for meeting stringent pharmacopeial standards and ensuring drug efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Nitazoxanide API and its finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, or GC methods to accurately identify and quantify this specific impurity.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Stability Studies: Employed in forced degradation and long-term stability studies of Nitazoxanide to monitor impurity profiles over time and under various stress conditions.
• Research & Development: Serves as a key material in pharmaceutical R&D for studying the degradation pathways, synthesis impurities, and metabolism of Nitazoxanide.
• Pharmacopeial Testing: Used to comply with testing requirements outlined in pharmacopeias such as USP, EP, or BP for Nitazoxanide monographs.

Basic Information

Product Name	Nitazoxanide Impurity
CAS No.	402848-76-4
Molecular Formula	C12H9N3O5S
Molecular Weight	307.28 g/mol
Synonyms	2-[(5-Nitro-1,3-thiazol-2-yl)carbamoyl]phenyl acetate; 2-Acetoxy-N-(5-nitro-2-thiazolyl)benzamide; Nitazoxanide Related Compound; Nitazoxanide Acetyl Impurity; NTZ Impurity; 2'-Acetyl Nitazoxanide; O-Acetyl Nitazoxanide
EINECS	Contact for details

Quality Control

Every batch of Nitazoxanide Impurity (CAS 402848-76-4) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, 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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w
Heavy Metals	≤ 20 ppm

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