Description

Nifuratel Impurity 33 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Nifuratel through rigorous analytical control. It is primarily required by analytical chemists and quality assurance professionals in the pharmaceutical and biotechnology sectors. This impurity standard is essential for method validation, stability studies, and regulatory compliance filings.

Application

• Pharmaceutical Impurity Profiling and Identification in the analysis of Nifuratel API and finished dosage forms.
• Analytical Method Development and Validation (HPLC, UPLC, LC-MS) for accurate quantification of related substances.
• Quality Control and Stability Testing to monitor impurity levels throughout the drug product lifecycle.
• Regulatory Submission Support for ANDA, NDA, and other global drug master files requiring detailed impurity characterization.
• Reference Standard for Pharmacopoeial Testing, supporting compliance with USP, EP, and ICH guidelines (Q3A, Q3B).
• Research and Development of synthetic pathways and degradation studies for Nifuratel.

Basic Information

Product Name	Nifuratel Impurity 33
CAS No.	14360-12-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nifuratel Related Compound 33; Nifuratel Impurity C; 5-(Methylamino)-3-[(5-nitrofurfurylidene)amino]-2-oxazolidinone; 1-(5-Nitro-2-furyl)-3-(methylamino)-2-imidazolidinone (alternative representation); 14360-12-4; Nifuratel EP Impurity C; Nifuratel USP Impurity; Nitrofurantoin analogue impurity
EINECS	Contact for details

Quality Control

Every batch of Nifuratel Impurity 33 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and impurity profile testing to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced chromatographic and spectroscopic analyses. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The material should be kept in its original packaging under inert conditions to ensure long-term stability. Avoid exposure to moisture and excessive heat.

Specification

Item	Specification
Appearance	Off-white to light yellow powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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