Description

Nizatidine Impurity CAS NO 68686-34-0 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 (API) Nizatidine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in Nizatidine API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or GC methods to ensure accurate impurity detection.
• Quality Control and Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to confirm that impurity levels are within ICH/USP/EP specified limits.
• Stability Studies: Used to track the formation and growth of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions and Compliance: Essential for generating data required for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization as per ICH Q3A/B guidelines.
• Research and Development (R&D): Utilized in pharmaceutical R&D to study degradation pathways, synthesis by-products, and the overall purity of Nizatidine.

Basic Information

Item	Detail
Product Name	Nizatidine Impurity
CAS No.	68686-34-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nizatidine Related Compound; Nizatidine Process Impurity; Nizatidine Degradant; N-[2-[[[2-[(Dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine; 1,1-Ethenediamine, N-[2-[[[2-[(dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N'-methyl-2-nitro-; Impurity of Nizatidine
EINECS	Contact for details

Quality Control

Our Nizatidine Impurity standard is manufactured and tested under strict quality systems. Each batch is characterized using advanced analytical techniques including HPLC, GC, MS, and NMR to confirm identity and purity. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, batch-specific results, and traceability information. The material is suitable for use in regulated environments, supporting compliance with ICH, USP, and EP guidelines for impurity standards.

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 under inert atmosphere or in a desiccator after opening to prevent degradation. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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