Description

Dnv-Ii Impurity 2 is a high-purity chemical reference standard with CAS NO 1133153-38-4, specifically used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products by serving as a benchmark in impurity profiling and method validation. It is an essential material for analytical chemists, quality control laboratories, and R&D departments within the global pharmaceutical and biotechnology industries.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of process-related impurities in active pharmaceutical ingredients (APIs).
• Analytical Method Development and Validation: Serves as a critical component in developing, qualifying, and validating chromatographic methods like HPLC and UPLC.
• Quality Control and Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring final drug product specifications are met.
• Regulatory Compliance and Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug substance impurity profile.
• Stability Studies: Used to track the formation and growth of specific degradants over time under various stress conditions.
• Research and Development: Facilitates studies on degradation pathways and the chemical behavior of pharmaceutical compounds.

Basic Information

Product Name	Dnv-Ii Impurity 2
CAS No.	1133153-38-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	DNV-II Impurity 2; 1133153-38-4; Dnv Ii Related Compound 2; Dnv-Ii Impurity B; Dnv-2 Impurity; Pharmaceutical Impurity Standard; Analytical Reference Standard
EINECS	Contact for details

Quality Control

Every batch of Dnv-Ii Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, and NMR to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA), detailing all test results and specifications, is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white 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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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