Description

Dnv-Ii Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a known impurity during method development and validation. It is primarily utilized by research scientists and quality control laboratories in the pharmaceutical and biotechnology sectors for impurity profiling and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to ensure accurate detection limits.
• Quality Control & Assurance: Employed in routine QC testing to monitor batch-to-batch consistency and ensure compliance with ICH guidelines on impurities.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand drug product behavior.
• Academic & Contract Research: Supports fundamental research in synthetic chemistry and pharmacology within academic institutions and CROs.

Basic Information

Product Name	Dnv-Ii Impurity 1
CAS No.	1005324-46-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	DNV-II Impurity 1; Dnv-Ii Related Compound 1; 1005324-46-8; Dnv-Ii Impurity; DNV II Impurity Standard; Dnv-Ii Process Impurity; Dnv-Ii Specified Impurity
EINECS	Contact for details

Quality Control

Our Dnv-Ii Impurity 1 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity and identity confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profiles is provided with every shipment to support your quality and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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