Description

Nevirapine Impurity D CAS NO 1391054-30-0 is a high-purity 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) Nevirapine. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions involved in method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards and product integrity.

Application

• Pharmaceutical Impurity Profiling and Identification in Nevirapine API and finished drug products.
• Analytical Method Development and Validation for HPLC, UPLC, and other chromatographic techniques.
• Quality Control (QC) and Quality Assurance (QA) as a certified reference material for routine batch testing.
• Stability Studies to monitor and quantify the formation of this specific degradation product over time.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA, EMA, and other global health authorities.
• Research and Development (R&D) of Nevirapine synthesis pathways and impurity formation mechanisms.

Basic Information

Product Name	Nevirapine Impurity D
CAS No.	1391054-30-0
Molecular Formula	C15H14N4O
Molecular Weight	266.30 g/mol
Synonyms	Nevirapine Related Compound D; 11-Cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one Impurity; 11-Cyclopropyl-4-methyl-5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one Impurity D; Nevirapine EP Impurity D; Nevirapine USP Impurity D; Nevirapine Process Impurity; Nevirapine Degradant
EINECS	Contact for details

Quality Control

Every batch of Nevirapine Impurity D is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopeial monographs (USP, EP). Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory needs.

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 conditions or in a desiccator to prevent degradation upon exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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