Description

Efavirenz Ip Impurity A CAS NO 353270-77-6 is a high-purity reference standard specifically used in the pharmaceutical development and quality control of Efavirenz, a critical antiretroviral medication. This impurity is essential for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by providing a benchmark for identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and validation of HIV/AIDS treatments.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analytical method development and validation of Efavirenz API.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control impurity levels, ensuring product consistency and compliance with pharmacopeial limits (e.g., USP, EP).
• Regulatory Submission & Compliance: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Stability Studies: Employed to identify and track degradation products in Efavirenz formulations under various stress conditions.
• Research & Development (R&D): Utilized in process chemistry research to understand impurity formation pathways and optimize synthesis routes for purer API.
• Calibration of Analytical Instruments: Acts as a precise calibrant for HPLC, LC-MS, and other chromatographic systems used in pharmaceutical analysis.

Basic Information

Product Name	Efavirenz Ip Impurity A
CAS No.	353270-77-6
Molecular Formula	C14H9ClF3NO2
Molecular Weight	315.67 g/mol
Synonyms	Efavirenz Impurity A; (4S)-6-Chloro-4-(2-cyclopropylethynyl)-4-(trifluoromethyl)-2,4-dihydro-1H-3,1-benzoxazin-2-one; 6-Chloro-4-(2-cyclopropylethynyl)-4-(trifluoromethyl)-1,4-dihydro-2H-3,1-benzoxazin-2-one; Efavirenz Related Compound A; Efavirenz EP Impurity A; Efavirenz USP Impurity A
EINECS	Contact for details

Quality Control

Our Efavirenz Ip Impurity A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards. Our quality commitment supports your regulatory needs for GMP and ICH guideline compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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