Description

Estazolam Impurity 1 CAS NO 31709-27-0 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient Estazolam by accurately identifying and quantifying related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in research, development, and compliance testing.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying this specific impurity in Estazolam drug substance and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (HPLC, UPLC, GC) for impurity detection.
• Quality Control and Release Testing: Employed in routine QC laboratories to monitor batch-to-batch consistency and ensure impurity levels meet pharmacopeial (e.g., USP, EP, ICH) guidelines.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Estazolam.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity control strategies to agencies like the FDA and EMA.
• Research and Development: Utilized in synthetic chemistry R&D to study the formation mechanism of this impurity and develop purer synthesis routes.

Basic Information

Item	Detail
Product Name	Estazolam Impurity 1
CAS No.	31709-27-0
Molecular Formula	C16H11ClN4
Molecular Weight	294.74 g/mol
Synonyms	8-Chloro-6-phenyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine; Estazolam Related Compound A; Estazolam EP Impurity A; Estazolam USP Related Compound A; 1,4-Benzodiazepine, 8-chloro-6-phenyl-4H-[1,2,4]triazolo[4,3-a][1,4]-; Triazolobenzodiazepine Impurity
EINECS	Contact for details

Quality Control

Every batch of Estazolam Impurity 1 is manufactured and analyzed under strict quality management systems. The material is characterized using advanced spectroscopic and chromatographic techniques to confirm identity and purity, ensuring it meets the stringent requirements for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and identification tests performed in compliance with current Good Manufacturing Practices (cGMP).

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 under appropriate conditions to maintain stability.

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 unknown impurity ≤ 0.5%
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.