Description

Alprazolam Ep Impurity F is a high-purity reference standard critical for analytical method development and validation in pharmaceutical quality control. This compound is essential for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Alprazolam by accurately identifying and quantifying process-related impurities. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in drug development and regulatory compliance. The use of this well-characterized impurity standard is fundamental to meeting stringent pharmacopeial requirements for impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Alprazolam Ep Impurity F in drug substance and finished product testing.
• Analytical Method Development: Used to develop and optimize chromatographic methods, such as HPLC and UPLC, for impurity separation and analysis.
• Quality Control & Assurance: Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines and pharmacopeial monographs (e.g., USP, EP).
• Regulatory Submissions: Critical for preparing impurity profiles and supporting documentation for regulatory filings with agencies like the FDA and EMA.
• Stability Studies: Used as a marker to track impurity formation in stability-indicating methods during forced degradation and long-term stability studies of Alprazolam formulations.
• Research & Development: Supports process chemistry research to understand and minimize the formation of this specific impurity during API synthesis.

Basic Information

Product Name	Alprazolam Ep Impurity F
CAS No.	37945-07-6
Molecular Formula	C₁₇H₁₃ClN₄
Molecular Weight	308.76 g/mol
Synonyms	8-Chloro-1-methyl-6-phenyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine; Alprazolam Impurity F; Alprazolam Related Compound F; Alprazolam EP Impurity F; 1-Methyl-8-chloro-6-phenyl-4H-s-triazolo[4,3-a][1,4]benzodiazepine; Triazolobenzodiazepine Impurity; Xanax Impurity F
EINECS	Contact for details

Quality Control

Every batch of Alprazolam Ep Impurity F is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of the pharmaceutical industry. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for key parameters including assay, related substances, and residual solvents. We support compliance with ICH guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. Keep the container in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 0.5%

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