Description

Alprazolam Ep Impurity H is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound is essential for the accurate identification, quantification, and monitoring of a specified impurity during the development and manufacturing of Alprazolam, an important active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify and quantify Impurity H in Alprazolam drug substance and finished products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to ensure Alprazolam batches meet the specified impurity limits as per EP, USP, or ICH guidelines.
• Stability Studies and Forced Degradation Testing: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., CMC sections for FDA, EMA) to demonstrate thorough impurity control strategies.
• Research and Development: Facilitates research into the synthesis pathway, degradation mechanisms, and toxicological significance of Alprazolam-related impurities.

Basic Information

Product Name	Alprazolam Ep Impurity H
CAS No.	2203515-05-1
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 Impurity H; Alprazolam Related Compound H; Alprazolam Impurity H (EP); 1-Methyl-6-phenyl-8-chloro-4H-s-triazolo[4,3-a][1,4]benzodiazepine Impurity; Triazolobenzodiazepine Impurity H; Alprazolam EP Impurity H; Alprazolam Specified Impurity H
EINECS	Contact for details

Quality Control

Every batch of Alprazolam Ep Impurity H is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches 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
Water Content (KF)	≤ 1.0%

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