Description

Temazepam Related Compound F (15 Mg) (7-Chloro-1-Methyl-5-Phenyl-4,5-Dihydro-1H-1,4-Benzodiazepine-2,3-Dione) is a high-purity analytical reference standard critical for pharmaceutical research and quality control. This compound is essential for ensuring the accuracy and reliability of analytical methods used in drug development and manufacturing. It is primarily used by analytical chemists, quality assurance laboratories, and research institutions involved in the synthesis, impurity profiling, and regulatory compliance testing of benzodiazepine-based active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities or degradation products in Temazepam and related benzodiazepine APIs.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods such as HPLC, UPLC, and GC for purity and stability-indicating assays.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing within pharmaceutical manufacturing to monitor batch-to-batch consistency and ensure final product purity meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Acts as a reference point in forced degradation and long-term stability studies to identify and track the formation of related substances in drug formulations.
• Regulatory Compliance and Documentation: Provides essential data for regulatory submissions (e.g., to FDA, EMA) by supporting impurity identification reports and demonstrating control of the manufacturing process.
• Academic and Clinical Research: Used in metabolic studies, pharmacological research, and forensic analysis to understand the chemistry and bioactivity of benzodiazepine compounds.

Basic Information

Product Name	Temazepam Related Compound F (15 Mg) (7-Chloro-1-Methyl-5-Phenyl-4,5-Dihydro-1H-1,4-Benzodiazepine-2,3-Dione)
CAS No.	3294-96-0
Molecular Formula	C₁₇H₁₃ClN₂O₂
Molecular Weight	312.75 g/mol
Synonyms	7-Chloro-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepine-2,3-dione; 1,4-Benzodiazepine-2,3-dione, 7-chloro-1-methyl-5-phenyl-4,5-dihydro-1H-; Temazepam Impurity F; Temazepam Related Substance F; Oxazepam Impurity C; 3294-96-0; 7-Chloro-1-methyl-5-phenyl-4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione
EINECS	Contact for details

Quality Control

Our Temazepam Related Compound F 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 high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each unit, detailing batch-specific results for purity, impurities, and other critical parameters. Our quality commitment aligns with the expectations of GMP/GLP environments and supports compliance with major pharmacopeias.

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 product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, the container must be kept tightly sealed in a desiccated environment to maintain stability and purity. Avoid prolonged exposure to humidity and elevated temperatures.

Specification

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

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