Description

Temazepam Related Compound G (15 Mg) (7-Chloro-1,4-Dimethyl-5-Phenyl-4,5-Dihydro-1H-1,4-Benzodiazepine-2,3-Dione) is a high-purity reference standard and pharmaceutical intermediate essential for quality control and research. This compound is critical for ensuring the accuracy and reliability of analytical methods in pharmaceutical development and manufacturing. It is primarily used by analytical laboratories, quality assurance departments, and research institutions working with benzodiazepine-based active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification, purity assessment, and quantification of temazepam and related substances in drug products and raw materials.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, GC, and LC-MS methods for impurity profiling and stability studies.
• Pharmacological Research: Employed in preclinical and clinical studies as a metabolite or degradation product marker to understand the pharmacokinetics and stability profile of benzodiazepines.
• Quality Control (QC) Testing: Essential for routine QC testing in pharmaceutical manufacturing to monitor impurities as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Forensic Analysis: Used as a standard in forensic toxicology for the accurate identification and measurement of benzodiazepine derivatives in biological samples.

Basic Information

Product Name	Temazepam Related Compound G (15 Mg) (7-Chloro-1,4-Dimethyl-5-Phenyl-4,5-Dihydro-1H-1,4-Benzodiazepine-2,3-Dione)
CAS No.	93329-92-1
Molecular Formula	C₁₇H₁₅ClN₂O₂
Molecular Weight	314.77 g/mol
Synonyms	7-Chloro-1,4-dimethyl-5-phenyl-4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione; Temazepam Impurity G; Temazepam Related Substance G; 1,4-Benzodiazepine-2,3-dione, 7-chloro-1,4-dimethyl-5-phenyl-4,5-dihydro-; Temazepam EP Impurity G; Temazepam USP Related Compound G; 7-Chloro-1,4-dimethyl-5-phenyl-1,4-dihydro-2H-benzo[e][1,4]diazepine-2,3-dione
EINECS	Contact for details

Quality Control

Our Temazepam Related Compound G is manufactured under strict quality systems to ensure it meets the exacting standards required for reference materials. Each batch is subjected to comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR) and purity determination by chromatographic techniques (HPLC). Certificates of Analysis (COA) are provided, detailing batch-specific results and confirming compliance with relevant pharmacopeial standards (USP, EP) where applicable. We are committed to traceability, stability, and reliability for all our reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container tightly sealed in a dry environment.

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 individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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