Description

Temazepam Impurity D is a specified impurity and degradation product of the benzodiazepine drug Temazepam. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily used by analytical chemists, quality assurance professionals, and researchers in pharmaceutical manufacturing and regulatory testing laboratories to ensure the purity, safety, and efficacy of Temazepam-based drug products.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Temazepam Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Critical component in analytical method development and validation for HPLC, UPLC, and GC assays to meet ICH Q2(R1) and pharmacopeial guidelines.
• Essential for stability studies and forced degradation studies to understand the degradation pathways of Temazepam.
• Used in pharmaceutical quality control (QC) laboratories to monitor impurity profiles and ensure batch-to-batch consistency.
• Serves as a critical reagent in regulatory compliance and submission dossiers for agencies like the FDA, EMA, and PMDA.
• Valuable for academic and clinical research investigating the metabolism, pharmacokinetics, and toxicology of Temazepam.

Basic Information

Product Name	Temazepam Impurity D
CAS No.	17191-70-7
Molecular Formula	C₁₆H₁₃ClN₂O₂
Molecular Weight	300.74 g/mol
Synonyms	7-Chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one; 3-Hydroxydiazepam; Oxydiazepam; Nordazepam Impurity D; Temazepam Related Compound D; 1-Methyl-7-chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepine-2,3-dione (tautomer); 3-Hydroxy-1-methyl-5-phenyl-7-chloro-1,3-dihydro-2H-1,4-benzodiazepin-2-one
EINECS	Contact for details

Quality Control

Every batch of Temazepam Impurity D is manufactured and controlled under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with ICH Q3A/B, USP, and EP guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum corresponds to reference spectrum
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.