Description

Bromazepam Impurity 3 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Bromazepam during its development and manufacturing. It is an essential tool for researchers and quality assurance professionals in the pharmaceutical industry who require precise identification and quantification of impurities. The use of this well-characterized impurity standard is fundamental for meeting stringent global regulatory requirements for drug substances.

Application

• Primary use as a certified reference standard for the identification and quantification of Bromazepam Impurity 3 in API batches.
• Critical component in analytical method development and validation (e.g., HPLC, UPLC, GC) for Bromazepam.
• Used in stability studies and forced degradation studies to monitor impurity profiles over time.
• Essential for pharmaceutical research and development to understand degradation pathways.
• Serves as a system suitability standard in quality control (QC) laboratories to ensure analytical instrument performance.
• Supports regulatory filings (e.g., ANDA, NDA) by providing impurity characterization data for health authorities.
• Used in the calibration of analytical equipment for precise impurity measurement.

Basic Information

Item	Detail
Product Name	Bromazepam Impurity 3
CAS No.	40951-53-9
Molecular Formula	C14H10BrN3O
Molecular Weight	316.15 g/mol
Synonyms	7-Bromo-5-(pyridin-2-yl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one; 3H-1,4-Benzodiazepin-2(1H)-one, 7-bromo-5-(2-pyridinyl)-; Bromazepam Impurity C; Bromazepam Related Compound C; Bromazepam EP Impurity C; Bromazepam USP Related Compound C; 7-Bromo-5-(2-pyridinyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one
EINECS	Contact for details

Quality Control

Every batch of Bromazepam Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

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)	≤ 0.5%

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