Description

Nebivolol Impurity 12 Hcl (Rr,Rr) CAS NO 920275-25-8 is a high-purity chemical reference standard, specifically the (Rr,Rr) stereoisomer of a key impurity associated with the β-blocker Nebivolol. This compound is critical for pharmaceutical research, development, and quality control, enabling precise identification, quantification, and monitoring of this specific impurity during drug substance and product manufacturing. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify and quantify Nebivolol Impurity 12 in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure that impurity levels in commercial Nebivolol batches remain within International Council for Harmonisation (ICH) guidelines.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity control strategies.
• Research on Synthesis Pathways and Purification Processes: Used by process chemists to study and optimize synthesis routes to minimize the formation of this impurity.

Basic Information

Product Name	Nebivolol Impurity 12 Hcl (Rr,Rr)
CAS No.	920275-25-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(1S,1'S)-1,1'-[(2R,2'R)-2,2'-(2,2-Dimethyl-1,3-dioxolane-4,5-diyl)bis(2-hydroxyethane-2,1-diyl)]bis(6-fluoro-3,4-dihydro-2H-1-benzopyran) Hydrochloride; (Rr,Rr)-Nebivolol Related Compound; Nebivolol EP Impurity H; Nebivolol Diastereomer Impurity; 1,1'-[(2R,2'R)-2,2'-(2,2-Dimethyl-1,3-dioxolane-4,5-diyl)bis(2-hydroxyethane-2,1-diyl)]bis(6-fluoro-3,4-dihydro-2H-chromene) Hydrochloride; UNII-9U8V7FWS4T (component); BRL 37344 Impurity
EINECS	Contact for details

Quality Control

Our Nebivolol Impurity 12 Hcl (Rr,Rr) is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high chemical purity and accurate stereochemical identity, meeting the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) are provided with each shipment, detailing purity, assay, and identification results. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which may affect stability and purity. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Specific Optical Rotation	Contact for details
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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