Description

Nebivolol Impurity 10 Hcl (Rs,Sr) is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Nebivolol by accurately identifying and quantifying related substances. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical research, manufacturing, and regulatory compliance. The product is supplied with a detailed Certificate of Analysis to guarantee its identity and purity for its intended use.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the calibration of analytical equipment (HPLC, LC-MS) in Nebivolol API testing.
• Method Development and Validation: Crucial for developing and validating precise analytical methods to monitor impurities in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control (QC) Testing: Used in routine QC laboratories to ensure Nebivolol drug substances and products meet stringent pharmacopeial (USP, EP) purity specifications.
• Stability Studies: Employed to identify and track degradation products formed during the stability testing of Nebivolol formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports synthetic route optimization and impurity profiling during the R&D phase of Nebivolol and related compounds.

Basic Information

Product Name	Nebivolol Impurity 10 Hcl (Rs,Sr)
CAS No.	920275-23-6
Molecular Formula	C22H26F2NO4 • HCl
Molecular Weight	451.91 g/mol (Free base: 414.45 g/mol)
Synonyms	Nebivolol Related Compound H; (RS,SR)-Nebivolol Impurity 10 Hydrochloride; 1-(6-Fluorochroman-2-yl)-2-{[2-(6-fluorochroman-2-yl)-2-hydroxyethyl]amino}ethanol hydrochloride; UNII-8K6L5VU3WQ; Nebivolol EP Impurity H; Nebivolol USP Impurity H; (R*,S*)-Nebivolol Impurity 10 HCl; 920275-23-6
EINECS	Contact for details

Quality Control

Every batch of Nebivolol Impurity 10 Hcl (Rs,Sr) is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR), purity determination by HPLC, and control of specific impurities. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all test results against established specifications. Our quality commitment aligns with cGMP principles to support our clients' regulatory needs.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be opened under dry, inert conditions when possible.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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