Description

Nebivolol Impurity 3 CAS NO 1029684-20-5 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Nebivolol. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for maintaining stringent pharmacopeial standards in drug development and production.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Nebivolol API and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed as a system suitability standard and for routine batch release testing to ensure API purity meets pharmacopeial (USP, EP) specifications.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., ANDA, CTA) to agencies like the FDA and EMA, providing necessary impurity data.
• Stability Studies: Used to monitor the formation and levels of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development (R&D): Utilized in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.

Basic Information

Product Name	Nebivolol Impurity 3
CAS No.	1029684-20-5
Molecular Formula	C22H25F2NO4
Molecular Weight	405.44 g/mol
Synonyms	1,1'-[2,2'-Bis(fluoromethylene)bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-4,2-diyl)]bis(2,2-dimethyl-1-propanol); (4R,4'R)-1,1'-[2,2'-Bis(fluoromethylene)bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-4,2-diyl)]bis(2,2-dimethyl-1-propanol); Nebivolol Related Compound C; Nebivolol Impurity C; UNII-2Y7L4T5Q0F; 2Y7L4T5Q0F; Nebivolol EP Impurity C; Nebivolol USP Impurity C
EINECS	Contact for details

Quality Control

Every batch of Nebivolol Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The container should be kept in a dry, cool, and well-ventilated area. For long-term storage, consider storing under an inert atmosphere to prevent potential degradation.

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%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Assay (HPLC)	97.0% - 103.0% (on anhydrous basis)

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