Description

Nadolol Ep Impurity F CAS NO 2116-22-5 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the β-blocker Nadolol. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products. It is primarily required by pharmaceutical manufacturers and analytical laboratories for research, method development, and quality control testing of Nadolol API and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Nadolol Ep Impurity F in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Nadolol impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine impurity monitoring in pharmaceutical manufacturing to ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies of Nadolol to understand degradation pathways and establish shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Common Technical Documents (CTD), and regulatory filings with agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study the formation and fate of this impurity during the Nadolol synthesis process.

Basic Information

Product Name	Nadolol Ep Impurity F
CAS No.	2116-22-5
Molecular Formula	C17H27NO4
Molecular Weight	309.40 g/mol
Synonyms	5-[3-(tert-Butylamino)-2-hydroxypropoxy]-1,2,3,4-tetrahydro-2,3-naphthalenediol; (2R,3S)-5-[2-Hydroxy-3-[(1,1-dimethylethyl)amino]propoxy]-1,2,3,4-tetrahydro-2,3-naphthalenediol; Nadolol Impurity F; Nadolol Related Compound F; Nadolol EP Impurity F; Nadolol USP Impurity F; Nadolol Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Nadolol Ep Impurity F is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support your 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 product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
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.