Description

Nadolol Ep Impurity D CAS NO 67247-26-1 is a specified impurity and reference standard used in the analytical profiling of the β-blocker pharmaceutical, Nadolol. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in the development, production, and regulatory compliance of Nadolol and related generics.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Nadolol Ep Impurity D in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or GC methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Nadolol API and drug products meet stringent pharmacopeial purity specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and the development of improved purification processes for Nadolol.

Basic Information

Product Name	Nadolol Ep Impurity D
CAS No.	67247-26-1
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 D; Nadolol Related Compound D; Nadolol EP Impurity D; Nadolol European Pharmacopoeia Impurity D
EINECS	Contact for details

Quality Control

Every batch of Nadolol Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopeial monographs. Comprehensive characterization is performed using advanced analytical techniques such as HPLC, GC, NMR, and MS. A detailed Certificate of Analysis (COA) providing batch-specific purity, identity, and impurity profile data is available upon request.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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