Description

Propranolol n-Acetyl Impurity CAS NO 2007-11-6 is a specific process-related impurity and degradation product of the widely used β-blocker, Propranolol Hydrochloride. This compound is critical for pharmaceutical manufacturers and analytical laboratories for method development, validation, and ensuring the purity and safety of the final drug product. It is primarily required by quality control (QC) and research & development (R&D) departments within the pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Propranolol Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure the accuracy and precision of impurity assays.
• Stability Studies: Employed in forced degradation studies to understand the degradation pathways of Propranolol and to establish appropriate shelf-life specifications.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Research on Degradation Chemistry: Used in academic and industrial research to study the metabolic and chemical degradation pathways of β-blocker drugs.

Basic Information

Product Name	Propranolol n-Acetyl Impurity
CAS No.	2007-11-6
Molecular Formula	C16H23NO3
Molecular Weight	277.36 g/mol
Synonyms	1-(Isopropylamino)-3-(naphthalen-1-yloxy)propan-2-yl acetate; N-Acetyl Propranolol; Propranolol N-Acetate; Propranolol Impurity A (Acetyl); 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, acetate (ester); Acetylpropranolol; Propranolol Related Compound A
EINECS	Contact for details

Quality Control

Our Propranolol n-Acetyl Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and accurate characterization, suitable for use as a reference standard. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including identification (IR, NMR), assay (HPLC), and related substance analysis. We adhere to stringent quality management protocols to support our clients' needs for GMP compliance and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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 guidelines

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