Description

n-Nitrosopropranolol CAS NO 84418-35-9 is a nitrosated derivative of the β-blocker propranolol, primarily utilized as a critical reference standard and impurity marker in pharmaceutical research and development. Its significance lies in its role for analytical method validation, stability studies, and ensuring the safety and purity of propranolol-based drug substances and products. This compound is essential for quality control laboratories, regulatory affairs departments, and research institutions focused on cardiovascular drug development and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of nitrosamine impurities in propranolol active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, calibrate, and validate sensitive analytical methods, such as HPLC-MS/MS and GC-MS, for nitrosamine detection.
• Forced Degradation & Stability Studies: Employed in stress testing protocols to understand the degradation pathways of propranolol and to establish impurity limits.
• Regulatory Compliance & Safety Assessment: Critical for meeting stringent global regulatory requirements (e.g., FDA, EMA, ICH) regarding the control of potentially mutagenic nitrosamine impurities.
• Research on Nitrosamine Formation: Used as a model compound in studies investigating the mechanisms and conditions of nitrosamine formation in pharmaceutical matrices.
• Quality Control & Batch Release Testing: An essential component in the QC testing suite to ensure batch-to-batch consistency and patient safety.

Basic Information

Product Name	n-Nitrosopropranolol
CAS No.	84418-35-9
Molecular Formula	C16H24N2O3
Molecular Weight	292.38 g/mol
Synonyms	N-Nitrosopropranolol; Propranolol Nitrosamine; 1-Isopropylamino-3-(1-naphthyloxy)-2-propanol N-Nitroso Derivative; N-Nitroso-1-(isopropylamino)-3-(naphthalen-1-yloxy)propan-2-ol; N-Nitroso Propranolol; Nitrosopropranolol Impurity; Propranolol Related Compound N-Nitroso; NPRO
EINECS	Contact for details

Quality Control

Every batch of n-Nitrosopropranolol is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic and spectroscopic techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool, and well-ventilated area. Keep the container sealed to protect from moisture and contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	90.0% - 110.0% (on dried basis)
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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