Description

Propiophenone Impurity 2 is a high-purity reference standard and synthetic intermediate of significant importance in pharmaceutical development and quality control. Its primary value lies in its use as a critical analytical marker for ensuring the purity and safety of the active pharmaceutical ingredient (API) Propiophenone and related compounds. This compound is essential for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) involved in method validation, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in Propiophenone API batches.
• Analytical Method Development and Validation: Used as a standard to develop, calibrate, and validate chromatographic methods such as HPLC and GC for purity analysis.
• Regulatory Compliance and Submissions: Critical for preparing impurity data packages required by regulatory bodies like the FDA, EMA, and ICH to support drug applications.
• Chemical Synthesis Research: Acts as a building block or intermediate in organic synthesis for developing novel pharmaceutical compounds or studying reaction pathways.
• Stability Studies: Employed to monitor the formation of degradation products in Propiophenone under various stress conditions (e.g., heat, light, humidity).
• Quality Control Benchmarking: Provides a definitive standard for in-house quality control laboratories to establish specification limits for impurities.

Basic Information

Item	Detail
Product Name	Propiophenone Impurity 2
CAS No.	111000-54-5
Molecular Formula	C9H10O
Molecular Weight	134.18 g/mol
Synonyms	1-Phenylpropan-1-one Impurity 2; Propiophenone Related Compound 2; 1-Phenyl-1-propanone Impurity; Benzyl methyl ketone impurity; Ethyl phenyl ketone impurity; α-Methylacetophenone impurity; Phenyl ethyl ketone derivative; (CAS 111000-54-5)
EINECS	Contact for details

Quality Control

Every batch of Propiophenone Impurity 2 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, GC, NMR, and mass spectrometry, to ensure high chemical purity and structural identity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profiles. We adhere to relevant ICH guidelines for impurity characterization to support our clients' 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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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