Description

Ipriflavone Impurity D is a high-purity reference standard critical for analytical research and quality control in pharmaceutical development. This compound is essential for the accurate identification, quantification, and monitoring of related substances in Ipriflavone active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by analytical chemists, quality assurance professionals, and researchers in pharmaceutical and contract research organizations (CROs) to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the calibration of analytical instruments and validation of testing methods in QC labs.
• Method Development and Validation: Critical for developing and validating HPLC, UPLC, and GC methods for impurity profiling of Ipriflavone.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH guidelines.
• Batch Release Testing: Serves as a system suitability standard and impurity marker for the routine quality control and release of Ipriflavone API batches.
• Research and Development: Used in synthetic chemistry research to study degradation pathways and to synthesize purer batches of the main API.

Basic Information

Product Name	Ipriflavone Impurity D
CAS No.	50561-04-1
Molecular Formula	C18H16O3
Molecular Weight	280.32 g/mol
Synonyms	7-Isopropoxy-3-phenyl-4H-1-benzopyran-4-one; 7-Isopropoxyisoflavone; 7-(1-Methylethoxy)-3-phenyl-4H-1-benzopyran-4-one; Ipriflavone Related Compound D; Ipriflavone Impurity 4; Ipriflavone EP Impurity D; Ipriflavone USP Related Compound D
EINECS	Contact for details

Quality Control

Every batch of Ipriflavone Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC, GC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to primary standards.

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 material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of 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 unknown impurity ≤ 0.5%
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.