Description

Pranoprofen Impurity 11 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Pranoprofen. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and routine quality control testing.

Application

• Pharmaceutical Impurity Profiling and Identification in Pranoprofen API and finished drug products.
• Analytical Method Development and Validation (HPLC, LC-MS) for accurate quantification of impurities.
• Quality Control (QC) and Quality Assurance (QA) testing to meet ICH, USP, and EP guidelines.
• Stability Studies to monitor impurity formation under various storage conditions.
• Regulatory Documentation and Submission to agencies like the FDA and EMA.
• Research and Development of Pranoprofen synthesis pathways and degradation studies.
• Calibration Standard for analytical instrumentation in contract research organizations (CROs).

Basic Information

Product Name	Pranoprofen Impurity 11
CAS No.	52549-44-7
Molecular Formula	C15H13NO3
Molecular Weight	255.27 g/mol
Synonyms	2-(5H-[1]Benzopyrano[2,3-b]pyridin-7-yl)propanoic Acid; Pranoprofen Related Compound; Pranoprofen Degradation Product; Pranoprofen Process Impurity; 7-(1-Carboxyethyl)-5H-[1]benzopyrano[2,3-b]pyridine; 2-(7,8-Dihydro-5H-[1]benzopyrano[2,3-b]pyridin-7-yl)propanoic Acid; Pranoprofen Impurity B (may be designated); CAS 52549-44-7
EINECS	Contact for details

Quality Control

Every batch of Pranoprofen Impurity 11 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against established specifications. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
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
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.