Description

Ibuprofen Ep Impurity I CAS NO 2143535-26-4 is a specified impurity and reference standard used in the analytical profiling of Ibuprofen, a widely used non-steroidal anti-inflammatory drug (NSAID). This compound is critical for pharmaceutical quality control, enabling manufacturers to monitor, identify, and quantify related substances to ensure the purity, safety, and efficacy of the final drug product. It is an essential material for analytical laboratories, R&D departments, and quality assurance teams in the pharmaceutical and fine chemical industries involved in method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Ibuprofen Ep Impurity I in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate high-performance liquid chromatography (HPLC), UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch analysis to ensure Ibuprofen API and drug products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., ANDA, NDA, CMC documentation) by providing necessary impurity data for safety and quality assessments.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and impurity formation mechanisms of Ibuprofen.

Basic Information

Product Name	Ibuprofen Ep Impurity I
CAS No.	2143535-26-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibuprofen Impurity I (EP); Ibuprofen Related Compound I; Ibuprofen EP Impurity; Ibuprofen Specified Impurity I; (2RS)-2-[4-(2-Methylpropyl)phenyl]propanoic acid impurity; Ibuprofen Process Impurity; Ibuprofen Degradant; Ibuprofen Related Substance I
EINECS	Contact for details

Quality Control

Our Ibuprofen Ep Impurity I is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for use as a reference standard. Certificates of Analysis (COA) are provided, detailing batch-specific results for purity, assay, and identification. Our quality commitment aligns with the principles of current Good Manufacturing Practice (cGMP) and relevant ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and away from light exposure to maintain stability and purity.

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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%

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