Description

trans-Ibuprofen Impurity G is a specified stereoisomeric impurity used as a reference standard in pharmaceutical analysis. Its primary value lies in enabling the precise identification, quantification, and control of related substances during the development and quality assurance of Ibuprofen-based drug products. This compound is essential for analytical chemists and quality control laboratories in the pharmaceutical industry who require high-purity reference materials to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Ibuprofen active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Critical for developing and validating analytical methods, particularly chiral separation techniques like HPLC and UPLC, to monitor stereochemical purity.
• Quality Control (QC) Testing: Used in routine QC testing to ensure Ibuprofen batches meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B) for related substances.
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research and Development: Used in pharmaceutical R&D to study the metabolic pathways, degradation profiles, and synthesis pathways of Ibuprofen.

Basic Information

Product Name	trans-Ibuprofen Impurity G
CAS No.	1391054-15-1
Molecular Formula	C13H18O2
Molecular Weight	206.28 g/mol
Synonyms	(2S,3S)-2-(4-Isobutylphenyl)propanoic Acid; (2S,3S)-Ibuprofen; (S,S)-Ibuprofen; Ibuprofen Impurity G (trans); Ibuprofen Related Compound G; Ibuprofen Stereoisomer Impurity; trans-(S,S)-Ibuprofen; 2-(4-Isobutylphenyl)- (2S,3S)-propanoic Acid
EINECS	Contact for details

Quality Control

Every batch of trans-Ibuprofen Impurity G is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including chromatographic purity, stereochemical identity confirmation, and quantitative assay. A detailed Certificate of Analysis (COA) containing results from HPLC, chiral analysis, NMR, and mass spectrometry is supplied with each shipment to ensure full traceability and compliance with industry best practices.

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) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0% (trans-(S,S) isomer)
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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