Description

Indometacin Ep Impurity G is a high-purity reference standard used in the analytical profiling and quality control of the non-steroidal anti-inflammatory drug (NSAID) Indomethacin. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification and quantification of specific process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments focused on method development, validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development and validation in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Analytical Method Development: Used to establish and optimize HPLC, UPLC, or LC-MS methods for the separation and detection of impurities in Indomethacin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Quality Control & Batch Release: Employed as a system suitability and identification marker in routine QA/QC testing to monitor impurity levels and ensure batch-to-batch consistency.
• Stability Studies: A key component in forced degradation and long-term stability studies to track the formation of degradation products.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Pharmacopeial Testing: Supports compliance testing against specifications outlined in the European Pharmacopoeia (EP), United States Pharmacopeia (USP), and other international pharmacopeias.

Basic Information

Item	Details
Product Name	Indometacin Ep Impurity G
CAS No.	402849-26-7
Molecular Formula	C19H16ClNO4
Molecular Weight	357.79 g/mol
Synonyms	1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid; Indomethacin Impurity G; Indomethacin Related Compound G; EP Impurity G of Indometacin; Indometacin Impurity G (EP); 1H-Indole-3-acetic acid, 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-; 402849-26-7
EINECS	Contact for details

Quality Control

Every batch of Indometacin Ep Impurity G is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with each lot, confirming identity, purity, and compliance with in-house specifications aligned with pharmacopeial expectations. Our commitment to traceability, consistency, and data integrity supports your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The container should be kept in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.