Description

Etodolac Related Compound A (25 Mg) ((+/-)-8-Ethyl-1-Methyl-1,3,4,9-Tetrahydropyrano [3,4-B]-Indole-1-Acetic Acid) is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a key impurity marker and analytical standard for ensuring the quality, safety, and efficacy of the non-steroidal anti-inflammatory drug (NSAID) Etodolac. It is an essential material for analytical chemists and quality control laboratories in pharmaceutical manufacturing, contract research organizations (CROs), and regulatory bodies. The 25 mg packaging is designed for precise analytical use in method development, validation, and routine quality testing.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Etodolac Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods to meet ICH Q2(R1) and other regulatory guidelines.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of related substances in Etodolac under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure Etodolac batches comply with pharmacopoeial standards (USP, EP, BP) and internal specifications.
• Regulatory Submissions and Compliance: Provides documented evidence of impurity characterization for Drug Master Files (DMFs), Common Technical Documents (CTD), and regulatory audits (FDA, EMA).
• Research into Metabolic Pathways: Can be utilized in preclinical and clinical studies to investigate the metabolism and pharmacokinetics of Etodolac.

Basic Information

Product Name	Etodolac Related Compound A (25 Mg) ((+/-)-8-Ethyl-1-Methyl-1,3,4,9-Tetrahydropyrano [3,4-B]-Indole-1-Acetic Acid)
CAS No.	109518-50-5
Molecular Formula	C17H21NO3
Molecular Weight	287.36 g/mol
Synonyms	(±)-8-Ethyl-1-methyl-1,3,4,9-tetrahydropyrano[3,4-b]indole-1-acetic acid; 1,3,4,9-Tetrahydropyrano[3,4-b]indole-1-acetic acid, 8-ethyl-1-methyl-, (±)-; Etodolac Impurity A; Etodolac Related Substance A; USP Etodolac Related Compound A; Etodolac EP Impurity A; (±)-8-Ethyl-1-methyl-1,2,3,4-tetrahydro-1H-pyrano[3,4-b]indole-1-acetic acid
EINECS	Contact for details

Quality Control

Every batch of Etodolac Related Compound A is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each unit, containing batch-specific data, analytical methods, and traceability information. Our quality commitment aligns with cGMP principles and supports compliance with major pharmacopoeias (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F). The product is light-sensitive and should be handled under appropriate conditions to maintain stability. Keep the container sealed in a dry environment to prevent moisture uptake.

Specification

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