Description

Indometacin Impurity 16 is a specified impurity of the non-steroidal anti-inflammatory drug (NSAID) Indomethacin, identified by the CAS registry number 99070-87-8. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily used by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical industry to ensure the purity, safety, and efficacy of Indomethacin API and its finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Indometacin Impurity 16 in active pharmaceutical ingredients (API) and drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurities in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Used in routine quality control laboratories to establish impurity profiles and ensure batch-to-batch consistency of Indomethacin.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and long-term stability studies.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., ANDA, NDA, CTA) to health authorities like the US FDA, EMA, and PMDA.
• Pharmacopoeial Testing: Supports testing to meet the monograph specifications of USP, EP, BP, or other international pharmacopoeias for Indomethacin.

Basic Information

Product Name	Indometacin Impurity 16
CAS No.	99070-87-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Indomethacin Impurity 16; 1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid impurity; Indomethacin Related Compound 16; 99070-87-8; Indometacin Related Substance 16; Indomethacin EP Impurity G; Potential degradation product of Indomethacin
EINECS	Contact for details

Quality Control

Our Indometacin Impurity 16 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support your regulatory needs.

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 product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment and handled under appropriate conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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