Description

Tazarotene Impurity 9 is a designated impurity standard of the active pharmaceutical ingredient Tazarotene. This compound is critical for ensuring the quality, safety, and efficacy of Tazarotene-based pharmaceutical formulations through rigorous analytical control. It is primarily required by pharmaceutical manufacturers and analytical laboratories for research, method development, and regulatory compliance purposes. The precise characterization of this impurity is essential for meeting stringent pharmacopeial standards in drug development and quality assurance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Tazarotene drug substance and drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and identification standard in the routine batch release testing of Tazarotene APIs and finished dosage forms.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (heat, light, humidity) during drug stability testing.
• Process Chemistry Research: Used by R&D scientists to understand and control the formation of this impurity during the synthesis and purification stages of Tazarotene manufacturing.

Basic Information

Product Name	Tazarotene Impurity 9
CAS No.	1332579-70-0
Molecular Formula	C21H21NO2S
Molecular Weight	351.46 g/mol
Synonyms	Ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate; Tazarotene Related Compound 9; Tazarotene EP Impurity I; Tazarotene USP Impurity; AGN 190299 Impurity 9; (6-Ethynyl-4,4-dimethylthiochroman-6-yl)-ethyl nicotinate; Impurity of Tazarotene
EINECS	Contact for details

Quality Control

Every batch of Tazarotene Impurity 9 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing including identification (IR, NMR), purity assay (HPLC), and control of related substances and residual solvents to ensure it meets the high standards required for pharmaceutical impurity analysis. A detailed Certificate of Analysis (COA) is provided with each lot, confirming compliance with specified analytical procedures. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 3.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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