Description

Tropicamide EP Impurity A Dihydrochloride (Tropicamide USP Related Compound A Dihydrochloride) is a high-purity reference standard and impurity used in pharmaceutical quality control. This compound is critical for ensuring the safety and efficacy of Tropicamide drug products by enabling accurate identification and quantification of this specific impurity during analysis. It is an essential material for analytical laboratories, quality assurance departments, and research institutions within the pharmaceutical industry that are involved in method development, validation, and regulatory compliance for ophthalmic solutions.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Tropicamide EP Impurity A / USP Related Compound A in drug substances and finished products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or other chromatographic methods to monitor impurities in Tropicamide.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Tropicamide API and formulations meet stringent pharmacopeial specifications (USP, EP, JP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (light, heat, humidity) as part of drug stability profiling.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research on Degradation Pathways: Used in investigative studies to understand the chemical degradation mechanisms of Tropicamide.

Basic Information

Product Name	Tropicamide EP Impurity A Dihydrochloride
CAS No.	57786-23-9
Molecular Formula	C17H21Cl2N3O2
Molecular Weight	370.27 g/mol
Synonyms	Tropicamide USP Related Compound A Dihydrochloride; Tropicamide Impurity A Dihydrochloride; N-Ethyl-2-phenyl-N-(pyridin-4-ylmethyl)acetamide Dihydrochloride; Tropicamide Related Substance A Dihydrochloride; Tropicamide EP Impurity A; Tropicamide Degradant; 4-Pyridinemethanamine, N-ethyl-N-(2-phenylacetyl)-, dihydrochloride
EINECS	Contact for details

Quality Control

Every batch of Tropicamide EP Impurity A Dihydrochloride is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing to ensure identity, purity, and strength conform to high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results from tests including identification (IR, HPLC), assay (HPLC), related substances, residual solvents, and water content. Our quality commitment supports compliance with USP, EP, and ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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