Description

Tramazoline Impurity A CAS NO 4751-46-6 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Tramazoline-based formulations.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying Tramazoline Impurity A in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Essential for developing and validating robust analytical methods, such as HPLC and GC, to monitor impurities during the drug manufacturing process.
• Quality Control and Batch Release Testing: Used as a primary standard in QC laboratories to ensure drug substance and product batches meet stringent purity specifications and regulatory requirements (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products in Tramazoline formulations under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate control over the impurity profile of the drug substance.
• Research and Development: Utilized in pharmaceutical R&D to study the synthesis pathways, degradation routes, and metabolic byproducts of Tramazoline.

Basic Information

Product Name	Tramazoline Impurity A
CAS No.	4751-46-6
Molecular Formula	C₁₃H₁₇N₃
Molecular Weight	215.30 g/mol
Synonyms	2-[(4,5-Dihydro-1H-imidazol-2-yl)methyl]-5,6,7,8-tetrahydroquinazoline; 2-[(4,5-Dihydro-1H-imidazol-2-yl)methyl]-5,6,7,8-tetrahydroquinazoline; Tramazoline Related Compound A; Tramazoline EP Impurity A; Tramazoline USP Impurity A; Tramazoline Process Impurity; Decongestant Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Tramazoline Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with each shipment to guarantee traceability and batch-to-batch consistency.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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