Description

Trazodone Related Compound C is a high-purity chemical reference standard, identified by CAS No. 1263278-77-8. This compound is critically important for ensuring the quality, safety, and efficacy of the antidepressant drug Trazodone through rigorous analytical testing. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for use in method development, validation, and impurity profiling. Our supply guarantees the reliability and traceability essential for compliance in pharmaceutical development and production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Trazodone Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and GC methods to establish system suitability, specificity, and detection limits for impurity analysis.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing of Trazodone to ensure compliance with pharmacopeial monographs (USP, EP, BP).
• Regulatory Submissions: Provides essential data for drug master files (DMF), investigational new drug (IND) applications, and new drug applications (NDA).
• Stability Studies: Employed to monitor the formation of degradation products in Trazodone formulations under various stress conditions.
• Research & Development (R&D): Used in synthetic chemistry research to study the degradation pathways and metabolism of Trazodone.

Basic Information

Product Name	Trazodone Related Compound C
CAS No.	1263278-77-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Trazodone Impurity C; Trazodone Related Substance C; Trazodone Process Impurity; 2-[3-[4-(3-Chlorophenyl)piperazin-1-yl]propyl]-[1,2,4]triazolo[4,3-a]pyridin-3(2H)-one; UNII-9J97361D2P; Trazodone Chlorophenyl Piperazine Triazolopyridinone Derivative
EINECS	Contact for details

Quality Control

Every batch of Trazodone Related Compound C is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure compliance with pharmacopeial and internal specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

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