Description

Trimipramine Related Compound A (25 Mg) (Dehydro Trimipramine) is a high-purity analytical reference standard, specifically the dehydro derivative of the tricyclic antidepressant trimipramine. This compound is critical for ensuring the accuracy and reliability of pharmaceutical analysis, particularly in the identification and quantification of impurities and degradation products. It is an essential material for quality control laboratories in the pharmaceutical industry, research institutions, and regulatory bodies focused on method development, validation, and compliance testing for trimipramine-based drug substances and products.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the qualitative and quantitative analysis of trimipramine impurities in Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Method Development and Validation: Used as a critical standard to develop, optimize, and validate analytical methods, such as HPLC, UPLC, and GC-MS, for stability-indicating assays.
• Pharmacopoeial Compliance Testing: Supports testing to meet stringent purity requirements outlined in pharmacopoeias like USP, EP, and BP for trimipramine monographs.
• Stability and Forced Degradation Studies: Employed to identify and monitor degradation products formed under various stress conditions (e.g., light, heat, humidity) to establish product shelf-life.
• Quality Control and Batch Release: Essential for routine QC testing in pharmaceutical manufacturing to ensure batch-to-batch consistency and compliance with regulatory specifications.
• Research and Development: Used in metabolic and pharmacokinetic studies to understand the drug's behavior and to synthesize related compounds for biological evaluation.

Basic Information

Product Name	Trimipramine Related Compound A (25 Mg) (Dehydro Trimipramine)
CAS No.	315-69-5
Molecular Formula	C20H24N2
Molecular Weight	292.42 g/mol
Synonyms	Dehydrotrimipramine; 10,11-Dihydro-5H-dibenzo[b,f]azepine, 5-[3-(dimethylamino)-2-methylpropyl]-; 5-[3-(Dimethylamino)-2-methylpropyl]-10,11-dihydro-5H-dibenzo[b,f]azepine; Trimipramine Impurity A; Trimipramine EP Impurity A; Trimipramine Related Substance A; 2-Methyl-1-(10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)propan-1-amine
EINECS	206-254-7

Quality Control

Our Trimipramine Related Compound A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assay and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, analytical methods, and results is provided with every unit to support your regulatory and quality documentation.

Storage

Preserve in the original tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is light-sensitive (store away from light).

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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