Description

(+/-)-E-10-Hydroxylated-Nortriptyline Metabolite Maleate Salt CAS NO 37439-89-7 is a high-purity reference standard and key intermediate in pharmaceutical research and development. This compound is of significant value for its role in metabolic pathway studies and analytical method validation for tricyclic antidepressants. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in drug metabolism and pharmacokinetics (DMPK) research, bioanalytical testing, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the quantitative and qualitative analysis of nortriptyline and its metabolites in drug substances and finished products.
• Metabolite Research: Critical for in vitro and in vivo studies investigating the metabolic fate, activity, and toxicity of the parent drug nortriptyline.
• Bioanalytical Method Development: Serves as a key calibrator and quality control sample in developing and validating LC-MS/MS, HPLC, and other chromatographic methods for biological matrices.
• Impurity Identification and Control: Employed to identify, characterize, and quantify process-related impurities and degradation products in active pharmaceutical ingredient (API) manufacturing.
• Preclinical and Clinical Studies: Utilized in pharmacokinetic and pharmacodynamic studies to understand exposure-response relationships.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate understanding of a drug's metabolic profile.

Basic Information

Item	Details
Product Name	(+/-)-E-10-Hydroxylated-Nortriptyline Metabolite Maleate Salt
CAS No.	37439-89-7
Molecular Formula	C22H27NO6
Molecular Weight	401.46 g/mol
Synonyms	10-Hydroxynortriptyline Maleate Salt; E-10-Hydroxynortriptyline Maleate; (E)-10-Hydroxynortriptyline Maleate; trans-10-Hydroxynortriptyline Maleate; (±)-E-10-Hydroxynortriptyline Maleate; Nortriptyline Metabolite E Maleate; 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, (E)-, (2Z)-2-butenedioate (1:1)
EINECS	Contact for details

Quality Control

Our (+/-)-E-10-Hydroxylated-Nortriptyline Metabolite Maleate Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR), and residual solvent analysis, to ensure it meets stringent specifications for pharmaceutical research. Certificates of Analysis (COA) with detailed chromatographic data are provided for every 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 must be kept in a desiccated environment to maintain stability and purity.

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%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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