Description

Trimethoprim Related Compound B (25 Mg) (2,4-Diaminopyrimidin-5-Yl)(3,4,5-Trimethoxyphenyl)Methanone) (As) is a high-purity analytical reference standard, chemically defined as a key structural analog of the antibiotic Trimethoprim. This compound is essential for pharmaceutical research and development, serving as a critical impurity marker for quality control and method validation in drug manufacturing. It is primarily utilized by analytical chemists, quality assurance laboratories, and R&D departments within the pharmaceutical and fine chemical industries to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material (CRM) for the identification and quantification of related substances in Trimethoprim active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in compliance with ICH Q2(R1) and USP guidelines.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies to monitor the formation of degradation products.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Quality Control (QC) Testing: Acts as a system suitability standard and a quantifiable impurity in routine QC release testing of Trimethoprim batches.
• Academic and Industrial Research: Used in chemical and pharmacological research to study the structure-activity relationships (SAR) of diaminopyrimidine derivatives.

Basic Information

Product Name	Trimethoprim Related Compound B (25 Mg) (2,4-Diaminopyrimidin-5-Yl)(3,4,5-Trimethoxyphenyl)Methanone) (As)
CAS No.	30806-86-1
Molecular Formula	C16H18N4O4
Molecular Weight	330.34 g/mol
Synonyms	Trimethoprim Impurity B; Trimethoprim Related Substance B; (2,4-Diamino-5-pyrimidinyl)(3,4,5-trimethoxyphenyl)methanone; 5-[(3,4,5-Trimethoxybenzoyl)methyl]-2,4-pyrimidinediamine; Methanone, (2,4-diamino-5-pyrimidinyl)(3,4,5-trimethoxyphenyl)-; Trimethoprim EP Impurity B; Trimethoprim USP Related Compound B
EINECS	Contact for details

Quality Control

This analytical standard is manufactured and controlled under a strict quality management system. Each batch is subjected to comprehensive testing, including identity confirmation by IR and HPLC, high-purity assay (typically ≥95% by HPLC), and specific impurity profiling. A detailed Certificate of Analysis (COA) is supplied with each unit, providing batch-specific data on purity, related substances, and residual solvents. Our quality protocols are designed to meet the exacting requirements of pharmacopeial standards (USP, EP) for reference materials.

Storage

Preserve in the original, tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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