Description

Trimethoprim Related Compound A (25 Mg) (4-Amino-5-(3,4,5-Trimethoxybenzyl)Pyrimidin-2-Ol) (As) is a high-purity analytical reference standard, essential for pharmaceutical research and quality control. This compound serves as a critical impurity marker for the validation of analytical methods used in the production and testing of the antibiotic Trimethoprim. It is primarily required by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and contract research organization (CRO) sectors to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Trimethoprim active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: A critical component for developing, validating, and verifying High-Performance Liquid Chromatography (HPLC) and other chromatographic methods according to ICH Q2(R1) guidelines.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity levels against strict pharmacopeial limits (e.g., USP, EP, BP) to ensure batch-to-batch consistency and safety.
• Stability Studies: Used to track the formation of this related compound during forced degradation and long-term stability studies of Trimethoprim formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports synthetic chemistry research focused on Trimethoprim analogs and studies on the degradation pathways of pyrimidine derivatives.

Basic Information

Product Name	Trimethoprim Related Compound A (25 Mg) (4-Amino-5-(3,4,5-Trimethoxybenzyl)Pyrimidin-2-Ol) (As)
CAS No.	60729-91-1
Molecular Formula	C14H17N3O4
Molecular Weight	291.30 g/mol
Synonyms	4-Amino-5-(3,4,5-trimethoxybenzyl)pyrimidin-2-ol; Trimethoprim Impurity A; Trimethoprim Related Substance A; 2-Pyrimidinol, 4-amino-5-[(3,4,5-trimethoxyphenyl)methyl]-; TMP Impurity A; TMP Related Compound A; 4-Amino-5-(3,4,5-trimethoxybenzyl)-2-pyrimidinol
EINECS	Contact for details

Quality Control

Our Trimethoprim Related Compound A is manufactured and handled under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the high standards required for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for purity, assay, and impurity profiles. Our quality commitment aligns with the needs of cGMP and ISO 17025-accredited laboratories.

Storage

Preserve in the original tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F). Keep the container in a dry, cool, and well-ventilated area. Handle with appropriate laboratory safety practices to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Assay (on dried basis)	97.0% - 103.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual unknown: ≤ 0.10% Total impurities: ≤ 2.0%

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