Description

Trimethoprim Impurity A is a designated impurity reference standard used in the quality control of the antibiotic Trimethoprim. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical products by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Trimethoprim Impurity A in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Trimethoprim API meets pharmacopeial purity specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of this specific impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Compliance & Filings: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling.
• Research & Development: Utilized in synthetic chemistry research to study degradation pathways and to develop purification processes for Trimethoprim.

Basic Information

Product Name	Trimethoprim Impurity A
CAS No.	213745-86-9
Molecular Formula	C14H18N4O3
Molecular Weight	290.32 g/mol
Synonyms	2,4-Diamino-5-(3,4,5-trimethoxybenzyl)pyrimidin-3(4H)-one; 3,4,5-Trimethoxybenzylpyrimidine derivative; Trimethoprim N-Oxide Impurity; Trimethoprim Related Compound A; 5-[(3,4,5-Trimethoxyphenyl)methyl]-2,4-pyrimidinediamine 3-oxide
EINECS	Contact for details

Quality Control

Our Trimethoprim Impurity A is manufactured and handled under strict quality management systems. Each batch is subjected to rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance with ICH Q3A, Q3B, USP, and EP guidelines.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Total Impurities	≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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