Description

Trimethoprim Impurity 3 is a designated reference standard used for the analytical profiling and quality control of the antibiotic Trimethoprim. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily used in research and development, method validation, and as a critical component in impurity identification studies for Trimethoprim API and its formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Trimethoprim Impurity 3 in active pharmaceutical ingredient (API) batches.
• Method Development and Validation: Essential for developing and validating analytical methods, particularly HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Trimethoprim drug substances and products meet pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation of this specific impurity during forced degradation and long-term stability studies of Trimethoprim.
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for safety and quality assessments.
• Research and Development: Utilized in synthetic chemistry research to understand degradation pathways and to improve purification processes for Trimethoprim.

Basic Information

Product Name	Trimethoprim Impurity 3
CAS No.	72920-13-9
Molecular Formula	C14H18N4O3
Molecular Weight	290.32 g/mol
Synonyms	2,4-Diamino-5-(3,4,5-trimethoxybenzyl)pyrimidin-3(4H)-one; 1-(3,4,5-Trimethoxybenzyl)-2,4-diamino-6-hydroxypyrimidine; Trimethoprim Impurity C; Trimethoprim Related Compound C; 5-[(3,4,5-Trimethoxyphenyl)methyl]-2,4-pyrimidinediamine-3-oxide
EINECS	Contact for details

Quality Control

Our Trimethoprim Impurity 3 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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