Description

Trimethoprim Impurity C is a specified impurity used as a critical reference standard in the analytical profiling of the antibiotic Trimethoprim. This compound is essential for pharmaceutical quality control, enabling precise identification and quantification of related substances to ensure drug safety and efficacy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Trimethoprim Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurities in Trimethoprim synthesis and formulation.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure analytical procedures remain accurate and precise.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs), ANDAs, and INDs.
• Stability Studies: Employed to track the formation of degradation products in Trimethoprim under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in pharmaceutical R&D to study impurity formation pathways and to optimize synthetic processes for higher purity.

Basic Information

Product Name	Trimethoprim Impurity C
CAS No.	29606-06-2
Molecular Formula	C14H18N4O3
Molecular Weight	290.32 g/mol
Synonyms	2,4-Diamino-5-(3,4,5-trimethoxybenzyl)pyrimidin-3(2H)-one; 3-Desoxytrimethoprim; Trimethoprim Impurity 3; Trimethoprim EP Impurity C; Trimethoprim Related Compound C; 5-[(3,4,5-Trimethoxyphenyl)methyl]-2,4-pyrimidinediamine 3-oxide (incorrect tautomer); TMP Impurity C
EINECS	Contact for details

Quality Control

Every batch of Trimethoprim Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC-MS, NMR) to ensure compliance with pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions 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%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.