Description

Trimethoprim Ep Impurity I is a specified impurity used as a certified reference standard in the pharmaceutical quality control process. This compound is critical for ensuring the purity, safety, and efficacy of the antibacterial drug Trimethoprim, as mandated by pharmacopeial monographs. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing to comply with stringent EP, USP, and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a primary chemical reference material for the identification and quantification of Trimethoprim EP Impurity I in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Essential for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control and Batch Release: Used in routine QC testing to ensure Trimethoprim API and formulations meet the strict impurity limits set by pharmacopeias (EP, USP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of drug stability testing programs.
• Regulatory Compliance and Submissions: Critical for preparing regulatory documentation (e.g., CMC sections) to demonstrate control over the impurity profile for FDA, EMA, and other global health authority approvals.
• Research and Development: Utilized in pharmaceutical R&D to study the degradation pathways and chemistry of Trimethoprim, aiding in the development of more stable formulations.

Basic Information

Product Name	Trimethoprim Ep Impurity I
CAS No.	118791-61-0
Molecular Formula	C14H18N4O3
Molecular Weight	290.32 g/mol
Synonyms	5-[(3,4,5-Trimethoxyphenyl)methyl]-2,4-pyrimidinediamine 3-oxide; Trimethoprim Impurity I (EP); Trimethoprim N-Oxide; Trimethoprim Impurity F; 2,4-Diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine 1-oxide; 1-Oxide of Trimethoprim; TMP Impurity I; TMP N-Oxide
EINECS	Contact for details

Quality Control

Every batch of Trimethoprim Ep Impurity I (CAS 118791-61-0) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available for regulatory review.

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. For long-term storage, consider desiccated conditions.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.