Description

Sulfadimethoxine Ep Impurity F is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the veterinary antibiotic Sulfadimethoxine. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Sulfadimethoxine Ep Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities in Sulfadimethoxine.
• Quality Control & Assurance (QC/QA): Serves as a critical tool in routine quality control testing to ensure API and drug product purity meets pharmacopeial (e.g., EP, USP) and internal specifications.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., CMC sections for FDA, EMA) by providing definitive proof of impurity identity and control during stability studies and batch release.
• Research & Development: Used in studies to understand the degradation pathways, stability profile, and formation mechanisms of impurities in Sulfadimethoxine formulations.
• Pharmacopeial Testing: Employed as a system suitability and identification standard for tests prescribed in the European Pharmacopoeia (EP) and other international compendia.

Basic Information

Product Name	Sulfadimethoxine Ep Impurity F
CAS No.	19868-00-9
Molecular Formula	C₁₂H₁₄N₄O₄S
Molecular Weight	310.33 g/mol
Synonyms	4-Amino-N-(2,6-dimethoxy-4-pyrimidinyl)benzenesulfonamide; Sulfadimethoxine Impurity F; Sulfadimethoxine Related Compound F; N1-(2,6-Dimethoxy-4-pyrimidinyl)sulfanilamide; Sulfanilamide, N1-(2,6-dimethoxy-4-pyrimidinyl)-; Sulfadimethoxine EP Impurity F
EINECS	Contact for details

Quality Control

Our Sulfadimethoxine Ep Impurity F is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with specified purity grades and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
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.