Description

Mefloquine Ep Impurity C is a high-purity chemical reference standard, specifically identified as an impurity of the antimalarial drug Mefloquine. This compound is critical for pharmaceutical research and development, enabling the accurate identification, quantification, and control of related substances in active pharmaceutical ingredients (APIs) and finished drug products. It is an essential tool for quality control laboratories, analytical scientists, and regulatory affairs professionals in the pharmaceutical industry who require reliable reference materials to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as EP and USP.

Application

• Primary use as a certified reference standard for the analytical method development and validation of Mefloquine API.
• Critical component in impurity profiling and identification studies to meet ICH Q3A and Q3B guidelines.
• Used for quality control and batch release testing in pharmaceutical manufacturing to ensure specification compliance.
• Essential for stability studies to monitor the formation of degradation products over time.
• Serves as a calibration standard in high-performance liquid chromatography (HPLC) and other chromatographic systems.
• Supports regulatory submissions to agencies like the FDA and EMA by providing definitive impurity characterization data.
• Utilized in pharmacopeial testing to verify compliance with European Pharmacopoeia (EP) and other international monographs.
• Valuable for academic and contract research organizations (CROs) conducting research on antimalarial drugs and their metabolites.

Basic Information

Product Name	Mefloquine Ep Impurity C
CAS No.	51744-85-5
Molecular Formula	C17H16F6N2O
Molecular Weight	378.32 g/mol
Synonyms	(R*,S*)-(±)-α-2-Piperidinyl-2,8-bis(trifluoromethyl)-4-quinolinemethanol; Mefloquine Related Compound C; Mefloquine Impurity C; Mefloquine EP Impurity C; DL-Mefloquine impurity C; (±)-Mefloquine impurity C; RS-Mefloquine impurity C; 2,8-Bis(trifluoromethyl)-α-(2-piperidinyl)-4-quinolinemethanol
EINECS	Contact for details

Quality Control

Every batch of Mefloquine Ep 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 such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability. We support compliance with cGMP, ICH, and ISO guidelines for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F). The material should be kept in a cool, dry, and well-ventilated area. Avoid prolonged exposure to elevated temperatures, moisture, and direct light to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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