Description

Loperamide Ep Impurity E is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Loperamide. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification and quantification of this specific impurity during manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams focused on compliance with pharmacopeial monographs.

Application

• Primary use as a certified reference standard (CRS) for analytical method development and validation.
• Identification and quantification of Loperamide Ep Impurity E in pharmaceutical quality control (QC) testing.
• Impurity profiling and characterization studies in pharmaceutical research and development (R&D).
• Calibration of analytical instruments (e.g., HPLC, UPLC, LC-MS) for regulatory compliance testing.
• Preparation of in-house working standards for batch release testing of Loperamide API and finished dosage forms.
• Supporting regulatory submissions (e.g., ANDA, NDA) by providing impurity data to agencies like the FDA and EMA.

Basic Information

Product Name	Loperamide Ep Impurity E
CAS No.	1426322-82-8
Molecular Formula	C29H33ClN2O2
Molecular Weight	477.04 g/mol
Synonyms	Loperamide Impurity E; Loperamide Related Compound E; 4-(4-Chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-piperidinebutyramide Impurity E; 1-Piperidinebutanamide, 4-(4-chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-, impurity E; Loperamide EP Impurity E; Loperamide USP Impurity E; Loperamide Hydrochloride Impurity E
EINECS	Contact for details

Quality Control

Every batch of Loperamide Ep Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards (EP, USP) and customer-specific requirements. Comprehensive Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided to guarantee traceability and reliability for your critical applications.

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 in a dry environment 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 impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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