Description

Loperamide Ep Impurity G CAS NO 109572-89-6 is a high-purity chemical reference standard, specifically identified as a known impurity of the active pharmaceutical ingredient Loperamide Hydrochloride. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by enabling accurate identification and quantification during analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and quality control in compliance with pharmacopeial standards like the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analysis of Loperamide Hydrochloride drug substance and finished dosage forms.
• Method Development and Validation: Used in developing and validating analytical methods, particularly HPLC and UPLC, to monitor impurity profiles.
• Quality Control (QC) Testing: Essential for routine QC testing in pharmaceutical manufacturing to ensure batches meet specified impurity limits.
• Stability Studies: Employed to track the formation of degradation impurities in Loperamide formulations under various storage conditions.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data.
• Research and Development: Utilized in R&D for studying the degradation pathways and chemistry of Loperamide.

Basic Information

Product Name	Loperamide Ep Impurity G
CAS No.	109572-89-6
Molecular Formula	C29H33ClN2O2
Molecular Weight	477.04 g/mol
Synonyms	Loperamide Impurity G; Loperamide Related Compound G; 4-(4-Chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-piperidinebutyramide Impurity G; 1-[3-(Dimethylamino)-3-oxo-2,2-diphenylpropyl]-4-(4-chlorophenyl)-4-hydroxypiperidinium; Loperamide EP Impurity G
EINECS	Contact for details

Quality Control

Every batch of Loperamide Ep Impurity G is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile.

Storage

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

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 guidelines

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