Description

Loperamide Impurity A CAS NO 1391052-94-0 is a high-purity reference standard used for the identification and quantification of a specific process-related impurity in Loperamide hydrochloride, an antidiarrheal medication. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and compliance with stringent regulatory guidelines. It is essential for quality control, method validation, and stability studies in the development and production of Loperamide API and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods in QC labs.
• Impurity Profiling and Identification: Used to identify, characterize, and quantify Loperamide Impurity A in active pharmaceutical ingredient (API) batches during stability and release testing.
• Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity analysis as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Compliance and Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA, EMA, and others to demonstrate control over impurities.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation and levels of this specific impurity over time.
• Research and Development: Used in R&D to study the synthesis pathway, degradation mechanisms, and to improve the purity of the final Loperamide API.

Basic Information

Product Name	Loperamide Impurity A
CAS No.	1391052-94-0
Molecular Formula	C29H33ClN2O2
Molecular Weight	477.04 g/mol
Synonyms	4-(4-Chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-piperidinebutyramide Impurity A; Loperamide Related Compound A; 1-Piperidinebutyramide, 4-(4-chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-, impurity A; Loperamide EP Impurity A; Loperamide Hydrochloride Impurity A
EINECS	Contact for details

Quality Control

Every batch of Loperamide Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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