Description

Loperamide Impurity A-D6 is a deuterium-labeled internal standard critical for ensuring the accuracy and reliability of analytical methods. This high-purity reference material is essential for pharmaceutical research and development, specifically in the quantification and control of impurities in Loperamide drug substances and products. It is primarily used by analytical chemists and quality control laboratories in the pharmaceutical industry to meet stringent regulatory requirements for method validation and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified internal standard for the precise quantification of Loperamide Impurity A in drug substances and finished products using LC-MS or GC-MS.
• Method Development and Validation: Critical for developing, validating, and transferring robust analytical methods in compliance with ICH Q2(R1) and other regulatory guidelines.
• Stability Indicating Studies: Used in forced degradation and long-term stability studies to track impurity profiles and ensure drug product safety over its shelf life.
• Quality Control & Batch Release: Enables accurate impurity profiling and specification testing for routine quality control of Loperamide API and formulations.
• Metabolite and Impurity Research: Aids in pharmacokinetic studies and the investigation of metabolic pathways by providing a stable isotopic tracer.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization and control data.

Basic Information

Product Name	Loperamide Impurity A-D6
CAS No.	1794737-31-7
Molecular Formula	C₂₉H₂₇D₆ClN₂O₂
Molecular Weight	Approx. 489.1 g/mol
Synonyms	4-(4-Chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-piperidinebutyramide-d6; Loperamide-d6 Related Compound A; Loperamide EP Impurity A-D6; Loperamide USP Impurity A-D6; Deuterated Loperamide Impurity A; Loperamide-d6 Impurity; 1-Piperidinebutyramide, 4-(4-chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-, deuterated
EINECS	Contact for details

Quality Control

Every batch of Loperamide Impurity A-D6 is manufactured under controlled conditions and undergoes rigorous analytical characterization to ensure identity, purity, and isotopic enrichment. Our quality assurance protocols are designed to support its use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, isotopic purity, and related substances by HPLC and/or LC-MS. We adhere to cGMP principles for the production of critical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (Mass Spectrometry)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
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.