Description

Loperamide Hydrochloride CAS NO 34552-83-5 is a high-purity synthetic opioid receptor agonist primarily used for its potent antidiarrheal properties. This active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of finished pharmaceutical formulations. It is essential for manufacturers in the global pharmaceutical industry developing over-the-counter and prescription medications for gastrointestinal disorders.

Application

• Pharmaceutical API: Primary active ingredient in antidiarrheal medications, both OTC and prescription.
• Tablet Formulation: Used in the production of solid oral dosage forms for the treatment of acute and chronic diarrhea.
• Capsule Manufacturing: Incorporated into gelatin or vegetarian capsules for oral delivery.
• Pediatric Formulations: Utilized in the development of age-appropriate, lower-dose liquid or dissolvable medications.
• Veterinary Medicine: Applied in formulations for managing diarrhea in companion and livestock animals.
• Clinical Research: Serves as a reference standard and raw material in pharmacological studies and drug development programs.

Basic Information

Product Name	Loperamide Hydrochloride
CAS No.	34552-83-5
Molecular Formula	C29H33ClN2O2 • HCl
Molecular Weight	513.50 g/mol
Synonyms	Loperamide HCl; 4-(4-Chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-piperidinebutyramide Monohydrochloride; R-18553; Imodium (brand name); Loperamid Hydrochloride; Loperamidi Hydrochloridum; Loperamidum Hydrochloricum
EINECS	Contact for details

Quality Control

Our Loperamide Hydrochloride is manufactured under strict quality management systems. It undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identification, purity, and impurity profiles. Certificates of Analysis (COA) confirming compliance with relevant pharmacopeial standards (such as USP, EP, or BP) are provided with each batch.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%

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