Loperamide Hydrochloride is a synthetic antidiarrheal pharmaceutical API belonging to the opioid receptor agonist class. It acts primarily on opioid receptors in the gastrointestinal tract to reduce intestinal motility and increase transit time, thereby helping reduce the frequency of loose stools.
Loperamide Hydrochloride has limited penetration into the central nervous system at therapeutic doses and is primarily used for the symptomatic treatment of acute and chronic diarrhea.
Loperamide Hydrochloride is a specialized gastrointestinal pharmaceutical API used in the manufacture of oral tablets, capsules and other solid dosage formulations.
Key quality attributes include identity, assay, related substances, water content, residue on ignition, heavy metals and residual solvents.
CAS Number: 34552-83-5
Molecular Formula: C29H34Cl2N2O2
Molecular Weight: 513.50 g/mol
Chemical Name: 4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-N,N-dimethyl-2,2-diphenylbutanamide hydrochloride
Synonym: Loperamide HCl
Drug Class: Opioid Receptor Agonist / Antidiarrheal
Therapeutic Class: Antidiarrheal Agent
Therapeutic Area: Gastroenterology
Molecule Type: Synthetic Small Molecule
Loperamide acts primarily on peripheral μ-opioid receptors in the intestinal wall.
Its activity:
These effects help control diarrhea while acting predominantly within the gastrointestinal tract.
Loperamide Hydrochloride API is used in formulations for:
Loperamide Hydrochloride may be incorporated into:
The API is particularly suitable for pharmaceutical products requiring rapid and effective symptomatic control of diarrhea.
Loperamide Hydrochloride is generally described as a white to off-white crystalline powder. It is practically insoluble in water and has greater solubility in selected organic solvents.
A controlled Loperamide Hydrochloride API manufacturing process may involve:
Typical Loperamide Hydrochloride API testing may include:
Store Loperamide Hydrochloride API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage conditions should follow validated stability data and the manufacturer's approved specification.
Loperamide Hydrochloride is relevant to research involving:
Loperamide Hydrochloride is a peripheral opioid receptor-active antidiarrheal API with CAS Number 34552-83-5, molecular formula C29H34Cl2N2O2, and molecular weight 513.50 g/mol. It reduces intestinal motility and prolongs gastrointestinal transit, supporting its use in the symptomatic treatment of diarrhea.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | Approximately 225°C – 230°C |