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Loperamide Hydrochloride is a high-purity antidiarrheal Active Pharmaceutical Ingredient (API) widely used to control acute and chronic diarrhea and reduce stool frequency in patients with inflammatory bowel disease. It works by slowing intestinal motility and increasing absorption of water and electrolytes, providing rapid symptomatic relief.
Bluepill Express manufactures Loperamide Hydrochloride under WHO-GMP, ISO, and cGMP-certified facilities, ensuring exceptional purity, stability, and batch-to-batch consistency. The API is suitable for tablet, capsule, and oral suspension formulations, meeting international IP, BP, USP, and EP pharmacopoeial standards.
Therapeutic Classification
- Antidiarrheal
- Opioid receptor agonist (peripheral μ-opioid receptor)
- Gastrointestinal motility regulator
Mechanism of Action
Loperamide acts primarily on μ-opioid receptors in the gut wall, reducing peristaltic activity and prolonging transit time. This enhances water and electrolyte absorption, decreases stool frequency, and alleviates diarrhea without central nervous system effects at therapeutic doses.
Chemical & Composition Information
| Parameter | Details |
|---|---|
| Chemical Name | 4-(4-chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-piperidinebutanamide hydrochloride |
| Molecular Formula | C29H33ClN2O·HCl |
| Molecular Weight | 477.45 g/mol |
| CAS Number | 53179-11-6 |
| Form | Crystalline powder |
| Pharmacopoeial Standards | IP / BP / USP / EP |
| Therapeutic Class | Antidiarrheal, Peripheral Opioid Agonist |
Physical & Chemical Properties
- Appearance: White to off-white crystalline powder
- Solubility: Soluble in water and ethanol; slightly soluble in methanol
- Melting Point: 228–230°C
- Stability: Chemically stable under recommended storage conditions
Technical Specifications (Bluepill Express Standards)
| Parameter | Specification |
|---|---|
| Assay | 98.0% – 102.0% |
| Identification | IR, UV, and HPLC spectra match reference standard |
| Water Content (KF) | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Related Substances | ≤ 0.5% individual impurity, ≤ 1.0% total impurities |
| Bulk Density | 0.35 – 0.55 g/ml |
| Particle Size Distribution | D90 < 250 μm (customizable) |
| Heavy Metals | ≤ 10 ppm |
| Microbial Limits | Complies with pharmacopeial standards |
Pharmacological Applications
- Acute diarrhea management
- Chronic diarrhea associated with IBD or short bowel syndrome
- Reduces stool frequency and improves patient comfort
- Used in tablet, capsule, or liquid oral formulations
Dosage Forms
- Tablets: 2 mg, 4 mg
- Capsules: 2 mg, 4 mg
- Oral suspensions and solutions
Manufacturing Excellence – Bluepill Express
- WHO-GMP, ISO 9001:2015, and cGMP certified facilities
- Controlled crystallization for high purity and stability
- Batch-to-batch uniformity in particle size, moisture, and assay
- Complete regulatory documentation: COA, MSDS, TDS, DMF-ready dossiers
- Global export-ready API with competitive pricing
Packaging & Storage
- HDPE drums / fiber containers with PE liners
- Pack sizes: 5 kg / 10 kg / 25 kg
- Shelf Life: 36 months
- Storage: Store below 25°C, in a dry, cool environment, protected from light and moisture
Safety & Handling
- Handle with gloves, mask, and protective goggles
- Avoid inhalation, ingestion, or direct skin/eye contact
- Follow GMP and EHS guidelines for handling and disposal
