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Product Specifications
Complete technical specifications and quality parameters for Mefloquine Tablets USP 250mg by Taj Pharma.
Product Identity
| Generic Name | Mefloquine Hydrochloride USP |
|---|---|
| Brand Name | Mefloquin |
| Manufacturer | Taj Pharmaceuticals Ltd. |
| Strength | 250mg (equivalent to mefloquine 250mg) |
| Dosage Form | Tablet, Film-coated |
| Route of Administration | Oral |
Composition & Ingredients
Active Ingredient
| Ingredient | Strength per Tablet | Potency |
|---|---|---|
| Mefloquine Hydrochloride USP | 274 mg | Equivalent to Mefloquine 250mg |
Excipients (Inactive Ingredients)
Lactose Monohydrate
Filler and binder
Croscarmellose Sodium
Disintegrant
Magnesium Stearate
Lubricant
Microcrystalline Cellulose
Filler
Sodium Starch Glycolate
Disintegrant
Film Coating Agents
Appearance and protection
Physical Properties
Appearance
White to off-white, round, film-coated tablet
Dimensions
Approximately 12mm diameter, 4mm thickness
Weight
Average tablet weight: 400-450mg
Solubility
Sparingly soluble in water, soluble in alcohol
Shelf Life & Storage Conditions
Shelf Life
Standard Shelf Life: 36 months from date of manufacture
Storage Conditions: Store below 30°C (86°F)
Humidity: Protect from moisture and humidity
Light: Store in original container, protect from light
Recommended Storage
- Store in a cool, dry place
- Keep container tightly closed
- Protect from moisture and humidity
- Do not store in bathroom
- Keep away from direct sunlight
- Do not freeze
Quality Parameters
| Parameter | Specification | Test Method |
|---|---|---|
| Assay (Content) | 95.0% - 105.0% of labeled amount | HPLC |
| Dissolution | Not less than 75% in 30 minutes | USP Apparatus 2 |
| Hardness | 5-10 kp | Monsanto Hardness Tester |
| Friability | Not more than 1% weight loss | Roche Friabilator |
| Thickness | 3.5 - 4.5 mm | Vernier Caliper |
| Weight Variation | Within USP limits | Analytical Balance |
Regulatory Status
Regulatory Approvals
- US FDA: Approved (ANDA)
- EMA: Approved
- WHO Prequalification: Listed
- Multiple National Authorities: Approved
Quality Certifications
- WHO-GMP Certified Manufacturing Facility
- ISO 9001:2015 Quality Management
- ISO 14001:2015 Environmental Management
- OHSAS 18001:2007 Occupational Health
BCS Classification
Biopharmaceutics Classification
BCS Class: Class II (Low solubility, High permeability)
Solubility: Poorly water soluble
Permeability: High permeability
Implications: Dissolution rate-limited absorption
Formulation Strategy: Optimized for enhanced dissolution