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Amiloride Hydrochloride Dihydrate API is a potassium-sparing diuretic used in the management of hypertension, congestive heart failure (CHF), and edema associated with liver cirrhosis or nephrotic syndrome. It helps maintain potassium levels while promoting sodium and water excretion, making it an essential component in combination therapy with thiazide or loop diuretics.
At Bluepill Express, we are a WHO-GMP, ISO 9001:2015, and cGMP-certified manufacturer and exporter of Amiloride Hydrochloride Dihydrate Active Pharmaceutical Ingredient (API). Our API complies with IP, BP, and USP pharmacopeial standards and is manufactured using high-purity raw materials under strict quality control for consistent assay value, low impurities, and superior stability.
Amiloride Hydrochloride Dihydrate acts on the distal convoluted tubules of the nephron to inhibit sodium reabsorption, thereby reducing water retention and controlling blood pressure — without causing significant potassium loss. It is widely used in oral formulations such as tablets and capsules.
Therapeutic Applications:
- Hypertension (High Blood Pressure)
- Congestive Heart Failure (CHF)
- Edema due to liver cirrhosis or nephrotic syndrome
- Hypokalemia prevention in diuretic therapy
- Combination diuretic formulations with hydrochlorothiazide or furosemide
Mechanism of Action:
Amiloride Hydrochloride works by blocking epithelial sodium channels (ENaC) in the distal renal tubules. This action reduces sodium reabsorption and decreases potassium excretion, resulting in mild diuresis and maintenance of electrolyte balance. It helps prevent hypokalemia (potassium deficiency), which is common with other diuretics.
Technical Specifications:
- Chemical Name: 3,5-Diamino-6-chloro-N-(diaminomethylene)pyrazinecarboxamide monohydrochloride dihydrate
- Molecular Formula: C₆H₈ClN₇O·2H₂O
- Molecular Weight: 302.7 g/mol
- CAS Number: 17440-83-4
- Description: Yellow to pale yellow crystalline powder
- Assay (on dried basis): NLT 98.0% and NMT 102.0%
- Melting Point: 280°C – 290°C (with decomposition)
- Solubility: Freely soluble in water; slightly soluble in alcohol
- Storage Conditions: Store in a cool, dry place below 30°C, protected from light and moisture
Pharmacological Classification:
- Therapeutic Class: Potassium-Sparing Diuretic / Antihypertensive
- Pharmacopoeial Standards: IP / BP / USP / EP
- Dosage Form Applications:
- Tablets (5 mg, 10 mg)
- Combination tablets (Amiloride + Hydrochlorothiazide)
- Capsules and fixed-dose diuretic blends
Quality & Manufacturing – Bluepill Express Standards:
- Manufactured under WHO-GMP, ISO, and cGMP guidelines
- High assay purity (≥99%) and low impurity levels
- Validated analytical methods (HPLC/IR/UV) for consistency
- Batch-to-batch reproducibility and stability control
- Complies with global pharmacopeias (USP/BP/IP)
- DMF, COA, and MSDS available for all export consignments
- Manufactured using controlled temperature and humidity environments
Advantages of Bluepill Express Amiloride Hydrochloride Dihydrate API:
- High solubility and bioavailability for reliable formulations
- DMF-ready API for international registrations
- Consistent particle size distribution for smooth blending and compression
- Regulatory support documentation for global submissions
- Trusted by formulation companies across Asia, Africa, and Latin America
Packaging & Export Details:
- Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with double LDPE liner
- Shelf Life: 3 years under recommended storage conditions
- Labeling: As per international pharmacopeial and export norms
- Export Markets: Africa, Middle East, Asia-Pacific, Latin America, Europe
- Documentation Provided:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Drug Master File (DMF – on request)
- Stability and impurity data
