DONEPEZIL HYDROCHLORIDE

Donepezil Hydrochloride API is a reversible acetylcholinesterase inhibitor primarily used in the treatment of Alzheimer’s disease and other forms of dementia. It enhances cognitive function by increasing acetylcholine concentration in the brain, improving memory, alertness, and mental function in patients with neurodegenerative disorders.

At Bluepill Express, we are a WHO-GMP, ISO 9001:2015, and cGMP-certified manufacturer and global exporter of Donepezil Hydrochloride API. Our API is produced under stringent quality controls and conforms to IP, BP, and USP pharmacopeial standards. With exceptional purity, consistent particle size, and reliable stability, our Donepezil API ensures optimal performance in pharmaceutical formulations.

Donepezil Hydrochloride is widely used in oral solid dosage forms like tablets, capsules, and dispersible tablets. It is well-tolerated and suitable for long-term therapy under medical supervision.

Therapeutic Applications:

• Mild to moderate Alzheimer’s disease
• Vascular dementia
• Cognitive impairment associated with Parkinson’s disease
• Memory loss in elderly patients

Mechanism of Action:

Donepezil Hydrochloride acts by selectively inhibiting acetylcholinesterase, the enzyme responsible for breaking down acetylcholine, a key neurotransmitter in memory and cognition. By reducing acetylcholine degradation, Donepezil enhances cholinergic transmission in the brain, thereby improving memory, learning, and cognitive performance.

Technical Specifications:

• Chemical Name: (±)-2,3-Dihydro-5,6-dimethoxy-2-[(1-benzylpiperidin-4-yl)methyl]-1H-inden-1-one hydrochloride
• Molecular Formula: C₂₄H₂₉NO₃·HCl
• Molecular Weight: 415.96 g/mol
• CAS Number: 120011-70-3
• Description: White to off-white crystalline powder
• Assay (on dried basis): NLT 98.0% and NMT 102.0%
• Melting Point: 218°C – 222°C
• Solubility: Freely soluble in water and methanol; slightly soluble in ethanol and chloroform
• Storage Conditions: Store below 30°C, in a tightly closed, moisture-free container, protected from light

Pharmacological Classification:

• Therapeutic Class: Anti-Alzheimer’s, Cognitive Enhancer, Acetylcholinesterase Inhibitor
• Pharmacopoeial Standards: IP / BP / USP / EP
• Dosage Form Applications:
  • Tablets (5 mg, 10 mg)
  • Film-coated tablets
  • Orodispersible tablets
  • Combination formulations with NMDA receptor antagonists

Quality & Manufacturing – Bluepill Express Standards:

• Manufactured in WHO-GMP and ISO-certified plants
• High assay purity (≥99%) with consistent particle size
• Complies with USP/BP/IP monographs
• HPLC, IR, and UV-tested for identity and purity
• Full regulatory documentation: COA, MSDS, and DMF available
• Strict impurity profile control for enhanced formulation safety

Advantages of Bluepill Express Donepezil Hydrochloride API:

• Pharma-grade crystalline structure for uniform tablet compression
• Global compliance with USP/BP/IP specifications
• DMF-ready API suitable for regulated markets
• Batch consistency and stability for long-term supply contracts
• Flexible export packaging and documentation support

Packaging & Export Details:

• Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with inner LDPE liner
• Shelf Life: 3 years (under recommended conditions)
• Labeling: As per global pharmacopeial and export norms
• Export Markets: Europe, Asia-Pacific, Africa, Middle East, South America
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Drug Master File (DMF – on request)
  • Stability and regulatory compliance certificates