| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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| product name | Donepezil HCl |
| CAS NO. | 120011-70-3 |
| Specification | 99% |
| Appearance | white powder |
| Package | 1KG/Bag,25Kg/drum |
| MOQ | 1kg |
Donepezil hydrochloride, drug name, is suitable for the treatment of mild or moderate Alzheimer's dementia symptoms.
Donepezil hydrochloride is a long-acting symptomatic treatment for Alzheimer's disease (AD). AD is an acquired intellectual impairment characterized by memory loss and other cognitive impairments. Research in the past 30 years has shown that the progressive degeneration of cholinergic neurons in AD is the cause of memory loss, disorientation, behavioral and personality changes. This cholinergic theory has been confirmed by histological studies. Donepezil hydrochloride is a second-generation cholinesterase (ChE) inhibitor. Its therapeutic effect is to reversibly inhibit the hydrolysis of acetylcholinesterase (AchE) caused by acetylcholine and increase the content of acetylcholine at the receptor site. Donepezil may have other mechanisms, including the disposal of peptides, direct effects on neurotransmitter receptors or Ca2+ channels.
| Items | Standards | Results |
| Physical Analysis | ||
| Appearance | white powder | Complies |
| Specification | 99% | Complies |
| Mesh Size | 100 % pass 80 mesh | Complies |
| Ash | ≤ 5.0% | 2.85% |
| Loss on Drying | ≤ 5.0% | 2.85% |
| Chemical Analysis | ||
| Heavy Metal | ≤ 10.0 mg/kg | Complies |
| Pb | ≤ 2.0 mg/kg | Complies |
| As | ≤ 1.0 mg/kg | Complies |
| Hg | ≤ 0.1 mg/kg | Complies |
| Microbiological Analysis | ||
| Total Plate Count | ≤ 1000cfu/g | Complies |
| Yeast&Mold | ≤ 100cfu/g | Complies |
| E.coil | Negative | Negative |
| Salmonella | Negative | Negative |
| Conclusion: in conformity with the enterprise standard | ||
[Indications] Treatment of mild or moderate Alzheimer's dementia symptoms.
[Usage and Dosage]
1. Adults/elderly: Initial treatment dose 5 mg/day (once a day). This product should be taken orally at night before going to bed. The dose of 5 mg/day should be maintained for at least one month to evaluate early clinical responses and achieve steady-state blood concentrations of donepezil hydrochloride. After one month of treatment with 5 mg/day and clinical evaluation, the dose of this product can be increased to 10 mg/day (once a day). The recommended maximum dose is 10 mg. No clinical trials have been conducted with doses greater than 10 mg/day. No clinical trials have been conducted for more than 6 months compared with placebo. After stopping treatment, the efficacy of this product gradually decreases. There is no rebound phenomenon when treatment is stopped.
2. Hepatic and renal impairment: The elimination of donepezil hydrochloride is not affected in patients with renal and mild to moderate hepatic impairment, so similar dosage regimens can be used in these patients.
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