Rivastigmine Hydrogen Tartrate is a potent cholinesterase inhibitor used in the treatment of mild to moderate Alzheimer’s disease and Parkinson’s disease dementia. It enhances cognitive function by increasing the concentration of acetylcholine, a neurotransmitter essential for memory and thinking processes.
At Bluepill Express, we manufacture and export Rivastigmine Hydrogen Tartrate API that meets WHO-GMP, ISO 9001:2015, and cGMP quality standards. Our API exhibits high purity (≥99%), excellent stability, and low impurity profile, ensuring consistent results in finished formulations.
Rivastigmine Hydrogen Tartrate is extensively used in oral capsules, oral solutions, and transdermal patches. It offers prolonged action and better tolerability, making it a preferred API in global cognitive health formulations.
Therapeutic Applications:
- Alzheimer’s disease (mild to moderate dementia)
- Parkinson’s disease dementia
- Cognitive decline and memory impairment management
Mechanism of Action:
Rivastigmine inhibits both acetylcholinesterase and butyrylcholinesterase, leading to an increase in acetylcholine levels in the synaptic cleft. This enhances cholinergic neurotransmission, which supports memory and learning functions, especially in Alzheimer’s patients.
Technical Specifications:
- Chemical Name: (S)-3-[1-(Dimethylamino)ethyl]phenyl ethyl(methyl)carbamate hydrogen tartrate
- Molecular Formula: C₁₄H₂₂N₂O₂·C₄H₆O₆
- Molecular Weight: 400.42 g/mol
- CAS Number: 129101-54-8
- Appearance: White to off-white crystalline powder
- Assay (on dried basis): NLT 98.0% and NMT 102.0%
- Solubility: Freely soluble in water and methanol
- Storage Conditions: Store below 25°C, protected from moisture and light
Pharmacological Classification:
- Therapeutic Class: Cholinesterase inhibitor / Anti-dementia agent
- Pharmacopoeial Standards: IP / BP / USP / EP
- Dosage Form Applications:
- Oral capsules (1.5 mg, 3 mg, 4.5 mg, 6 mg)
- Oral solutions and suspensions
- Transdermal patch formulations
Manufacturing & Quality Standards – Bluepill Express:
- Manufactured under WHO-GMP, ISO 9001:2015, and cGMP compliant facilities
- High assay (≥99%) ensuring consistent potency
- Analytical testing by HPLC, NMR, and FTIR for identity and purity
- Low impurity and solvent levels per ICH guidelines
- COA, MSDS, and DMF documentation available for global registration
- Batch-to-batch consistency with validated manufacturing processes
Advantages of Bluepill Express Rivastigmine Hydrogen Tartrate API:
- High-purity API with superior stability
- DMF-ready documentation for regulated markets
- Controlled particle size for formulation flexibility
- Complies with international pharmacopeial standards (IP/BP/USP/EP)
- Proven stability data for long-term storage
Packaging & Export Details:
- Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with double LDPE liners
- Shelf Life: 3 years under recommended storage conditions
- Labeling: As per international export and pharmacopeial guidelines
- Export Markets: Europe, Middle East, Latin America, Africa, and Southeast Asia
- Documentation Provided:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Drug Master File (DMF – available upon request)
- Stability & validation data
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