Zolpidem Tartrate API
Zolpidem Tartrate API is a pharmaceutical-grade active pharmaceutical ingredient (API) widely used in the manufacturing of medications indicated for the short-term management of insomnia. As a non-benzodiazepine hypnotic agent, it belongs to the imidazopyridine class and is valued for its rapid onset of action. Pharmaceutical manufacturers worldwide rely on high-purity Zolpidem Tartrate API to produce tablets and other oral dosage forms that meet international quality standards.
Product Information
Product Name: Zolpidem Tartrate API
Generic Name: Zolpidem Tartrate
CAS Number: 99294-93-6
Molecular Formula: C19H21N3O·C4H6O6
Molecular Weight: 764.87 g/mol (Tartrate Salt)
Dosage Forms: Tablets, Oral Formulations
Category: Sedative-Hypnotic Active Pharmaceutical Ingredient
Pharmaceutical Uses of Zolpidem Tartrate API
Zolpidem Tartrate API is used as the raw material for manufacturing pharmaceutical products intended for the short-term treatment of insomnia characterized by difficulty in falling asleep. Due to its rapid absorption and fast onset of action, it is commonly formulated into immediate-release and modified-release tablet formulations. Pharmaceutical companies procure high-quality API to ensure product consistency, efficacy, and compliance with pharmacopeial specifications.
Quality Standards and Manufacturing
The quality of an API directly influences the safety and performance of the finished pharmaceutical product. Pharmaceutical-grade Zolpidem Tartrate API is manufactured under stringent GMP-compliant conditions with advanced quality control systems. Every batch undergoes comprehensive analytical testing for identity, purity, assay, residual solvents, related substances, and microbiological quality before release.
Manufacturers also provide complete documentation, enabling smooth product registration and regulatory approvals across international markets.
Documentation Available
Global pharmaceutical buyers generally require comprehensive regulatory documentation, including:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Certificate of Origin (COO)
- Technical Data Sheet (TDS)
- Manufacturing Process Information
- Stability Data
- DMF/Regulatory Support (where available)
These documents help pharmaceutical manufacturers accelerate product development and international registrations.
Global Market Demand
Demand for Zolpidem Tartrate API continues across regulated and emerging pharmaceutical markets. Importers and formulation manufacturers in countries such as Brazil, Mexico, South Africa, Egypt, Vietnam, Indonesia, the Philippines, Thailand, Malaysia, Turkey, Saudi Arabia, and several European and Latin American markets procure this API for commercial pharmaceutical production. Consistent quality, regulatory compliance, and dependable supply remain key purchasing factors.
Why Choose Amber Lifesciences?
Amber Lifesciences supplies pharmaceutical-grade Zolpidem Tartrate API manufactured under robust quality management systems. The company focuses on consistent product quality, complete regulatory documentation, reliable export logistics, and timely deliveries to pharmaceutical manufacturers worldwide. With experienced technical support and an efficient global supply network, Amber Lifesciences helps customers source high-quality API raw materials for commercial pharmaceutical manufacturing.
Conclusion
Zolpidem Tartrate API is an important pharmaceutical raw material used in the production of medicines for short-term insomnia treatment. Selecting a reliable API manufacturer ensures product quality, regulatory compliance, and uninterrupted supply. Amber Lifesciences is committed to delivering high-quality Zolpidem Tartrate API backed by comprehensive documentation and dependable global export services, making it a trusted partner for pharmaceutical companies worldwide.
