Our Xenical Raw Material Powder (Orlistat API, CAS 96829-58-2) is manufactured under strict GMP conditions, delivering high purity, consistent quality, and stable bulk supply capability for global pharmaceutical manufacturers and supplement brands.
With proven expertise in API production and export, we provide a fully compliant, technically supported, and scalable supply solution for companies developing weight management formulations, fat-blocking supplements, and anti-obesity drug products. Whether you are a pharmaceutical manufacturer, contract producer, or ingredient distributor, our Orlistat raw material ensures reliable performance, regulatory support, and long-term supply stability.
Technical Specifications
|
Parameter |
Specification |
|
Product Name |
Orlistat (Xenical Raw Material) |
|
CAS Number |
96829-58-2 |
|
Molecular Formula |
C29H53NO5 |
|
Molecular Weight |
495.73 |
|
Appearance |
White to off-white powder |
|
Assay (HPLC) |
98.0% – 102.0% |
|
Impurity Profile |
Meets USP/EP standards |
|
Residual Solvents |
Complies with ICH Q3C |
|
Heavy Metals |
≤ 10 ppm |
|
Loss on Drying |
≤ 0.5% |
|
Identification |
IR / HPLC compliant |
|
Particle Size |
Customizable upon request |
|
Shelf Life |
24 months |
|
Storage |
Cool, dry, away from light |
Key Advantages
High Purity & Pharmaceutical Grade Quality
Our Orlistat raw material is produced using advanced synthesis and purification technology, ensuring high assay value and controlled impurity levels, suitable for regulated pharmaceutical formulations.
Strong Lipase Inhibition Performance
Orlistat acts as a potent gastrointestinal lipase inhibitor, reducing dietary fat absorption and supporting weight management product development.
GMP-Compliant Manufacturing System
Produced under strict GMP-controlled environments to ensure:
Batch-to-batch consistency
Full traceability
Regulatory compliance readiness
Stable Global Supply Capability
We support:
Small R&D quantities (10g–100g)
Pilot production scale
Industrial bulk supply (kg–ton level)
Full Documentation Support
Available documents include:
Certificate of Analysis (COA)
Material Safety Data Sheet (MSDS)
Stability Data
Regulatory support files (DMF available upon request)
Quality Assurance & Regulatory Compliance
We implement a strict quality management system covering:
Raw Material Control
Qualified upstream supplier screening
Incoming material verification
In-Process Quality Monitoring
Reaction control parameters
Intermediate purity testing
Final Product Testing
HPLC assay verification
Impurity profiling
Microbial limits testing
International Compliance Support
GMP manufacturing system
ISO-certified quality framework
USP / EP standard compliance capability
DMF documentation support (optional for regulatory filing)
