High-Quality Orlistat Raw Material Powder Supply

Orlistat 96829-58-2 is a gastrointestinal lipase inhibitor; common dosage forms include capsules and tablets. Combining the pharmacological effects of inhibiting dietary fat absorption, controlling body weight, and improving obesity-related metabolic abnormalities, it is the world's first approved oral anti-obesity drug and currently the only oral weight loss drug approved as an over-the-counter (OTC) drug in China.

Effects and Functions: It prevents about 30% of dietary fat from being absorbed through a unique "peripheral action" mechanism-inhibiting lipase activity in the gastrointestinal tract, thereby reducing calorie intake. It is suitable for obese and overweight patients who have undergone moderate dietary control and exercise, including weight loss treatment for patients with obesity-related comorbidities (such as type 2 diabetes, hypertension, dyslipidemia, etc.). Orlistat is a long-acting, specific gastrointestinal lipase inhibitor that acts only locally in the lumen of the stomach and small intestine. It forms a covalent bond with the active site serine of gastric lipase and pancreatic lipase, inactivating the lipase; inactivated enzymes cannot hydrolyze dietary triglycerides into absorbable free fatty acids and monoacylglycerols. Unhydrolyzed fat cannot be absorbed by the intestinal tract and is directly excreted out of the body with feces. The standard 120mg dose can block about 30% of dietary fat absorption, creating a calorie gap to achieve weight management.

As the preferred weight loss API raw material at home and abroad, Orlistat is a mature gastrointestinal lipase inhibitor with a clear mechanism of action, sufficient clinical data, and long-term verified safety. The raw material supply is stable, meets preparation production needs, is widely used in domestic and foreign weight loss drug development, and is the core raw material favored by global weight loss preparation manufacturers.

1.It belongs to specific gastrointestinal lipase inhibitors, acting only locally in the intestine, almost not entering the bloodstream.

2.Principle of action: Binds with gastric lipase and pancreatic lipase to inactivate them, blocking about 30% of dietary fat absorption.

3.It does not act on the central nervous system and has no appetite-suppressing effect; it only blocks the absorption of dietary fat, without affecting the absorption of carbohydrates.

4.API purity can reach 99.0%~99.5%, meeting CP, USP, and EP multi-country pharmacopoeia testing standards.

5.Preferred raw material for weight loss preparations at home and abroad, with a long clinical application time, complete data, and high market recognition.

6.Mainly used to produce Orlistat weight loss capsules, domestic as OTC drugs, overseas available in 60mg and 120mg specifications.

1.Orlistat API raw material is mainly used to produce adult weight loss capsule preparations, being the core API raw material for weight loss drugs.

2.Can be used to develop domestic OTC Orlistat capsule products according to Chinese Pharmacopoeia (CP) standards.

3.Can be used to develop weight loss preparations exported overseas according to USP and EP pharmacopoeia standards.

4.Suitable for 120mg specification Orlistat hard capsule production, meeting prescription and OTC market needs.

5.Can be used for R&D and batch production of overseas 60mg low-dose Orlistat weight loss preparations.

6.Used for R&D and commercial production of weight management drugs for obese and overweight populations.

7.Used by pharmaceutical R&D institutions to conduct Orlistat-related preparation formulation and stability research.

8.Available for pharmaceutical companies for generic drug applications, supporting domestic and foreign drug registration projects.

1.HPLC High-Performance Liquid Chromatography: Main content determination, external standard method to calculate Orlistat purity, simultaneously testing each known single impurity and total impurities.
2.IR Infrared Spectroscopy: Used for raw material identification, comparing the sample infrared spectrum with the standard spectrum to confirm Orlistat molecular structure.
3.Specific Optical Rotation Determination: Detected using a polarimeter to control chiral purity, being a key chiral indicator for Orlistat API.
4.Karl Fischer Water Content Determination: Tests raw material water content, controlling moisture to prevent degradation during storage.
5.Residue on Ignition Test: Weighing residue after high-temperature ignition to determine inorganic residue, reflecting inorganic salt impurity levels.
6.Heavy Metals Testing: Adopting atomic absorption or ICP methods to test heavy metal residues such as lead, arsenic, cadmium, and mercury.
7.Melting Point Testing: Using a melting point apparatus to determine the melting range, assisting in judging raw material crystal form and purity.
8.Microbial Limit Test: Testing total aerobic microbial count, molds, yeasts, and controlled bacteria to meet API microbial quality control requirements.

1.High raw material purity; HPLC content can reach 99.0%~99.5%, complying with CP, USP, EP multi-country pharmacopoeia quality standards.

2.Strict quality control system, full-item testing for each factory batch, full set of quality inspection documents such as COA, MSDS, spectra provided, facilitating domestic and foreign preparation applications.

3.Mature and stable technology, controllable chiral purity, stable crystal form, small batch-to-batch variation, adapting to capsule preparation production.

4.Sufficient inventory, flexibly supporting lab-scale samples, kilogram-level sampling, and ton-level bulk orders, with continuous and stable supply.

5.Rich import and export experience, familiar with domestic and foreign API export procedures, complete supporting clearance documents, supporting global shipping.

6.Price possesses market competitiveness, source direct supply mode, saving intermediate links, long-term large orders negotiable for discounts.

7.Professional technical team support, providing formulation reference, storage and usage technical guidance, and quickly responding to customer technical questions.

8.Rigorous compliance management, strictly managed per pharmaceutical API, used only for pharmaceutical preparations, providing compliant export solutions to avoid regulatory risks.

I. Packaging Methods
1.Inner Packaging: Aluminum foil vacuum bag, light-proof, moisture-proof, isolating air; 1 kg/bag, sample commonly 10g, 50g, 100g small aluminum foil bags.
2.Outer Packaging: Fiber drum, lined with aluminum foil bags. Regular specifications: 5 kg/drum, 25 kg/drum.
3.Drum Body Labeling: Product name, CAS No., batch number, net weight, gross weight, production date, expiry date, storage conditions.
4.Custom Service: Neutral packaging or customer private label packaging can be done according to customer requirements (communication in advance required).
5.Sealing Inspection: Each bag vacuum sealed, leak check before leaving factory to prevent moisture and oxidation during transportation.

II. Logistics Key Points
1.Storage Requirements: Product needs 2–8℃ refrigeration, high temperature causes melting, degradation, full process avoiding exposure to strong sun.
2.Transportation Methods:
◇ Samples: International express (DHL/FedEx/UPS), paired with insulated ice packs + insulated box;
◇ Bulk Goods: Sea freight / Air freight, priority for cold chain containers.
3.Temperature Control Solution: Insulated box + ice packs for short-distance; cold chain recommended for long-distance bulk goods, avoiding long-term retention in high-temperature areas.
4.Documents & Materials: COA, MSDS, commercial invoice, packing list attached with goods to meet import and export clearance.
5.Transportation Taboos: Cannot be mixed with strong oxidants, strong acids, and strong alkalis; keep away from heat sources.
6.Delivery Lead Time: Samples arranged to be sent out within 1–3 days; bulk goods delivery time negotiated in advance.
7.Destination: Global shipping available; customers are responsible for destination country drug access and compliance.

1.Provide tracking number information promptly after order shipment, full tracking of goods logistics dynamics, and synchronizing transport status.
2.Support checking goods packaging, batch number, and quantity after the customer receives the goods, assisting in handling arrival damage and leakage issues.
3.Provide a full set of quality inspection documents with goods; provide technical Q&A for COA test indicators after receiving samples / bulk goods.
4.Support customer laboratory testing; if questions arise during inspection, our side cooperates to re-check batch data and provide spectrum evidence.
5.Provide technical guidance related to product storage, transfer, feeding usage, including temperature control and operation precautions.
6.Long-term customers can be continuously supplied with stable batches of the same process, synchronizing process and quality standard change information in advance.
7.Quickly respond to customer inquiries, reply to product, document, and export-related questions in time on working days with efficient communication.
8.Strictly comply with after-sales requirements, providing only API raw material technical services, not promising preparation efficacy; customers must comply with target country regulations.

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