Explore our cGMP manufactured API catalog and custom peptide solutions available for global export
A comprehensive analysis of molecular structure, enzymatic kinetics, purity profiles, and quality compliance standards for pharmaceutical formulation
| Property / Characteristic | Specification Target Standard | Analytical Test Method |
|---|---|---|
| Chemical Name (IUPAC) | (2S)-1-[[(2S,3S)-3-hexyl-4-oxooxetan-2-yl]methyl]dodecyl (2S)-2-formamido-4-methylpentanoate | Structure Validated via NMR & MS |
| CAS Registry Number | 96829-58-2 | Reagent Database Reference |
| Molecular Formula & Weight | C29H53NO5 | 495.73 g/mol | High-Resolution Mass Spectrometry (HRMS) |
| API Purity / Assay (HPLC) | 99.0% – 101.0% (On Anhydrous Basis) | Validated RP-HPLC vs USP Standard |
| Impurity Profile (Single Largest) | ≤ 0.10% (Impurity A/B/C USP Specification) | HPLC-UV (210 nm) Chiral Analysis |
| Melting Point Range | 43.0°C to 45.0°C | Capillary Melting / Differential Scanning Calorimetry (DSC) |
| Specific Optical Rotation [α]D20 | -32.0° to -35.0° (c=1 in methanol) | Polarimetry |
| Residual Solvents | Meets ICH Q3C Requirements (Acetone <500ppm, Hexane <290ppm) | Headspace Gas Chromatography (HS-GC-FID) |
| Heavy Metals & Ash | Heavy Metals ≤ 10 ppm | Residue on Ignition ≤ 0.1% | ICP-OES / Gravimetric Method |
Orlistat (CAS 96829-58-2) is a semi-synthetic derivative of lipstatin, a natural potent inhibitor of pancreatic lipases produced by the actinobacterium Streptomyces toxytricini. Unlike systemic metabolic modulators, Orlistat exerts its therapeutic activity locally within the lumen of the stomach and small intestine. It covalently binds to the active serine site of gastric and pancreatic lipases via its beta-lactone ring. This covalent inhibition prevents the hydrolysis of dietary triglycerides into absorbable free fatty acids and monoglycerides, thereby reducing caloric absorption by approximately 30% at the standard therapeutic dose of 120 mg three times daily.
Gentolex's proprietary manufacturing methodology utilizes an optimized semi-synthetic pathway. Starting from high-yield, monitored Streptomyces toxytricini fermentation, lipstatin is extracted with ultra-high purity, followed by precise stereoselective catalytic hydrogenation. This process guarantees complete retention of the three chiral centers (2S, 3S, 2'S) critical for biological activity, eliminating stereoisomeric impurities that frequently compromise lower-grade commercial batches.
Empowering pharmaceutical manufacturers with scalable volume, standard-compliant facilities, and rigorous audit capabilities
Strategic insights into the shifting landscape of metabolic treatment APIs and contract manufacturing needs
While injectable peptide-based metabolic drugs (such as GLP-1 and Dual Agonists) dominate clinical headlines, oral non-systemic therapies like Orlistat retain a massive global footprint. Due to its zero systemic bioavailability, predictable side effect profile, and approval for Over-The-Counter (OTC 60mg) dosage forms, demand for high-grade bulk Orlistat API continues to grow at a CAGR of 6.2% across LATAM, Asia-Pacific, and African pharmaceutical markets.
Regulatory authorities including the US FDA, EMA, and WHO have tightened limits regarding trace organic impurities and potential nitrosamine contaminants in synthesized APIs. Leading drug formulators require OEM suppliers who provide comprehensive gas chromatography-mass spectrometry (GC-MS/MS) impurity validation data, ensuring zero regulatory hold times during drug product registration.
Orlistat’s low melting point (approx. 44°C) presents technical challenges in solid dosage manufacturing, such as sticking during tableting or agglomeration in capsule filling. Gentolex offers customized particle size distribution (PSD) micro-milling and specialized pre-formulated pellets (e.g., Orlistat 50% / 60% / 70% Pellets), empowering brand owners to streamline manufacturing without complex in-house granulation.
When selecting an OEM Orlistat CAS 96829-58-2 exporter, procurement directors must evaluate technical capability beyond simple price-per-kilogram quotes. Critical criteria include:
Gentolex’s goal is to create opportunities connecting the world with better services and guaranteed products. Up to date, Gentolex Group has been serving customers from more than 10 countries, specially, representatives are established in Mexico and South Africa. Our main services focus on supplying peptides APIs and Custom Peptides, FDF license out, Technical Support & Consultation, Product Line and Lab Setup, Sourcing & Supply Chain Solutions.
An overall factory construction area of 250,000 square meters under international standard to offer flexible, scalable and cost-effective solutions for global pharmaceutical, biotechnology, and bulk chemical buyers.
An overall factory construction area of 250,000 square meters under international standard to offer flexible, scalable and cost-effective solutions.
Gentolex offers an extensive range of APIs and intermediates for development study and commercial application with cGMP standard from long-term collaborations. Documents and Certificates are supported to customers worldwide.
Custom synthesis, scale-up technology transfer, route scouting, impurity isolation, and analytical testing protocol design for small molecules and peptides.
For those clients who prefer to avoid the complexity of dealing with multiple points of contact, we provide extra customized procurement services with the most superior and comprehensive supply chain sources.
End-to-end quality systems designed for seamless integration into finished dosage form (FDF) manufacturing
Every single commercial lot of Orlistat CAS 96829-58-2 undergoes rigorous analytical clearance before export releases. Testing protocols include LC-MS for structural confirmation, chiral HPLC for enantiomeric purity validation, Karl Fischer titration for water content (≤0.2%), and ICP-MS for trace heavy metals analysis.
To preserve biological activity and prevent thermal or atmospheric degradation, bulk shipments are packed under nitrogen atmosphere. Standard packaging options include 1kg/aluminum foil bags, 5kg/tin drums, and 25kg/fiber drums with double food-grade polyethylene inner liners, supported by cold-chain temp-logger tracking.
We provide full dossier support for market registration worldwide, including CTD-format Drug Master Files (DMF), Stability Study Packages (Zone IVb compliance), Method Validation Reports, and Process Validation Protocols to simplify license-out and technology transfer.
Stay informed with technical research publications and API supply chain updates from Gentolex chemists
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View Details →Key regulatory, analytical, and supply chain insights for global buyers of Orlistat CAS 96829-58-2
Gentolex supplies commercial bulk Orlistat (CAS 96829-58-2) at an assay purity of 99.0% to 101.0% (HPLC baseline), fully compliant with USP, EP, and IP monograph standards. Individual impurities are guaranteed at ≤0.10%, with total impurities controlled under 0.50%.
Given Orlistat's low melting point of 43°C-45°C, exposure to elevated transport temperatures can induce clumping or polymorphic alteration. Gentolex packages orders in temperature-insulated containers with gel cold packs or offers refrigerated reefer container sea/air shipping with real-time temperature data loggers.
We provide full CTD-formatted regulatory dossiers, including Certificate of Analysis (CoA), HPLC/NMR/MS spectral reports, Residual Solvents Certificate (GC-HS), Stability Data (ICH Q1A), Flow Chart of Synthesis, and Open Part DMF access for registration authorities.
Yes. In addition to high-purity pure API powder, we supply pre-formulated, sustained-release or immediate-release Orlistat Pellets (typically 50% or 60% drug load) that eliminate sticking issues and optimize throughput in capsule-filling machinery.
Our standard MOQ for OEM commercial API starts at 1 kg for trial batches up to multi-ton bulk commercial contracts. Inventory is maintained for standard grades, enabling dispatch within 5-7 business days post-audit validation.
We offer customized drum sizes, customized inner lining barriers (double PE or aluminum composite foil bags), tailored drum labeling with your batch numbers and barcodes, and full white-label OEM contract packaging services.
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