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Orlistat (CAS No. 96827-07-5) is a saturated derivative of lipstatin—a potent natural inhibitor of pancreatic lipases isolated from Streptomyces toxytricini. As a non-systemic, reversible pancreatic and gastric lipase inhibitor, Orlistat acts locally within the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of lipases.
For global pharmaceutical drug product manufacturers, obtaining commercial-scale, ultra-pure Orlistat raw powder requires navigating intricate stereospecific synthesis routes, stringent crystalline polymorphism controls, and precise micronization specifications. Modern pharmaceutical formulations require consistent bulk density, low residual solvent levels, and tight particle size distributions (PSD) to ensure optimal bioavailability and dissolution profiles in finished dosage forms (capsules, tablets, and chewables).
| Parameter | Specification Standard |
|---|---|
| Chemical Name | (S)-((S)-1-((2S,3S)-3-hexyl-4-oxooxetan-2-yl)tridecan-2-yl) 2-formamido-4-methylpentanoate |
| Molecular Formula | C29H53NO5 |
| Molecular Weight | 495.73 g/mol |
| Assay (HPLC) | 98.0% - 102.0% (Anhydrous basis) |
| Melting Point | 43.0°C to 48.0°C |
| Specific Rotation | -30.0° to -33.0° |
| Single Impurity | ≤ 0.14% (ICH Q3A Compliant) |
Understanding the transition from classic microbial fermentation pathways to scalable chemo-enzymatic total synthesis for commercial Orlistat raw powder.
Traditional production relies on Streptomyces toxytricini fermentation to obtain lipstatin, followed by catalytic hydrogenation. Modern Industrial 4.0 plants employ stereo-selective chemical synthesis via asymmetric aldol condensation, eliminating fermentation yield volatility and drastically lowering impurity B and C profiles.
The beta-lactone ring core is extremely sensitive to moisture, temperature, and basic pH environments. Advanced crystallization techniques using specialized organic solvent matrices ensure long-term physical-chemical stability and prevent lactone ring opening during shelf storage.
Because Orlistat acts locally in the GI tract without systemic absorption, dissolution rates correlate directly with particle surface area. We utilize fluid-energy air jet milling to achieve D90 < 10 µm without introducing thermal degradation to the low melting-point API.
As a premier Orlistat raw powder supplier, we support pharmaceutical brands, generic drug manufacturers, and dietary health companies with comprehensive drug delivery solutions.
Orlistat’s low melting point (43°C–48°C) presents challenges during direct compression due to frictional heat. Our customized particle engineering allows for formulation into micro-pellets via extrusion-spheronization. Coating with ethylcellulose buffers against thermal degradation while securing optimal gastro-release profiles in 60mg (OTC) and 120mg (Rx) dosages.
Emerging clinical interest explores combining non-systemic lipase inhibitors like Orlistat with metabolic regulators (such as GLP-1 peptide analogues or hydrophilic dietary fibers) to address comprehensive weight management and hepatic steatosis. We supply pilot-batch APIs with customized impurity profiling for investigative combination drug projects.
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.
Gentolex operates as a cohesive bridge between complex chemical synthesis and seamless international drug delivery. By combining state-of-the-art analytical equipment with agile regulatory support, we drastically shorten product time-to-market for pharmaceutical brands globally.
China's modern pharmaceutical manufacturing sector provides unmatched structural advantages for global B2B procurement. By leveraging automated multi-ton synthesis lines, real-time process analytical technology (PAT), and vertically integrated raw material supply chains, our production facilities ensure price stability and uninterrupted supply resilience.
Our automated production facilities feature centralized SCADA monitoring, dynamic continuous flow reactors, and solvent recovery loops that minimize ecological impact while ensuring multi-ton batch-to-batch consistency.
Navigating market entry requires stringent documentation. We support global registration with full regulatory dossiers.
Our regulatory team provides complete CTD-format Drug Master Files (DMF) to streamline customer submission procedures with national health authorities (FDA, EMA, PMDA, NMPA).
Every commercial batch is supplied with an exhaustive Certificate of Analysis (CoA) including HPLC assay purity, chiral impurity metrics, heavy metals (ICP-MS), and residual solvent gas chromatography (GC).
Accelerated and long-term stability testing reports (25°C/60% RH, 30°C/65% RH, and 40°C/75% RH) conducted under official ICH Q1A guidelines to guarantee 36-month shelf life validation.
High-volume commercial sourcing of Orlistat raw powder requires rigid operational standards across packaging, storage, and cross-border logistics.
| Procurement Parameter | Standard Sourcing Requirement | Gentolex Guaranteed Specification |
|---|---|---|
| Primary Packaging | Moisture-proof, light-resistant food/pharma grade barrier | Double PE inner bags sealed with vacuum aluminum foil under nitrogen flush |
| Secondary Container | Structural protection against compression | High-density fiber drums (25kg net weight) with tamper-evident seals |
| Temperature Logistics | Cold-chain ambient management (<25°C) | Temperature-controlled shipping containers with continuous data loggers |
| Customs Clearance Support | Complete import documentation | Bilingual MSDS, CoA, Certificate of Origin, HS Code 2932209090 classification |
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.
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Our standard pharmaceutical grade Orlistat raw powder guarantees a minimum purity of 98.0% up to 100.5% as tested by HPLC, fully complying with United States Pharmacopeia (USP) and European Pharmacopoeia (EP) standards.
Because Orlistat melts between 43°C and 48°C, we ship commercial quantities using temperature-controlled cold-chain containers equipped with continuous data loggers, double vacuum-sealed aluminum packaging, and desiccants to eliminate humidity risk and thermal degradation.
Yes, we provide specialized micronization services using fluid jet milling. We can customize particle size distribution (e.g., D90 < 10 µm or D50 < 5 µm) tailored to your specific formulation machinery and dissolution requirements.
All bulk orders include a batch-specific Certificate of Analysis (CoA), Safety Data Sheet (MSDS), HPLC and GC spectrum reports, Residual Solvents Analysis, and Certificate of Origin (COO). US-FDA DMF access letters are available for qualified formulation partners.
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