High-purity chemical APIs and custom research peptides engineered under cGMP standards for worldwide distribution.
Understanding the technical specifications, synthesis pathways, and pharmaceutical standards of Orlistat CAS 96827-07-5.
Orlistat (tetrahydrolipstatin) is a potent, irreversible inhibitor of gastric and pancreatic lipases. Chemically identified as (1S)-1-[[(2S,3R)-3-hexyl-4-oxooxetan-2-yl]methyl]dodecyl (2S)-2-formamido-4-methylpentanoate, it exerts its therapeutic effect directly within the lumen of the stomach and small intestine. By forming a covalent bond with the active serine site of lipases, Orlistat prevents the hydrolysis of dietary triglycerides into absorbable free fatty acids and monoglycerides, thereby reducing dietary fat absorption by approximately 30%.
In industrial pharmaceutical manufacturing, reaching a assay standard of HPLC Purity ≥ 98.0% is non-negotiable. Lower purity grades harbor unwanted synthetic side-products, stereo-isomeric impurities (such as the 2S,3S-diastereomer), and solvent residues. Achieving 98%+ guarantees minimal enzymatic cross-reactivity, optimal crystallization behavior, superior physical flowability for capsule encapsulation, and strict compliance with ICH Q3A guidelines regarding organic impurities.
Why Chinese chemical manufacturers lead the global supply chain in high-purity lipase inhibitor synthesis and bulk API scalability.
China’s pharmaceutical industry has mastered the complex dual-step manufacturing route for Orlistat: initial biological fermentation of Streptomyces toxytricini to generate natural lipstatin, followed by highly stereoselective catalytic hydrogenation. This hybrid bio-synthetic expertise yields purities consistently surpassing 98% with minimal downstream waste.
With complete localized access to essential amino acids, N-formyl-L-leucine derivatives, and specialized chiral catalysts, Chinese suppliers mitigate global supply chain bottlenecks. Complete vertical integration allows for stable pricing dynamics and batch-to-batch consistency that international buyers require.
Modern Chinese chemical industrial parks feature state-of-the-art Zero Liquid Discharge (ZLD) systems and automated cGMP synthesis bays. Sourcing Orlistat 98% from regulatory-compliant Chinese suppliers guarantees long-term supply chain security without the risk of sudden environmental closures.
Comprehensive analytical thresholds validated via High-Performance Liquid Chromatography (HPLC) and Nuclear Magnetic Resonance (NMR).
| Parameter Test Item | Analytical Method | USP / EP Target Standard | Gentolex Batch Benchmark |
|---|---|---|---|
| Appearance | Visual Inspection | White to off-white crystalline powder | Conforms (Pure White Powder) |
| Chemical Assay (Purity) | HPLC (External Standard) | 97.0% – 102.0% (Dried basis) | 98.6% – 99.4% |
| Specific Optical Rotation | Polarimetry [α]D20 | -43.0° to -48.0° | -45.5° |
| Related Impurities (Single) | HPLC-UV | ≤ 0.2% | < 0.08% |
| Total Impurity Threshold | HPLC-UV | ≤ 1.0% | < 0.45% |
| Heavy Metals Content | ICP-MS | ≤ 10 ppm | < 3 ppm |
| Loss on Drying (LOD) | Gravimetric (Thermal) | ≤ 0.5% | 0.18% |
| Melting Range | Capillary Melting Apparatus | 43.0°C – 48.0°C | 44.5°C – 46.0°C |
How enterprise pharmaceutical brands utilize 98% pure Orlistat API across distinct medical and commercial formulations.
Orlistat 98% API is the preferred active substance for over-the-counter (OTC) 60mg hard gelatin capsules. Its non-systemic action profile makes it exceptionally popular for consumer health markets seeking safe, non-stimulant weight management drugs that restrict fat absorption without affecting the central nervous system.
For clinical management of severe obesity and type-2 diabetes co-morbidities, 120mg prescription dosage forms require high purity API to guarantee tight release profiles. Combining 98% Orlistat with dietary intervention offers consistent metabolic parameters and visceral fat reduction.
Modern biopharmaceutical research investigates synergistic protocols pairing peripheral lipase inhibitors (Orlistat) with systemic metabolic peptides (such as Semaglutide or Liraglutide). This multi-pathway approach targets both central appetite suppression and peripheral lipid digestion inhibition.
Connecting the world with guaranteed pharmaceutical APIs, custom synthesis, and international supply chain infrastructure.
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 allows us to offer flexible, scalable and cost-effective solutions.
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.
Advanced R&D labs specialized in custom synthetic routes, chiral isolation, peptide purification, and strict quality control assays.
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.
Meeting international regulatory benchmarks with standard Drug Master Files (DMF), stability data, and rigorous audit readiness.
Every batch of Orlistat 98% API is supported by standard CTD-format documentation, including open-part Drug Master Files (DMF), Certificate of Analysis (CoA), BSE/TSE-free declarations, Residual Solvent Statements (ICH Q3C), and stability studies under zone IVb conditions.
Due to Orlistat’s low melting point (~44°C), thermal degradation must be strictly avoided during transit. Bulk orders are packaged in double polyethylene-lined fiber drums with vacuum desiccant seals, shipped under controlled temperature logistics (+2°C to +8°C) to maintain stability.
From pilot-scale 1kg trials for formulation development to multi-ton industrial supply agreements, Gentolex offers scalable commercial terms, competitive spot pricing, and customized delivery schedules for pharmaceutical leaders worldwide.
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