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Comprehensive evaluation of Orlistat (CAS 96827-07-5) for modern obesity management, commercial API synthesis, and metabolic efficacy profiles.
Orlistat (tetrahydrolipstatin) is a potent, irreversible, and highly specific inhibitor of gastrointestinal lipases. Derived chemically as a saturated derivative of lipstatin—a natural product isolated from Streptomyces toxytricini—Orlistat exerts its therapeutic activity locally within the lumen of the stomach and small intestine. Unlike systemic anti-obesity agents that act via central nervous system appetite suppression, Orlistat's unique non-systemic mechanism minimizes central side effects while offering documented cardio-metabolic benefits.
As a leading bulk pharmaceutical manufacturer, Gentolex maintains strict quality control over every batch of Orlistat API. Our analytical testing protocols adhere to USP, EP, and IP standards, ensuring zero residual solvents, negligible impurity profiles (specifically Impurity A through F), and optimized particle size distribution for hard gelatin encapsulation.
| Parameters | Specification Benchmark | Testing Methodology |
|---|---|---|
| Chemical Formula / CAS No. | C29H53NO5 / CAS 96827-07-5 | High-Resolution MS & NMR Identification |
| Appearance | White to off-white crystalline powder | Visual / Colorimetric Standard |
| Assay (On Anhydrous Basis) | 98.0% – 101.5% | RP-HPLC Assay |
| Specific Optical Rotation [α]D20 | -43.0° to -48.0° | Polarimetry (c=1 in ethanol) |
| Related Substances (Total Impurities) | ≤ 1.0% (Single Impurity ≤ 0.2%) | Validated Gradient HPLC Method |
| Heavy Metals / Ignited Residue | ≤ 10 ppm / ≤ 0.1% | ICP-MS / Gravimetric Analysis |
Leveraging massive modern chemical synthetic capacity, cost efficiency, and backward integrated supply chains to support global pharmaceutical brands.
Our state-of-the-art production base operates under rigorous international quality management systems, featuring multi-ton synthesis reactors, automated cleanrooms, and automated crystallization equipment tailored for high-purity APIs.
By controlling key chemical precursors and building blocks directly in China, Gentolex isolates production from global raw material supply disruptions, guaranteeing fixed pricing, reliable lead times, and continuous product availability.
Our advanced process analytical technology (PAT) monitors inline particle size, polymorph formation, and moisture levels during synthesis, maintaining unwavering standard compliance across metric-ton scale batches.
Gentolex Group serves generic pharmaceutical companies, contract development and manufacturing organizations (CDMOs), and health-tech enterprises across more than 10 countries. Beyond API bulk production, our service package includes:
Enabling seamless market expansion with dedicated regional offices in Latin America and Africa, backed by internationally compliant technical dossiers.
Our dedicated representative center in Mexico provides localized client management, simplified regulatory support for COFEPRIS filings, and regional warehousing flexibility for LATAM pharmaceutical formulators.
Gentolex's established South Africa operations cater directly to regional pharmaceutical suppliers, facilitating expedited regulatory submissions to SAHPRA and simplifying cross-border logistical hurdles.
We maintain fully structured eCTD format Drug Master Files (DMF) ready for cross-referencing, streamlining your ANDA or marketing authorization applications with regulatory bodies worldwide.
Market dynamics: Positioning Orlistat alongside injectable peptides in the evolving weight loss ecosystem.
The global anti-obesity market is undergoing unprecedented expansion. While GLP-1 receptor agonists (such as Semaglutide and Liraglutide) have captured substantial market share for systemic appetite regulation, oral lipase inhibitors like Orlistat maintain a critical, non-overlapping market segment:
Stay informed with the latest scientific articles, manufacturing insights, and therapeutic peptide innovations from our R&D technical team.
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View Technical ArticleDetailed answers for pharmaceutical procurement heads, formulation scientists, and regulatory officers regarding Orlistat API sourcing.
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