Our high-purity Sibutramine powder (CAS 106650-56-0) is synthesized and refined under an international standard quality management system. The material undergoes multi-stage chemical recrystallization to achieve a stable crystalline structure with exceptionally low volatile impurities and minimal hygroscopicity.
Engineered for professional industrial compounding and laboratory scale-up, this bulk active ingredient exhibits optimized powder flowability and excellent solubility in organic solvents (methanol/ethanol), making it fully compatible with automated solid-dosage processing-including high-speed automated capsule filling and tablet matrix compaction. By maintaining a highly reproducible impurity profile, we ensure that research institutes and pharmaceutical quality control (QC) labs receive consistent, fully non-deviating analytical data across all operational batches.
Definitive Technical Specifications
The analytical parameters listed below represent standard specifications for our commercial production batches. Every shipment is backed by a batch-specific Certificate of Analysis (COA) to support technical audits.
|
Analytical Parameter |
Specification Standard |
Representative Batch Result |
|
Active Ingredient |
Sibutramine Powder |
Compliant |
|
CAS Registry Number |
106650-56-0 |
Verified |
|
Molecular Weight |
279.85 g/mol |
Confirmed |
|
Physical Appearance |
White or off-white crystalline powder |
White uniform crystalline powder |
|
Solubility Profile |
Freely soluble in Methanol and Ethanol; practically insoluble in Water |
Compliant |
Quality Assurance & Instrumentation Methodology
Quality control is executed throughout the entire manufacturing cycle-from precursor screening to final crystal drying-ensuring strict alignment with global pharmaceutical ingredient standards.
Our production base operates under rigid industrial quality controls, utilizing advanced multi-stage recrystallization processes to systematically isolate and remove related substances, residual organic solvents, and heavy metal ions. Every batch is cataloged with a unique tracking code, raw batch manufacturing records, and historical chromatograms, ensuring complete data traceability required by industrial procurement auditors.
To verify structural integrity and purity metrics, our quality assurance department utilizes high-precision testing methodologies:
● High-Performance Liquid Chromatography (RP-HPLC): Employed for definitive assay validation and quantitative evaluation of related impurities, ensuring an exact purity profile accurate to 0.01%.
● Gas Chromatography-Mass Spectrometry (GC-MS / HS-GC): Utilized for headspace profiling of residual organic solvents, keeping volatile compounds well within international safety limits.
● Elemental & Elemental Impurity Analysis: Monitored to screen out trace heavy metals (such as arsenic, lead, and mercury) and microbial counts, aligning with chemical raw material safety thresholds.
Main Commercial Application Fields
Prescription Drug Formulation R&D
Utilized by licensed pharmaceutical corporations as a core active pharmaceutical ingredient (API) for clinical trial evaluation, metabolic drug compatibility testing, and pilot-scale therapeutic formulation development.
Analytical Calibration Reagents
Deployed by commercial testing facilities, independent calibration laboratories, and university research divisions as reference standards for chromatography validation and instrumentation tuning.
Neuroendocrine Research Projects
Serving as an established neurotransmitter reuptake inhibitor model compound for in vitro and in vivo academic trials studying central nervous system metabolic pathways and satiety receptor mechanics.
Post-Sales & Technical Support Policy
Comprehensive Dossier Delivery
Every shipment includes a complete documentation package, featuring the batch-specific Certificate of Analysis (COA), standard HPLC purity charts, and a globally compliant Safety Data Sheet (SDS/MSDS).
Technical Consultation
Our chemical engineering team provides technical alignment for B2B procurement partners, assisting with solubility queries, storage stability monitoring, and analytical methodology replication.
Batch Verification Window
We provide a 30-day quality evaluation window upon cargo arrival at your corporate warehouse. In the rare event of an analytical discrepancy verified via standard compendial testing, our laboratory will coordinate within 48 hours for cross-methodology calibration and facilitate necessary recall or replacement processes.
Framework Continuity Reserves
For strategic procurement partners with active annual supply agreements, we maintain dedicated safety reserves to buffer against market raw material fluctuations and ensure consistent batch data replication.
FAQ
Q1: Can your Sibutramine powder pass third-party testing verification?
A: Yes. Every commercial batch is strictly standardized to achieve an HPLC purity of 99% Our materials are fully auditable by established independent testing bodies (such as SGS or Eurofins) using standard liquid chromatography methods.
Q2: Can this material be processed into dietary supplements or health-store formulas?
A: Absolutely not. This product is classified as a regulated pharmaceutical active ingredient (API). Under global compliance laws, it cannot be legally added to over-the-counter slimming products, functional foods, or public herbal mixtures. We enforce strict due diligence to restrict supply exclusively to legitimate research and industrial pharmaceutical buyers.
Q3: What is your Minimum Order Quantity (MOQ)? Do you supply small retail bags?
A: Our standard commercial Minimum Order Quantity is 25kg (supplied as 1 full industrial drum). To eliminate distribution risks and retail diversion, we do not package materials into 10g, 50g, or 1kg consumer configurations.
Packaging & Logistics Architecture
Industrial Packaging Standard
To eliminate cross-contamination and moisture ingress during international maritime or air transit, we utilize heavy-duty multi-tier industrial shielding:
● Traceable Identification: Each container features an official industrial label detailing product nomenclature, production batch number, manufacturing date, and safety codes for automated ERP inventory logging.
Freight Operations
We coordinate with top-tier international freight forwarders specialized in chemical logistics to manage global door-to-port or door-to-bonded-warehouse distribution:
● Documentation & Customs Clearance: All shipments are processed with compliant international customs declarations, chemical safety registrations, and clear logistical routing.
● Consignment Security: Bulk orders feature end-to-end transport tracking and transit coverage. Purchasing entities are required to verify their regional import eligibility prior to dispatch scheduling.
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