Dapagliflozin Raw Powder API CAS No: 960404-48-2
Dapagliflozin Raw Powder API CAS No: 960404-48-2
Dapagliflozin,960404-48-2,Dapagliflozin Raw Powder API CAS No: 960404-48-2,Dapagliflozin Raw Powder API,CAS No: 960404-48-2
Product Name: Dapagliflozin Raw API Powder
Product Purity: ≥99.0%
CAS No：960404-48-2
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Description
Dapagliflozin Raw Powder API
Premium SGLT2 Inhibitor Manufacturer | High-Purity Pharmaceutical Grade CAS 960404-48-2 Supplier
Handling & Storage:
Highly stable in solid crystalline state. Store in a tightly closed container at desiccated conditions. For long-term commercial stockpiling, storage below 25°C (or refrigerated at 2-8°C) is recommended to ensure 24-month optimal stability.
Highly stable in solid crystalline state. Store in a tightly closed container at desiccated conditions. For long-term commercial stockpiling, storage below 25°C (or refrigerated at 2-8°C) is recommended to ensure 24-month optimal stability.
Product Technical Overview
Dapagliflozin (CAS 960404-48-2) manufactured and supplied by Shaanxi Sunrise Pharmaceutical Co., Ltd. is an elite-grade, highly selective Sodium-Glucose Co-transporter 2 (SGLT2) inhibitor active pharmaceutical ingredient (API). Structurally, Dapagliflozin is a C-aryl glycoside compound featuring an anhydrous D-glucitol core linked to an ethoxybenzyl-chlorobenzene moiety.
Unlike conventional diabetes therapeutic agents, our high-purity Dapagliflozin raw powder acts via an insulin-independent renal pathway, making it highly compatible with multi-drug oral solid dosage forms (OSD). Our process ensures strict control over alpha-anomer impurities, heavy metal residues, and organic volatile solvents in compliance with international pharmacopoeia standards.
| CAS Number | 960404-48-2 (Free Base) | 960404-59-5 (Propanediol Monohydrate) |
| Chemical Name | (2S,3R,4R,5S,6R)-2-[4-chloro-3-(4-ethoxybenzyl)phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol |
| Molecular Formula | C21H25ClO6 (Anhydrous Free Base) |
| Molecular Weight | 408.87 g/mol |
| Assay (Dried Basis) | 99.0% – 101.0% (HPLC Verification) |
| Appearance | White to off-white, crystalline powder |
| Melting Point | 74°C - 78°C (Amorphous/Free base range) |
| Standard Pack | 1 kg/bag (aluminum vacuum-sealed); 25 kg/cardboard drum |
| Shelf Life | 24 Months |
Core Industrial Advantages
Insulin-Independent Pathway
Dapagliflozin targets renal proximal tubules specifically, bypassing systemic pancreatic insulin pathways. This unique mechanism of action remains highly consistent and effective regardless of patient insulin resistance levels or beta-cell decline.
Superior Crystal Form Stability
We employ advanced controlled crystallization technologies to ensure optimal flowability, bulk density, and particle size distribution. This superior solid-state profile minimizes friction and prevents clumping during high-speed tableting or encapsulation.
Rigorous Global Compliance
Every production run undergoes thorough batch verification. We control single maximum impurities ≤ 0.10% and total related substances ≤ 0.50%, conforming fully to European Pharmacopoeia (EP) and United States Pharmacopoeia (USP) guidelines.
Mechanism of Action & Cardio-Renal Value
Dapagliflozin targets the renal glucose filtration and reabsorption processes to deliver multi-organ metabolic protection:
Selective SGLT2 Inhibition: By reversibly blocking the SGLT2 cotransporters in the S1 segment of the renal proximal convoluted tubule, Dapagliflozin reduces glucose reabsorption, facilitating excretion of approximately 70g of glucose per day through urine.
Hemodynamic & Cardio-Renal Protection: SGLT2 blockade increases sodium delivery to the macula densa, promoting tubuloglomerular feedback and reducing intraglomerular pressure. This action significantly slows the progression of diabetic nephropathy and decreases myocardial wall stress.
Osmotic Diuresis: The combined excretion of sodium and glucose induces mild osmotic diuresis, helping to reduce intravascular volume and assist in systemic blood pressure management.
Typical Certificate of Analysis (COA)
| Test Parameter | Specification Limit (EP/USP) | Actual Batch Analysis | Analytical Method |
|---|---|---|---|
| Appearance | White to off-white crystalline powder | Conforms | Visual Method |
| Identification | Conforms to Reference Infrared Spectrum (IR) | Conforms | USP<197k><!--197k--> |
| Assay (HPLC, Dried Basis) | 99.0% – 101.0% | 99.65% | Liquid Chromatography |
| Specific Optical Rotation | -50.0° to -54.0° | -52.4° | Polarimetry USP<781><!--781--> |
| Loss on Drying | ≤ 0.5% | 0.18% | 105°C vacuum drying |
| Residue on Ignition | ≤ 0.1% | 0.04% | Gravimetric USP<281><!--281--> |
| Heavy Metals | ≤ 10 ppm | ≤ 5 ppm | ICP-MS Method |
| Single Max Impurity | ≤ 0.10% | 0.06% | HPLC Area Normalization |
| Total Impurities | ≤ 0.50% | 0.21% | HPLC Area Normalization |
Technical Support & FAQ
What crystalline forms of Dapagliflozin do you supply?
Shaanxi Sunrise manufactures the standard amorphous/crystalline free base form (CAS 960404-48-2) as well as the high-stability Dapagliflozin Propanediol Monohydrate form (CAS 960404-59-5). Please specify your preferred polymorph during sample requisition.
Are regulatory filing documents available?
Yes, Shaanxi Sunrise Pharmaceutical supports global drug registration. We can provide full analytical validation data, CMC dossier components, stability testing under ICH conditions, complete COA, and MSDS packages.
How do you control genotoxic impurities in this API?
Our synthesis pathway avoids the generation of harmful alkylating agents. Any potential mutagenic intermediates are strictly monitored and cleared below the TTC (Threshold of Toxicological Concern) limit in accordance with ICH M7 guidelines.
⚠ Safety Warning & Regulatory Declaration
Mandatory B2B Compliance Notice: This product is an active pharmaceutical ingredient (API) intended exclusively for industrial-scale manufacturing, commercial formulation development, and scientific laboratory research. Shaanxi Sunrise Pharmaceutical Co., Ltd. does not sell chemical raw materials to private individuals or for direct therapeutic consumption. All prospective buyers must be verified corporate entities, research facilities, or licensed pharmaceutical manufacturers.