Shandong Huashang Chemical Co., Ltd. is a high-tech enterprise focused on industry of fine chemicals research and develop, produce and sale. Shandong Huashang Chemical Co., Ltd. is located in Shan Dong Ji Nan China. we have the ability to provide you high quality products. More than 90 % of our products are exported to developed countries and regions such as north America, Europe, Japan, South Korea and the Middle East.
1. Basic Info
Name: Saxagliptin
Alias: BMS-477118, Onglyza, (1S,3S,5S)-2-[(2S)-2-amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile
CAS No.: 361442-04-8
Molecular Formula: C18H25N3O2
Molecular Weight: 315.41
2. Physical & Chemical Properties
Physical Properties
- Appearance: White to off-white crystalline powder
- Odor: Odorless
- Solubility: Sparingly soluble in water; soluble in methanol, ethanol, isopropanol, acetonitrile, DMSO; slightly soluble in ethyl acetate; insoluble in alkanes
- Melting Point: 103–107 °C
- Density (25℃): 1.35 g/cm3
- Predicted Boiling Point: 548.7±35.0 °C
- Flash Point: 299.8±30.1 °C
- Hygroscopy: Non-hygroscopic
- Storage Temperature Requirement: Short-term 2–8 °C; long-term -20 °C sealed storage
- Optical Activity: Multi-chiral single stereoisomer, fixed S configuration without racemization under normal storage
Chemical Properties
- Complex chiral structure: Contains adamantanol group, aminocarbonyl group, azabicyclohexane nitrile fragment, multiple continuous chiral carbon centers
- Nitrile group activity: Reversibly covalently binds with DPP-4 enzyme active site histidine residue, core pharmacodynamic group
- Amino group characteristic: Primary amino group is weakly alkaline; forms stable salt with inorganic/organic acids
- Thermal stability: Stable below 95 °C; above melting point easy to degrade, nitrile group hydrolyzes to amide impurities
- pH stability: Stable in neutral and weak acid environment; strong alkaline heating triggers hydrolysis of nitrile and amide bonds
- Photostability: Avoid long-term strong UV irradiation; light exposure generates unknown related impurities
- Compatibility: Compatible with common pharmaceutical solvents and excipients; incompatible with strong alkali, strong oxidants, high-temperature aqueous acid
3. Main Application Fields
1. Clinical API for Type 2 Diabetes (Core Application)
Selective reversible DPP-4 inhibitor oral hypoglycemic drug. Inhibits dipeptidyl peptidase-4 to prolong the half-life of endogenous GLP-1 and GIP incretins, promotes glucose-dependent insulin secretion, reduces glucagon secretion, steadily lowers blood glucose with low hypoglycemia risk.
- Monotherapy: Improve blood glucose control based on diet and exercise for patients with mild type 2 diabetes
- Combined therapy: Combined with metformin, sulfonylureas, SGLT-2 inhibitors or insulin to optimize glycemic control for patients with poor single-drug efficacy
2. Pharmaceutical Raw Material & API Intermediate
- Bulk drug raw material for oral saxagliptin tablets; raw material for saxagliptin monohydrate pharmaceutical form
- Synthetic intermediate for DPP-4 inhibitor analogues, used for new hypoglycemic drug structural modification and screening
3. Biochemical Research Reagent
- DPP-4 enzyme specific inhibitor probe for in vitro enzyme activity testing, diabetes mechanism research
- Cell level glucose metabolism experimental tool compound, used for pancreatic β-cell function research
4. Pharmaceutical Standard Reference Substance
High-purity standard for HPLC impurity detection, finished product quality control, pharmaceutical factory process verification
4. Quality Specification Table
| Test Item | Standard Index |
| CAS Number | 361442-04-8 |
| Molecular Formula | C18H25N3O2 |
| Molecular Weight | 315.41 |
| Appearance | White to off-white crystalline powder |
| HPLC Purity | Pharma Grade ≥99.0%; USP/EP Grade 98.0%–102.0% |
| Melting Range | 103.0 ~ 107.0 °C |
| Moisture Content (KF) | ≤0.20% |
| Single Unknown Related Impurity | ≤0.10% |
| Total Related Impurities | ≤0.50% |
| Heavy Metals (Pb) | ≤10 ppm |
| Arsenic (As) | ≤2 ppm |
| Residual Solvents | Meet ICH Q3C limit requirements |
| Bulk Package | 1kg / 5kg vacuum aluminum foil bag, nitrogen-filled sealed |
| Storage Condition | Hermetic nitrogen sealed, 2–8°C dry dark warehouse; isolate high temperature, strong light and alkaline gas |
| Transportation Rule | Low-temperature light-proof and moisture-proof sealed transport |
| Shelf Life | 24 months under intact sealed low-temperature storage |
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