Introduction: Welcome to the world of Dapagliflozin, a groundbreaking medication designed to enhance diabetes management by inhibiting sodium-glucose cotransporter 2 (SGLT2). Dapagliflozin belongs to the class of sodium-glucose cotransporter 2 inhibitors, which work by reducing glucose reabsorption in the kidneys. This innovative medication offers effective glycemic control and provides numerous benefits for individuals living with type 2 diabetes. Let's delve into the wonders of Dapagliflozin and its impact on diabetes management.
The Power of Dapagliflozin: Dapagliflozin's mechanism of action centers around the kidneys, where it inhibits the reabsorption of glucose. By doing so, it promotes the excretion of excess glucose in the urine, leading to lowered blood glucose levels. This process not only aids in managing hyperglycemia but also offers additional advantages for cardiovascular and renal health.
Benefits of Dapagliflozin:
1:Glycemic Control: Dapagliflozin is a valuable addition to the treatment regimen of individuals with type 2 diabetes, as it helps lower blood glucose levels and improves overall glycemic control.
2:Weight Loss: Dapagliflozin's mechanism of glucose excretion in the urine is associated with modest weight loss, making it particularly beneficial for those aiming to manage body weight.
3:Cardiovascular Benefits: Clinical studies have shown that Dapagliflozin provides cardiovascular benefits by reducing the risk of major adverse cardiovascular events in certain high-risk individuals.
4:Renal Protection: Dapagliflozin has been found to slow the progression of kidney disease and reduce the risk of renal-related complications in patients with type 2 diabetes and pre-existing kidney issues.
5: Convenient Once-Daily Dosage: Dapagliflozin is typically taken once daily, offering a convenient dosing schedule that supports treatment adherence.
Batch No. |
23010201 |
Mfg. Date |
2023-01-02 |
Ret. Date |
2025-01-01 |
Rpt. Date |
2023-01-09 |
Source |
Workshop |
||
QCS |
2020 of Enterprise Standard |
TESTS |
STANDARD |
RESULTS |
Appearance |
White to off-white powder |
White powder |
Melting point |
72〜80°C |
74.7-75.9°C |
Optical rotation |
+ 13。〜+17° |
+ 14.6° |
Identification |
HPLC RT |
Conform |
UV |
Conform |
|
Water |
3.0% 〜4.4% |
3.61% |
Residue on ignition |
≤0.10% |
0.08% |
Heavy metals |
≤20ppm |
<20ppm |
Chiral impurity |
≤0.15% |
0.09% |
Perce ntage of propa nediol |
13.6% 〜16.6% |
15.3% |
|
Methanol<3000ppm |
ND |
Residual solvents |
Ethanol≤5000ppm |
ND |
Acetonitrile≤410ppm |
ND |
|
Dichloromethane≤600ppm |
ND |
|
Ethyl acetate≤5000ppm |
650ppm |
|
N-Hexane≤290ppm |
146ppm |
|
THF≤720ppm |
ND |
|
Toluene≤890ppm |
ND |
|
Related impurities |
Any individual impurity≤0.10% |
0.04% |
Total impurities ≤1.0% |
0.16% |
|
Purity |
≥99.0% |
99.84% |
HPLC assay |
98.0%- 102.0% |
99.8% |
Conclusion: Complies With 2020 of Enterprise Standard |
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