Introducing our cutting-edge pharmaceutical product, Ticagrelor, a revolutionary medication designed to combat platelet aggregation and improve blood flow in patients with various cardiovascular conditions. This innovative drug is set to transform the landscape of antiplatelet therapies, providing safer and more effective options for patients in need.
What is Ticagrelor?
Ticagrelor is an oral antiplatelet medication that falls under the class of P2Y12 receptor antagonists. It works by inhibiting platelet activation, preventing the formation of blood clots, and reducing the risk of serious cardiovascular events, such as heart attacks and strokes.
How Does Ticagrelor Work?
Ticagrelor exerts its effects by selectively blocking the P2Y12 receptors on the surface of platelets, which are responsible for initiating the platelet aggregation process. By doing so, Ticagrelor interrupts the activation and clumping of platelets, thus preventing the formation of harmful blood clots in arteries and veins.
Unlike traditional antiplatelet agents, Ticagrelor offers a reversible and fast-acting mechanism of action. This means that once the medication is discontinued, the platelet function returns to normal more quickly, reducing the risk of prolonged bleeding complications.
Key Features and Benefits:
1:Efficacy: Ticagrelor has demonstrated remarkable efficacy in clinical trials, reducing the incidence of major cardiovascular events in high-risk patients.
2:Fast Onset: Unlike other antiplatelet drugs, Ticagrelor's rapid onset of action provides immediate platelet inhibition, offering swift protection in critical situations.
3:Reversibility: Ticagrelor's reversible binding ensures that its effects wear off promptly after discontinuation, minimizing the risk of excessive bleeding during medical interventions.
4:Stability: Ticagrelor remains stable even in patients with certain genetic variations that may impact the response to other antiplatelet medications.
5:Dosing Flexibility: The convenient oral administration and flexible dosing options allow for personalized treatment plans tailored to individual patient needs.
Indications:
Ticagrelor is indicated for the prevention of atherothrombotic events in the following conditions:
1:Acute Coronary Syndromes (ACS): Ticagrelor is recommended for patients with unstable angina, non-ST-segment elevation myocardial infarction (NSTEMI), or ST-segment elevation myocardial infarction (STEMI) undergoing medical management or percutaneous coronary intervention (PCI).
2:Secondary Prevention: Ticagrelor is prescribed to reduce the risk of recurrent cardiovascular events in patients with a history of heart attack or ischemic stroke.
Batch No. |
DK74-2109201 |
Batch Size |
70.28kg |
|
Package Size |
25.00kg/Drum |
Manufacturing Date |
20 SEP 2021 |
|
Issuing Date |
13 Jun 2023 |
Retest Date |
19 SEP 2023 |
|
Quality Specification |
RO-CEP 2022-187-Rev 00 |
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Items |
Specification |
Results |
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CHARACTERS |
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Appearance |
White or almost white to pale pink powder. |
Almost white powder |
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IDENTIFICATION |
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IR |
IR spectrum of sample conforms to that of reference standard. |
Complies |
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TESTS |
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Related substances |
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Impurity D |
NMT 0.3% |
<0.02% |
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Impurity A |
NMT 0.2% |
<0.02% |
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Impurity B |
NMT 0.2% |
<0.02% |
||
Impurity C |
NMT 0.1% |
0.09% |
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Any unspecified impurities |
NMT 0.10% |
0.01%(RRT:0.86) 0.02%(RRT:0.95) 0.02%(RRT:0.96) 0.03%(RRT:1.14) 0.05%(RRT:1.17) |
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Total impurities |
NMT 1.0% |
0.23% |
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Residual solvents |
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Ethyl acetate |
NMT 5000ppm |
80ppm |
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Impurity E |
NMT 8ppm |
1.2ppm |
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Water |
NMT 0.5% |
0.16% |
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Sulfated ash |
NMT 0.6% |
0.03% |
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ASSAY(on anhydrous basis |
97.5%-102.0%₀fC₂₃H₂₈F₂N₆O₄S |
100.3% |
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Conclusion: The results☑conform to □ do not conform to the specification. |
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This batch of API has been manufactured in accordance with cGMPs. |
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Storage condition: In an airtight container, protected from light. |
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Remarks: / |
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Shipped quantity: |
Add: Block 14, No.100, Luyun Road,Changsha 410205, Hunan, China.
Telephone: +8618688784456
Email: info@arshinepharma.com
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