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25 Kilogram |
Negotiable |
Sacubitril Valsartan Sodium LCZ696 Sacubitril Valsartan
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Product name |
Sacubitril Valsartan sodium/ LCZ696 |
CAS No. |
936623-90-4 |
Molecular Formula |
2(C24H29N5O3).2(C24H29NO5).5(H2O).6Na |
Molecular Weight |
958.008 |
Molecular Structure |
|
Quality Standard |
98% up by HPLC with total impurities < 0.05% |
Appearance |
White or almost white powder |
ANALYSIS |
SPECIFICATION |
RESULTS |
Appearance |
White or almost white powder |
White powder |
Identification |
IR: Spectrum should correspond to reference substance |
Conforms |
UV: Spectrum should correspond to reference substance |
Conforms |
|
XRPD: Spectrum should correspond to reference substance |
Conforms |
|
Water |
4.0% - 5.9% |
4.96% |
Heavy metals |
≤10ppm |
Conforms |
Stereoisomers |
SCB(S,S) ≤ 0.15% |
N.D. |
SCB(S,R) ≤ 0.15% |
N.D. |
|
SCB(R,R) ≤ 0.15% |
N.D. |
|
VST impurity A ≤ 0.5% |
N.D. |
|
Related substance |
SCB impurity A ≤ 0.10% |
N.D. |
SCB Impurity B ≤ 0.10% |
N.D. |
|
SCB Impurity C ≤ 0.10% |
N.D. |
|
SCB Impurity D ≤ 0.10% |
N.D. |
|
SCB Impurity E ≤ 0.10% |
N.D. |
|
Other single impurity ≤ 0.10% |
0.05% |
|
Total impurities ≤ 1.0% |
0.05% |
|
Sodium |
7.17% - 7.93% |
7.30% |
Assay |
Sacubitril: 43.5%-46.5% |
44.5% |
Valsartan: 46.2%-49.2% |
47.4% |
|
Sacubitril valsartan sodium: 98.0% -101.5% |
99.2% |
|
Conclusion |
The product meets In-house specification |
What is Sacubitril Valsartan Sodium
Sacubitril Valsartan Sodium(LCZ696) is a type of drug that is commonly used to treat heart failure. It is a combination of two different drugs, Sacubitril and Valsartan, which work together to help improve the function of the heart.
Sacubitril is a neprilysin inhibitor that blocks the breakdown of brain natriuretic peptide (BNP) and its related peptides. This helps to increase levels of these peptides in the blood, which then help to relax blood vessels and reduce blood pressure. Valsartan is an angiotensin II receptor blocker (ARB) that blocks the action of angiotensin II on its receptors. Angiotensin II is a hormone that constricts blood vessels and increases blood pressure. By blocking the action of angiotensin II, Valsartan helps to relax blood vessels and reduce blood pressure.
Sacubitril Valsartan Sodium is used to treat patients with heart failure who have reduced ejection fraction, which means that the heart is not pumping blood effectively. It is thought to help improve heart function by blocking the breakdown of BNP and reducing blood pressure.
The safety and effectiveness of Sacubitril Valsartan Sodium has been established in clinical trials, and it is currently approved for use in many countries worldwide.
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