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Sinoway Industrial Co.Ltd.
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Product name
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Valsartan
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CAS No.
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137862-53-4
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Molecular Formula
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C24H29N5O3
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Molecular Weight
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435.519
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Quality Standard
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98% up, USP/JP/EP
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Appearance
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White to almost white powder
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ITEMS
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STANDARDS
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RESULTS
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Appearance
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White to almost white powder
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White powder
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Identification
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Infrared absorption:
The IR spectrum is consistent with that obtained with the reference
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Conforms
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The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the assay
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Conforms
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Absorbance
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NMT 0.02
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0.003
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Water
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NMT2.0%
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0.56%
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Residue on ignition
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NMT0.1%
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0.06%
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Heavy metals
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NMT0.001%
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Related compounds
(HPLC)
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Compound A NMT1.0%
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0.49%
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Compound B NMT0.2%
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0.08%
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Compound C NMT0.1%
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Undetected
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Any other individual impurity NMT0.1% (excluding compound A )
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0.04%
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Total impurities NMT0.3% (excluding compound A )
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0.20%
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Residual solvents(GC)
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Ethyl acetate NMT5000ppm
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2820ppm
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Dichloromethane NMT600ppm
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Undetected
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Methanol NMT3000ppm
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Undetected
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N,N-Dimethylformamide NMT880ppm
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Undetected
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Assay
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98.0—102.0%
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99.2%
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Conclusion
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The analysis results show that this batch of valsartan conforms to USP
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Function of Valsartan
Valsartan is an angiotensin II receptor antagonist anti-hypertensive drug. The drug can block the type I (AT1) receptor of angiotensin II, increase the plasma level of angiotensin II and stimulate The unblocked AT2 receptor also counteracts the role of the AT1 receptor, so as to achieve the effect of dilating blood vessels and lowering blood pressure, the effect is lasting and stable, and the toxic and side effects are small. Therefore, valsartan is mainly suitable for antihypertensive, mild to moderate primary hypertension, especially for the treatment of secondary hypertension caused by kidney damage. |
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Lewoo Pharmatech(Shanghai)Co.,Ltd
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ValsartanImpurity18;Valsartan3-Methyl-2-[pentanoyl-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]amino]-butanoicacid;ValsartanRelatedCompoundA(10mg)((R)-N-Valeryl-N-([2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine);N-(1-oxopentyl)-N-[[2'-(1H-tetrChemicalbookazol-5-yl)[1,1'-;N-(1-Oxopentyl)-N-[[2’-(1H-tetrazol-5-y1)[1，1'-biphenyl]-4-y1]methyl]-L-valine;L-Valine,N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-;N-(1-Oxopentyl)-N-[[2'-(2H-tetrazo-5-yl);Valsartan(350mg)G0F0650.997mg/mg(an) |
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Shanghai Pharma Group Changzhou Kony Pharmaceutical Co.,Ltd.
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Kang Li (Changzhou) Pharmaceutical Co., Ltd. is a professional manufacturer of raw materials and pharmaceutical intermediates.Kang Li (Changzhou) Pharmaceutical Co., Ltd. is a professional manufacturer of raw materials and pharmaceutical intermediates.
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