Cp USP EP Valsartane

Valsartane
Valsartan
Valsartan is an angiotensin II receptor antagonist antihypertensive drug. This drug works by blocking the type I (AT1) receptor of angiotensin II, increasing the plasma level of angiotensin II, stimulating the unblocked AT2 receptor, and simultaneously counteracting the AT1 receptor, thereby achieving the effect of dilating blood vessels and lowering blood pressure. In the United States, valsartan is a drug used to treat hypertension, congestive heart failure and post-myocardial infarction. The valsartan developed and produced by Ciba-Gaki of Switzerland was granted relevant patent rights in the United States and Europe in 1995 and 1996 respectively. It was first launched in Germany in July 1996 and has since been successively launched in Europe, the United States and Japan. Ciba - Gaki Company and Sandoz Company merged to form Novartis in 1996. Valsartan is characterized by its long-lasting and stable antihypertensive effect and low toxic and side effects [1].
Basic information
Chinese name: Valsartan
Chinese alternative name: Ambroxol Hydrochloride Impurity ; Dai Wen Valentin sartan Mai Xin
English name: valsartan
English alias: Valsartane "Tareg;" Valsartan API Valsratan; Diovan
CAS Number: 137862-53-4
Molecular formula: C24H29N5O3
Molecular weight: 435.51900 \ nPrecise mass: 435.22700 \ nPSA: 112.07000 \ nLogP: 4.16170 \ n [1] Physical and chemical properties \ nAppearance and characteristics: This product is a white crystal or white, off-white powder. It is hygroscopic. 

Density: 1.212g/cm ³ \ nMelting point: 116-117°C \ nBoiling point: 684.9 °C at 760 mmHg \ nFlash point: 368 °C \ nRefractive index: 1.586 \ nStorage conditions: Keep in a cool and dark place \ nVapor pressure: 1.06E-19mmHg at 25°C

Pharmacopoeia standards
Broadcast
Source (name), content (potency)
This product is  Calculated on a dry basis, it shall contain no less than 98.5% of C24H29N5O3.
Trait
This product is a white crystal or a white, off-white powder. It is hygroscopic.
It is almost insoluble in water.
Specific rotation degree
Take this product, accurately weigh it,  and quantitatively dilute it to a solution containing approximately 10mg per 1ml. Determine it according to the method (Appendix ⅥE of the 2010 Edition of the Pharmacopoeia, Part II), and the specific rotation is -64.0° to -69.0°.
Identification
Take this product,  and dilute it to prepare A solution containing approximately 15μg per 1ml. Determine it by ultraviolet-visible spectrophotometry (Appendix IVA of the 2010 Edition of the Pharmacopoeia, Part II), and it has the maximum absorption at a wavelength of 250nm.
(2) The infrared light absorption spectrum of this product should be consistent with the reference spectrum (Figure 1227 of "Infrared Spectroscopy Collection of Pharmaceuticals").
Check
Acidity
Take 0.10g of this product, add 25ml of water, shake thoroughly for 10 minutes, filter, take the filtrate, and determine it according to the method (Appendix VI H of the 2010 Edition of the Pharmacopoeia, Part II). The pH value should be 3.0 to 4.5.

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