PHR1876

缬沙坦相关化合物B

Pharmaceutical Secondary Standard; Certified Reference Material

• 同義詞: N-(1-Oxobutyl)-N-[[2′-(2H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-valine, N-butyryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]methyl}-L-valine, (S)-N-Butyryl-N-{[2′-(1-H-tetrazole-5-yl)-biphenyl-4-yl]methyl}valine
• 經驗公式（希爾表示法）: C₂₃H₂₇N₅O₃
• CAS號碼: 952652-79-8
• 分子量：: 421.49
• MDL號碼: MFCD19689078
• 分類程式碼代碼: 41116107
• NACRES: NA.24

屬性

• 等級: certified reference material; pharmaceutical secondary standard
• 品質等級: 300
• agency: traceable to USP 1708784
• API 家族: valsartan
• CofA: current certificate can be downloaded
• 包裝: pkg of 30 mg
• 應用: pharmaceutical
• 形式: neat
• 儲存溫度: 2-8°C
• SMILES 字串: CCCC(=O)N(Cc1ccc(cc1)-c2ccccc2-c3nnn[nH]3)[C@@H](C(C)C)C(O)=O
• InChI: 1S/C23H27N5O3/c1-4-7-20(29)28(21(15(2)3)23(30)31)14-16-10-12-17(13-11-16)18-8-5-6-9-19(18)22-24-26-27-25-22/h5-6,8-13,15,21H,4,7,14H2,1-3H3,(H,30,31)(H,24,25,26,27)/t21-/m0/s1
• InChI 密鑰: OKAQHVJSXLGXET-NRFANRHFSA-N

描述

一般說明

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

It is an impurity of the potent, highly selective, and orally active antagonist of the angiotensin II AT1-receptor, valsartan, used widely for the treatment of hypertension.

應用

This pharmaceutical secondary standard can also be used as follows:

• Development of a reversed-phase high-performance liquid chromatographic (RP-HPLC) method for the determination of valsartan and its related impurities in pharmaceutical dosage forms
• Impurity testing of valsartan, amlodipine besylate, and hydrochlorothiazide in their combined dosage form by a stability-indicating ultra-high performance liquid chromatography (UHPLC)
• Simultaneous determination of amlodipine and valsartan in their combined dosage form, in the presence of their degradation products by a gradient reversed phase-liquid chromatographic (RP-LC) method
• Separation and detection of nitrosamines and other related impurities in valsartan and losartan using supercritical fluid chromatography (SFC) in a single run
• Development and validation of a UHPLC method for the estimation of sacubitril, valsartan, and their related impurities in their combined dosage form, following ICH Q2 (R1) guideline

分析報告

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

腳註

To see an example of a Certificate of Analysis for this material enter LRAB1042 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

安全資訊

• 象形圖: GHS08,GHS07
• 訊號詞: Warning
• 危險聲明: H336,H361d
• 防範說明: P202 - P261 - P271 - P280 - P304 + P340 + P312 - P308 + P313
• 危險分類: Repr. 2 - STOT SE 3
• 標靶器官: Central nervous system
• 儲存類別代碼: 11 - Combustible Solids
• 水污染物質分類（WGK）: WGK 3
• 閃點（°F）: Not applicable
• 閃點（°C）: Not applicable