PHR1876

Valsartan Related Compound B

Pharmaceutical Secondary Standard; Certified Reference Material

• 別名: 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
• 実験式（ヒル表記法）: C₂₃H₂₇N₅O₃
• CAS番号: 952652-79-8
• 分子量: 421.49
• MDL番号: MFCD19689078
• UNSPSCコード: 41116107
• NACRES: NA.24

特性

• グレード: certified reference material; pharmaceutical secondary standard
• 品質水準: 300
• 認証: traceable to USP 1708784
• APIファミリー: valsartan
• CofA: current certificate can be downloaded
• 包装: pkg of 30 mg
• アプリケーション: pharmaceutical
• フォーマット: neat
• 保管温度: 2-8°C
• SMILES記法: 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 Key: OKAQHVJSXLGXET-NRFANRHFSA-N

詳細

詳細

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.

アプリケーション

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

アナリシスノート

このような2次標準は、入手可能な場合にはUSP、EP、BPの1次標準にマルチトレーサビリティを提供します。

脚注

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.

安全性情報

• ピクトグラム: GHS08,GHS07
• シグナルワード: Warning
• 危険有害性情報: H336,H361d
• 注意書き: P202 - P261 - P271 - P280 - P304 + P340 + P312 - P308 + P313
• 危険有害性の分類: Repr. 2 - STOT SE 3
• ターゲットの組織: Central nervous system
• 保管分類コード: 11 - Combustible Solids
• WGK: WGK 3
• 引火点(°F): Not applicable
• 引火点(℃): Not applicable