PHR1876

N-(1-Oxobutil)-N-[[2′-(2H-tetrazol-5-il)[1,1′-bifenil]-4-il]metil]-L-valina

Pharmaceutical Secondary Standard; Certified Reference Material

• Sinónimos: (S)-N-butiril-N-{[2′-(1-H-tetrazol-5-il)-bifenil-4-il]metil}valina
• Fórmula empírica (notación de Hill): C₂₃H₂₇N₅O₃
• Número de CAS: 952652-79-8
• Peso molecular: 421.49
• MDL number: MFCD19689078
• UNSPSC Code: 41116107
• NACRES: NA.24

Propiedades

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to USP 1708784
• API family: valsartan
• CofA: current certificate can be downloaded
• packaging: pkg of 30 mg
• application(s): pharmaceutical
• format: neat
• storage temp.: 2-8°C
• SMILES string: 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

Descripción

General description

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.

Application

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

Analysis Note

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

Footnote

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.

Información de seguridad

• pictograms: GHS08,GHS07
• signalword: Warning
• hcodes: H336,H361d
• pcodes: P202 - P261 - P271 - P280 - P304 + P340 + P312 - P308 + P313
• Hazard Classifications: Repr. 2 - STOT SE 3
• target_organs: Central nervous system
• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable