PHR1315

Valsartan

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Valsartan, N-(1-Oxopentyl)-N-[[2′-(2H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-valine
• Empirical Formula (Hill Notation): C₂₄H₂₉N₅O₃
• CAS Number: 137862-53-4
• Molecular Weight: 435.52
• MDL number: MFCD00865840
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823301
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to BP 1161; traceable to Ph. Eur. Y0001132; traceable to USP 1708762
• API family: valsartan
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• SMILES string: CCCCC(=O)N(Cc1ccc(cc1)-c2ccccc2-c3nnn[nH]3)[C@@H](C(C)C)C(O)=O
• InChI: 1S/C24H29N5O3/c1-4-5-10-21(30)29(22(16(2)3)24(31)32)15-17-11-13-18(14-12-17)19-8-6-7-9-20(19)23-25-27-28-26-23/h6-9,11-14,16,22H,4-5,10,15H2,1-3H3,(H,31,32)(H,25,26,27,28)/t22-/m0/s1
• InChI key: ACWBQPMHZXGDFX-QFIPXVFZSA-N
• Gene Information: human ... AGTR1(185)

Description

General description

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to pharmacopeia primary standards.

Valsartan is an orally active specific angiotensin II receptor blocker used for the treatment of hypertension.[1][2]

Application

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Valsartan may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography[1][3][2] and spectrophotometry.[4]

Analysis Note

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

Other Notes

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.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC2970 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• pictograms: GHS08,GHS07
• signalword: Warning
• hcodes: H336,H361d
• pcodes: P201 - 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