PHR1875

Valsartan Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): D-Valsartan, N-VALERYL-N-{[2’-(1HTETRAZOLE-5-YL)-BIPHENYL-4-YL]-METHYL}-D-VALINE(ent-Valsartan), (R)-N-Valeryl-N-([2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]methyl)valine, N-(1-Oxopentyl)-N-[[2′-(2H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-D-valine
• Empirical Formula (Hill Notation): C₂₄H₂₉N₅O₃
• Molecular Weight: 435.52
• MDL number: MFCD18252868
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to USP 1708773
• API family: valsartan
• CofA: current certificate can be downloaded
• packaging: pkg of 30 mg
• 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-/m1/s1
• InChI key: ACWBQPMHZXGDFX-JOCHJYFZSA-N

Description

General description

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. Valsartan Related Compound A is an impurity of valsartan, an orally active specific angiotensin II receptor blocker or angiotensin-II antagonist, which is widely used in treating hypertension by lowering the blood pressure.

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 tablet formulations, bulk and pharmaceutical dosage forms using reversed-phase high-performance liquid chromatography technique.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP 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 LRAB1041 in the Documents 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: 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