PHR1626

Valganciclovir Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Valganciclovir hydrochloride hydrate, 2-[(2-amino-6-oxo-6,9-dihydro-3H-purin-9-yl)methoxy]-3-hydroxypropyl (2S)-2-amino-3-methylbutanoate hydrochloride hydrate, L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride hydrate
• Empirical Formula (Hill Notation): C₁₄H₂₂N₆O₅·HCl · xH₂O
• CAS Number: 175865-59-5
• Molecular Weight: 390.82 (anhydrous basis)
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to USP 1708004
• API family: valganciclovir
• CofA: current certificate can be downloaded
• packaging: pkg of 1 g
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• SMILES string: O.Cl.CC(C)[C@H](N)C(=O)OCC(CO)OCn1cnc2C(=O)N=C(N)Nc12
• InChI: 1S/C14H22N6O5.ClH.H2O/c1-7(2)9(15)13(23)24-4-8(3-21)25-6-20-5-17-10-11(20)18-14(16)19-12(10)22;;/h5,7-9,21H,3-4,6,15H2,1-2H3,(H3,16,18,19,22);1H;1H2/t8?,9-;;/m0../s1
• InChI key: XASVRRIYQZVANH-AHBBCRTASA-N

Description

General description

Valganciclovir Hydrochloride is the L-valyl ester of ganciclovir and an antiviral drug, widely used to treat cytomegalovirus infections.

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

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.

Valganciclovir Hydrochloride may be used as a secondary pharma standard for the quantification of the analyte in pharmaceutical formulations using liquid chromatography technique.

Biochem/physiol Actions

Valganciclovir hydrochloride hydrate is an antiviral used to treat cytomegalovirus infection. It is the prodrug of ganciclovir, a synthetic analog of 2′-deoxy-guanosine which is phosphorylated to a dGTP analog that competitively inhibits the incorporation of dGTP by viral DNA polymerase.

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 LRAA5295 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable