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PHR1626

Supelco

Valganciclovir Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

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

Quality Level

grade

certified reference material
pharmaceutical secondary standard

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

pharmacopeia traceability

traceable to USP 1708004

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

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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 pharmacopeia primary 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.

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Stability indicating liquid chromatographic method for the quantitative determination of valganciclovir in pharmaceutical dosage forms
Annapurna MM, et al.
Journal of Drug Delivery and Therapeutics, 3(3), 64-70 (2013)
Victor M Luna et al.
Science (New York, N.Y.), 364(6440), 578-583 (2019-05-11)
Young adult-born granule cells (abGCs) in the dentate gyrus (DG) have a profound impact on cognition and mood. However, it remains unclear how abGCs distinctively contribute to local DG information processing. We found that the actions of abGCs in the

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