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PHR1601

Valacyclovir HCl

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Valacyclovir hydrochloride

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About This Item

Empirical Formula (Hill Notation):
C13H20N6O4 · HCl
CAS Number:
124832-27-5
Molecular Weight:
360.80
NACRES:
NA.24
PubChem Substance ID:
329823501
UNSPSC Code:
41116107
MDL number:
MFCD01861507

Key Documents

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Product Name

Valacyclovir HCl, Pharmaceutical Secondary Standard; Certified Reference Material

InChI

1S/C13H20N6O4.ClH/c1-7(2)8(14)12(21)23-4-3-22-6-19-5-16-9-10(19)17-13(15)18-11(9)20;/h5,7-8H,3-4,6,14H2,1-2H3,(H3,15,17,18,20);1H/t8-;/m0./s1

SMILES string

Cl.CC(C)[C@H](N)C(=O)OCCOCn1cnc2C(=O)NC(N)=Nc12

InChI key

ZCDDBUOENGJMLV-QRPNPIFTSA-N

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0000834
traceable to USP 1707839

API family

valacyclovir

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

Quality Level

300

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Analysis Note

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

Application

It was used as reference standard for the quantification of valayclovir and its metabolite, from human plasma using LC/ESI-MS method.
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.
Valacyclovir HCl may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using spectrophotometric technique and reversed-phase high-performance liquid chromatography technique.

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.
Valacyclovir HCl is the hydrochloride salt of L-valyl ester, a prodrug of the antiviral drug acyclovir. Its mode of action involves the inhibition of the viral DNA polymerase and the termination of the viral DNA chain.It is widely used against herpes zoster, herpes simplex and herpes B.
Valacyclovir is a prodrug of acyclovir. It is an L-valyl ester and works against herpes simplex virus type and varicella zoster virus.

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.
To see an example of a Certificate of Analysis for this material enter LRAC3707 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Exclamation mark
GHS07

signalword

Warning

hcodes

H302

Hazard Classifications

Acute Tox. 4 Oral

Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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UV spectrophotometric method for the estimation of valacyclovir hcl in tablet dosage form
Ganesh.M, et al.
Journal of Chemistry, 6(3), 814-818 (2009)
Method development and validation of valacyclovir hydrochloride assay by RP?HPLC in pharmaceutical dosage forms
Bandla J and Gorja A
INTERNATIONAL JOURNAL OF ADVANCED RESEARCH IN BIOLOGICAL SCIENCES, 3(3), 33-41 (2013)
UV spectrophotometric method for the estimation of valacyclovir hcl in tablet dosage form.
Ganesh, M., et al.
Journal of Chemistry, 6.3, 814-818 (2009)
Selective and rapid liquid chromatography/negative-ion electrospray ionization mass spectrometry method for the quantification of valacyclovir and its metabolite in human plasma.
Kasiari M
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 864(1-2), 78-86 (2008)

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