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PHR1601

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Valacyclovir HCl

Pharmaceutical Secondary Standard; Certified Reference Material

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

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

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

SMILES string

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

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

InChI key

ZCDDBUOENGJMLV-QRPNPIFTSA-N

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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
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.

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.

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 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

Signal Word

Warning

Hazard Statements

H302

Precautionary Statements

P264 - P270 - P301 + P312 - P501

Hazard Classifications

Acute Tox. 4 Oral

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)
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)
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)

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