PHR1601

Valacyclovir HCl

Pharmaceutical Secondary Standard; Certified Reference Material

• 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

Properties

• 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

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.
Valacyclovir HCl is the hydrochloride salt of L-valyl ester, a prodrug of the antiviral drug acyclovir.[1][2] 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.[1]

Valacyclovir is a prodrug of acyclovir. It is an L-valyl ester and works against herpes simplex virus type and varicella zoster virus.[3]

Application

It was used as reference standard for the quantification of valayclovir and its metabolite, from human plasma using LC/ESI-MS method.[4]

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[1][2] using spectrophotometric technique[1] and reversed-phase high-performance liquid chromatography technique.[2]

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.

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H302
• Precautionary Statements: P264 - P270 - P301 + P312 - P501
• Hazard Classifications: Acute Tox. 4 Oral
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable