PHR1601

Valacyclovir HCl

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : Valacyclovir hydrochloride
• Formule empirique (notation de Hill): C₁₃H₂₀N₆O₄ · HCl
• Numéro CAS: 124832-27-5
• Poids moléculaire : 360.80
• Numéro MDL: MFCD01861507
• Code UNSPSC : 41116107
• ID de substance PubChem : 329823501
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to Ph. Eur. Y0000834; traceable to USP 1707839
• Famille d'API: valacyclovir
• CofA (certificat d'analyse): current certificate can be downloaded
• Conditionnement: pkg of 1 g
• Technique(s): HPLC: suitable; gas chromatography (GC): suitable
• Application(s): pharmaceutical (small molecule)
• Format: neat
• Température de stockage: 2-8°C
• Chaîne SMILES: 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
• Clé InChI: ZCDDBUOENGJMLV-QRPNPIFTSA-N

Description

Description générale

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.

Remarque sur l'analyse

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

Autres remarques

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.

Note de bas de page

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.

Informations sur la sécurité

• Pictogrammes: GHS07
• Mention d'avertissement: Warning
• Mentions de danger: H302
• Conseils de prudence: P264 - P270 - P301 + P312 - P501
• Classification des risques: Acute Tox. 4 Oral
• Code de la classe de stockage: 11 - Combustible Solids
• Classe de danger pour l'eau (WGK): WGK 3
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable