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Key Documents

PHR1593

Supelco

Ganciclovir

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

Ganciclovir, GNC, 2-Amino-1,9-dihydro-9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]-6H-purin-6-one, 9-(1,3-Dihydroxy-2-propoxymethyl)guanine, DHPG

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About This Item

Formule empirique (notation de Hill):
C9H13N5O4
Numéro CAS:
Poids moléculaire :
255.23
Numéro MDL:
Code UNSPSC :
41116107
ID de substance PubChem :
Nomenclature NACRES :
NA.24

Qualité

certified reference material
pharmaceutical secondary standard

Niveau de qualité

Agence

traceable to Ph. Eur. Y0001129
traceable to USP 1288306

Famille d'API

ganciclovir

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 

NC1=Nc2c(ncn2COC(CO)CO)C(=O)N1

InChI

1S/C9H13N5O4/c10-9-12-7-6(8(17)13-9)11-3-14(7)4-18-5(1-15)2-16/h3,5,15-16H,1-2,4H2,(H3,10,12,13,17)

Clé InChI

IRSCQMHQWWYFCW-UHFFFAOYSA-N

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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.
Ganciclovir is a nucleoside analog which is utilized extensively for the remedy of cytomegalovirus infections. It is also found to be efficient in the treatment of cytomegalovirus in immunocompromised patients, particularly against acquired immunodeficiency syndrome (AIDS) and congenital immunodeficiency.

Application

Ganciclovir may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography techniques.
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.

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 LRAB3691 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Produits recommandés

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Pictogrammes

Health hazard

Mention d'avertissement

Danger

Mentions de danger

Conseils de prudence

Classification des risques

Muta. 1B - Repr. 2

Code de la classe de stockage

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

Classe de danger pour l'eau (WGK)

WGK 3

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


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Certificats d'analyse (COA)

Lot/Batch Number

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Retrouvez la documentation relative aux produits que vous avez récemment achetés dans la Bibliothèque de documents.

Consulter la Bibliothèque de documents

Stability of ganciclovir in extemporaneously compounded oral liquids.
Anaizi NH, et al.
American Journal of Health-System Pharmacy, 56(17), 1738-1741 (1999)
Development and Validation of RP-HPLC Method for the Determination of Ganciclovir in Bulk Drug and in Formulations.
Ramesh PJ, et al.
ISRN Chromatography (2012)

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