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Key Documents

PHR1593

Supelco

Ganciclovir

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(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

Fórmula empírica (Notação de Hill):
C9H13N5O4
Número CAS:
Peso molecular:
255.23
Número MDL:
Código UNSPSC:
41116107
ID de substância PubChem:
NACRES:
NA.24

grau

certified reference material
pharmaceutical secondary standard

Nível de qualidade

Agency

traceable to Ph. Eur. Y0001129
traceable to USP 1288306

família API

ganciclovir

Certificado de análise (CofA)

current certificate can be downloaded

embalagem

pkg of 1 g

técnica(s)

HPLC: suitable
gas chromatography (GC): suitable

aplicação(ões)

pharmaceutical (small molecule)

formato

neat

temperatura de armazenamento

2-8°C

cadeia de caracteres 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)

chave InChI

IRSCQMHQWWYFCW-UHFFFAOYSA-N

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Descrição geral

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.

Aplicação

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.

Nota de análise

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

Outras notas

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.

Nota de rodapé

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.

Produtos recomendados

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.

Pictogramas

Health hazard

Palavra indicadora

Danger

Frases de perigo

Declarações de precaução

Classificações de perigo

Muta. 1B - Repr. 2

Código de classe de armazenamento

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

Classe de risco de água (WGK)

WGK 3

Ponto de fulgor (°F)

Not applicable

Ponto de fulgor (°C)

Not applicable


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Certificados de análise (COA)

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Aciclovir European Pharmacopoeia (EP) Reference Standard

A0220000

Aciclovir

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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