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Documenti fondamentali

PHR1534

Supelco

Griseofulvin

Pharmaceutical Secondary Standard; Certified Reference Material

Sinonimo/i:

Griseofulvin, (2S)-trans-7-Chloro-2′,4,6-trimethoxy-6′-methylspiro(benzofuran-2[3H],1′-[2]cyclohexene)-3,4′-dione

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About This Item

Formula empirica (notazione di Hill):
C17H17ClO6
Numero CAS:
Peso molecolare:
352.77
Beilstein:
95226
Numero CE:
Numero MDL:
Codice UNSPSC:
41116107
ID PubChem:
NACRES:
NA.24

Grado

certified reference material
pharmaceutical secondary standard

Livello qualitativo

agenzia

traceable to BP 180
traceable to Ph. Eur. G0600000
traceable to USP 1299007

Famiglia di API

griseofulvin

CdA

current certificate can be downloaded

Confezionamento

pkg of 1 g

tecniche

HPLC: suitable
gas chromatography (GC): suitable

applicazioni

pharmaceutical (small molecule)

Formato

neat

Temperatura di conservazione

-10 to -25°C

Stringa SMILE

ClC1=C(O[C@@]2(C(OC)=CC(C[C@H]2C)=O)C3=O)C3=C(OC)C=C1OC

InChI

1S/C17H17ClO6/c1-8-5-9(19)6-12(23-4)17(8)16(20)13-10(21-2)7-11(22-3)14(18)15(13)24-17/h6-8H,5H2,1-4H3/t8-,17+/m1/s1
DDUHZTYCFQRHIY-RBHXEPJQSA-N

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Descrizione generale

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.

Applicazioni

Griseofulvin 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.

Risultati analitici

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

Altre note

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 a piè di pagina

To see an example of a Certificate of Analysis for this material enter LRAA3652 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pittogrammi

Health hazardExclamation mark

Avvertenze

Danger

Indicazioni di pericolo

Classi di pericolo

Carc. 2 - Repr. 1B - Skin Sens. 1

Codice della classe di stoccaggio

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

Classe di pericolosità dell'acqua (WGK)

WGK 3

Punto d’infiammabilità (°F)

Not applicable

Punto d’infiammabilità (°C)

Not applicable


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Certificati d'analisi (COA)

Lot/Batch Number

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High?perfrmance liquid chromatographic analysis of griseofulvin in drug substance and solid dosage forms: Separation of impurities and metabolites.
Townley E and Roden P
Journal of Pharmaceutical Sciences, 69(5), 523-526 (1980)
Oil-in-water microemulsion high performance liquid chromatographic analysis of pharmaceuticals.
Marsh A, et al.
Chromatographia, 59(9), 531-542 (2004)
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Journal of pharmaceutical sciences, 103(9), 2772-2783 (2013-12-12)
Pharmaceutical materials, crystalline and amorphous, sorb water from the atmosphere, which affects critical factors in the development of drugs, such as the selection of drug substance crystal form, compatibility with excipients, dosage form selection, packaging, and product shelf-life. It is
Damir Elmar Zecevic et al.
European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V, 87(2), 264-270 (2014-04-29)
Many upcoming drug candidates are pH-dependent poorly soluble weak bases in the pH range of the gastrointestinal tract. This often leads to a high in vivo variability and bioavailability issues. Aiming to overcome these limitations, the design of solid dispersions
Dipy M Vasa et al.
Journal of pharmaceutical sciences, 103(9), 2911-2923 (2014-05-16)
Fifteen model drugs were quenched from 3:1 (w/w) mixtures with polyethylene glycol 4000 (PEG4000). The resulting solids were characterized using powder X-ray diffraction (PXRD), analysis of pair distribution function-transformed PXRD data (where appropriate), hot-stage polarized light microscopy, and differential scanning

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