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PHR1616

Supelco

Granisetron -hydrochlorid

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(e):

1-Methyl-N-[(3-endo)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazol-3-carboxamid -hydrochlorid

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About This Item

Empirische Formel (Hill-System):
C18H24N4O· HCl
CAS-Nummer:
Molekulargewicht:
348.87
MDL-Nummer:
UNSPSC-Code:
41116107
PubChem Substanz-ID:
NACRES:
NA.24

Qualität

certified reference material
pharmaceutical secondary standard

Qualitätsniveau

Agentur

traceable to Ph. Eur. Y0000396
traceable to USP 1298106

API-Familie

granisetron

Analysenzertifikat (CofA)

current certificate can be downloaded

Verpackung

pkg of 500 mg

Methode(n)

HPLC: suitable
gas chromatography (GC): suitable

Anwendung(en)

pharmaceutical (small molecule)

Format

neat

Lagertemp.

2-30°C

SMILES String

Cl.CN1[C@H]2CCC[C@@H]1C[C@@H](C2)NC(=O)c3nn(C)c4ccccc34

InChI

1S/C18H24N4O.ClH/c1-21-13-6-5-7-14(21)11-12(10-13)19-18(23)17-15-8-3-4-9-16(15)22(2)20-17;/h3-4,8-9,12-14H,5-7,10-11H2,1-2H3,(H,19,23);1H/t12-,13+,14-;

InChIKey

QYZRTBKYBJRGJB-WQTKJZBYSA-N

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Allgemeine Beschreibung

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.

Anwendung

Granisetron Hydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations, and human plasma samples employed in bioequivalence studies by various 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.

Biochem./physiol. Wirkung

Granisetron-hydrochlorid ist ein Serotonin-5-HT3-Rezeptorantagonist und ein Antiemetikum.

Hinweis zur Analyse

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

Sonstige Hinweise

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.

Fußnote

To see an example of a Certificate of Analysis for this material enter LRAA4875 in the slot below. This is an example certificate only and may not be the lot that you receive.

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Piktogramme

Exclamation mark

Signalwort

Warning

H-Sätze

Gefahreneinstufungen

Acute Tox. 4 Oral

Lagerklassenschlüssel

11 - Combustible Solids

WGK

WGK 3

Flammpunkt (°F)

Not applicable

Flammpunkt (°C)

Not applicable


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Analysenzertifikate (COA)

Lot/Batch Number

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Ondansetronhydrochlorid United States Pharmacopeia (USP) Reference Standard

USP

1478582

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PHR1619

Beclomethasondipropionat

17α-Methyltestosteron solid (photosensitive)

Sigma-Aldrich

M7252

17α-Methyltestosteron

Diphenhydramin -hydrochlorid Pharmaceutical Secondary Standard; Certified Reference Material

Supelco

PHR1015

Diphenhydramin -hydrochlorid

Rapid determination of granisetron in human plasma by liquid chromatography coupled to tandem mass spectrometry and its application to bioequivalence study.
Jiang Y, et al.
Journal of Pharmaceutical and Biomedical Analysis, 42(4), 464-473 (2006)
Stability-indicating HPLC-DAD method for the determination of Granisetron hydrochloride in its pharmaceutical preparations.
Mabrouk M, et al.
Journal of Applied Pharmaceutical Science, 3(6), 189-189 (2013)
Ismail Hewala et al.
Journal of AOAC International, 94(5), 1447-1460 (2011-12-15)
A simple, rapid, and sensitive RP-HPLC method using photodiode array detection was developed and validated for the simultaneous determination of granisetron hydrochloride, 1-methyl-1H-indazole-3-carboxylic acid (the main degradation product of granisetron), sodium benzoate, methylparaben, propylparaben, and 4-hydroxybenzoic acid (the main degradation

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