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PHR1616

Granisetron Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Granisetron hydrochloride, 1-Methyl-N-[(3-endo)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide hydrochloride

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About This Item

Empirical Formula (Hill Notation):
C18H24N4O· HCl
CAS Number:
107007-99-8
Molecular Weight:
348.87
NACRES:
NA.24
PubChem Substance ID:
329823512
UNSPSC Code:
41116107
MDL number:
MFCD01747034

Key Documents

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Product Name

Granisetron Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

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-;

SMILES string

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

InChI key

QYZRTBKYBJRGJB-WQTKJZBYSA-N

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0000396
traceable to USP 1298106

description

Drug Control: Kábítószer / Narcotic Drug (Hungary), 78/2022. (XII. 28.) BM rendelet

API family

granisetron

CofA

current certificate can be downloaded

packaging

pkg of 500 mg

drug control

Kábítószer / Narcotic Drug (Hungary), 78/2022. (XII. 28.) BM rendelet

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

Quality Level

300

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Analysis Note

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

Application

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 Actions

Granisetron hydrochloride is a serotonin 5-HT3 receptor antagonist and antiemetic.

General description

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.

Other Notes

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.
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.

pictograms

Exclamation mark
GHS07

signalword

Warning

hcodes

H302

Hazard Classifications

Acute Tox. 4 Oral

Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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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