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Merck
모든 사진(1)

주요 문서

PHR1616

Supelco

Granisetron Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

동의어(들):

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

실험식(Hill 표기법):
C18H24N4O· HCl
CAS Number:
Molecular Weight:
348.87
MDL number:
UNSPSC 코드:
41116107
PubChem Substance ID:
NACRES:
NA.24

Grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to Ph. Eur. Y0000396
traceable to USP 1298106

API family

granisetron

CofA

current certificate can be downloaded

포장

pkg of 500 mg

기술

HPLC: suitable
gas chromatography (GC): suitable

응용 분야

pharmaceutical (small molecule)

형식

neat

저장 온도

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-;

InChI key

QYZRTBKYBJRGJB-WQTKJZBYSA-N

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일반 설명

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.

애플리케이션

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.

생화학적/생리학적 작용

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

분석 메모

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

기타 정보

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.

각주

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.

픽토그램

Exclamation mark

신호어

Warning

유해 및 위험 성명서

Hazard Classifications

Acute Tox. 4 Oral

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point (°F)

Not applicable

Flash Point (°C)

Not applicable


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시험 성적서(COA)

Lot/Batch Number

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문서 라이브러리 방문

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)
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)
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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