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Key Documents

PHR1324

Supelco

N-metil-D-glucamina

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):

1-Desoxi-1-(metilamino)-D-glucitol, Meglumina

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About This Item

Fórmula empírica (Notação de Hill):
C7H17NO5
Número CAS:
Peso molecular:
195.21
Beilstein:
385906
Número CE:
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. Y0001209
traceable to USP 1379140

família API

meglumine

Certificado de análise (CofA)

current certificate can be downloaded

temperatura de autoignição

~662 °F

técnica(s)

HPLC: suitable
gas chromatography (GC): suitable

pf

129-131.5 °C (lit.)

aplicação(ões)

pharmaceutical (small molecule)

formato

neat

temperatura de armazenamento

2-30°C

cadeia de caracteres SMILES

CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO

InChI

1S/C7H17NO5/c1-8-2-4(10)6(12)7(13)5(11)3-9/h4-13H,2-3H2,1H3/t4-,5+,6+,7+/m0/s1

chave InChI

MBBZMMPHUWSWHV-BDVNFPICSA-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.
Meglumine is a glucose-derived secondary amine which is widely used as an excipient in pharmaceutical formulations.

Aplicação

Meglumine 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.

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 LRAC3472 in the slot below. This is an example certificate only and may not be the lot that you receive.

Código de classe de armazenamento

11 - Combustible Solids

Classe de risco de água (WGK)

WGK 1

Ponto de fulgor (°F)

Not applicable

Ponto de fulgor (°C)

Not applicable


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Simultaneous determination of positive and negative pharmaceutical counterions using mixed-mode chromatography coupled with charged aerosol detector
Zhang K, et al.
Journal of Chromatography A, 1217(37), 5776-5784 (2010)
Development and validation of a new HPLC-MS method for meglumine impurity profiling
Martano C, et al.
Journal of Pharmaceutical and Biomedical Analysis, 149(37), 517-524 (2018)
M Parant et al.
Ecotoxicology and environmental safety, 182, 109385-109385 (2019-07-02)
The present study was the first approach conducted under environmental concentrations of Gd-DOTA and Gd-DTPA-BMA to assess cellular impacts of these compounds. Gd-DOTA (Gadoteric acid) is one of the most stable contrast agent, currently used as Dotarem® formulation during Magnetic
Lourens F H J Robbers et al.
Radiology, 272(1), 113-122 (2014-03-13)
To investigate the effects of cell therapy on myocardial perfusion recovery after treatment of acute myocardial infarction (MI) with primary percutaneous coronary intervention (PCI). In this HEBE trial substudy, which was approved by the institutional review board (trial registry number
Hubert Cochet et al.
Radiology, 271(1), 239-247 (2014-01-31)
To demonstrate the feasibility of comprehensive assessment of cardiac arrhythmias by combining body surface electrocardiographic (ECG) mapping (BSM) and imaging. This study was approved by the institutional review board, and all patients gave written informed consent. Twenty-seven patients referred for

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