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PHR1324

N-Méthyle-D-glucamine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

1-Désoxy-1-(méthylamino)-D-glucitol, Méglumine

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A propos de cet article

Formule empirique (notation de Hill) :
C7H17NO5
Numéro CAS:
6284-40-8
Poids moléculaire :
195.21
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823309
EC Number:
228-506-9
Beilstein/REAXYS Number:
385906
MDL number:
MFCD00004707
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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0001209, traceable to USP 1379140

API family

meglumine

CofA

current certificate can be downloaded

autoignition temp.

~662 °F

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

mp

129-131.5 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

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

InChI key

MBBZMMPHUWSWHV-BDVNFPICSA-N

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

Application

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.

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

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Classe de stockage

11 - Combustible Solids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificats d'analyse (COA)

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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
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Numéro d'article de commerce international

RéférenceGTIN
PHR1324-1G04061834415947