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PHR1324

Meglumine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

N-Methyl-D-glucamine, 1-Deoxy-1-(methylamino)-D-glucitol, Meglumine

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About This Item

Empirical Formula (Hill Notation):
C7H17NO5
CAS Number:
6284-40-8
Molecular Weight:
195.21
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823309
EC Number:
228-506-9
Beilstein/REAXYS Number:
385906
MDL number:
MFCD00004707

Key Documents

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Product Name

Meglumine, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

MBBZMMPHUWSWHV-BDVNFPICSA-N

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

SMILES string

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

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

Quality Level

300

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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.

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.

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.

Storage Class

11 - Combustible Solids

wgk

WGK 1

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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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
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
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
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