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PHR1324

Supelco

Meglumine

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
N-Methyl-D-glucamine, 1-Deoxy-1-(methylamino)-D-glucitol, Meglumine
Empirical Formula (Hill Notation):
C7H17NO5
CAS Number:
Molecular Weight:
195.21
Beilstein:
385906
EC Number:
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

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

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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.

Footnote

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.

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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Development and validation of a new HPLC-MS method for meglumine impurity profiling
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