1.06143
Meglumine
low in endotoxins, EMPROVE® API, Ph. Eur., ChP, JP, USP
Synonym(s):
N-Methyl-D-glucamine, 1-Deoxy-1-methylaminosorbitol, 1-Deoxy-1-(methylamino)-D-glucitol, Meglumine
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About This Item
Quality Level
agency
ChP, JP, Ph. Eur., USP
product line
EMPROVE® API
form
extra fine powder, solid
autoignition temp.
~662 °F
potency
>5000 mg/kg LD50, oral (Rat)
technique(s)
API processing | salt formation: suitable
pH
11 (20 °C, 10 g/L in H2O)
bp
210 °C/1013 hPa (decomposes)
mp
129-131.5 °C (lit.)
application(s)
liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical
solid formulation
solubility enhancement
storage temp.
no temp limit
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
As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.
Application
Meglumine Emprove® API is manufactured according to ICH Q7 guidelines.
Legal Information
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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Articles
Discover strategies to enhance solubility in injectable formulations using excipients, including cyclodextrins, meglumine, and polyethylene glycols.
Instead of addressing API solubility during formulation, tackle it early during development. Read about the various methods for API processing.
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Global Trade Item Number
| SKU | GTIN |
|---|---|
| 1061431000 | 04022536073262 |
| 1061439029 | 04022536556796 |
| 1061439030 | 04022536631479 |
| 1061439025 | 04022536073279 |
| 1061439050 | 04022536585086 |
| 1061439026 | 04022536938639 |
| 1061430001 | 04054839016783 |
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