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Solubilizers Meglumine Powder CAS-6284-40-8 Methylglucamine Yellowish White

Minimum Order Quantity : 25kg Price : to be negotiated
Packaging Details : 25kg in a fiber drum Delivery Time : propmt upon payment done
Payment Terms : T/T, L/C Supply Ability : shipped to worldwide
Place of Origin: China Brand Name: LIBANG
Certification: Chinese GMP Model Number: USP

Detail Information

Dossier: GMP, DML. DMF Batch Size: 500kg
Stock: 2000kgs Quality Specification: USP, EP, CP
Capicity: 6000kgs Per Month Certi: China GMP
High Light:

Solubilizers Meglumine Powder

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Meglumine Powder CAS-6284-40-8

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CAS-6284-40-8 Methylglucamine powder

Product Description

Meglumine USP EP CP Solubilizers N-methyl-glucamine CAS-6284-40-8

 

Meglumine is a sugar alcohol derived from glucose that contains an amino group modification. It is often used as an excipient in pharmaceuticals and in conjunction with iodinated compounds in contrast media such as diatrizoate meglumine, iothalamate meglumine and iodipamide meglumine.

 

GENERAL PROPERTIES

Description

White or almost white, crystalline powder (CP); White to faintly yellowish-white, odorless crystals or powder (USP).

Solubility

Freely soluble in water; sparingly soluble in alcohol, practically insoluble in chloroform (CP); Freely soluble in water; sparingly soluble in alcohol (USP).

The trial production was started from Jun. 2002, and in Jan. 2003, the pilot production has been developed and finally in Sep. 2003, the commercial production has been started.

During R&D stage, all the critical parameters were challenged and an acceptance criteria was defined for every in process control test.

Validated process control has been described in SOP and batch record. Operators have been trained to manufacture qualified product as per SOP.

 

Item Specification USP
Appearance White to faintly yellowish-white, odorless crystals or powder
Solubility Freely soluble in water; sparingly soluble in alcohol
Identification Positive reaction
Completeness and color of solution The solution should be clear, and the absorbance at 420nm should be not greater than 0.030.
Melting range 128°C~132°C
Specific rotation -15.7°~-17.3°
Loss on drying ≤1.0%
Residue on ignition ≤0.1%
Heavy metals ≤0.002%
Absence of reducing substances The color of the solution does not change
*Residual solvents Ethanol≤0.5%
Assay It contains 99.0%-100.5% of C7H17NO5, calculated on dried basis.
 

There are no critical changes in the manufacturing process.

The quality specification as per USP is displayed as follow:

 

Solubilizers Meglumine Powder CAS-6284-40-8 Methylglucamine Yellowish White 0
 

Solubilizers Meglumine Powder CAS-6284-40-8 Methylglucamine Yellowish White 1

 

 

 

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