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USP Meglumine Gadoterate Powder CAS-6284-40-8 N Methyl Glucamine

Minimum Order Quantity : 25kg Packaging Details : 25kg in a fiber drum
Delivery Time : 7 Working days Payment Terms : T/T, L/C
Supply Ability : 50000 kg per year
Place of Origin: China Brand Name: LIBANG
Certification: Chinese GMP

Detail Information

Dossier: DMF Available Batch Size: 500kg
HS Code: 2924.2990 99 Quality Specification: USP, EP, CP
Delivery: Prompt Origin: China
High Light:

USP Meglumine Gadoterate Powder

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Meglumine Gadoterate Powder CAS-6284-40-8

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CAS-6284-40-8 N Methyl Glucamine

Product Description

Meglumine N-methyl-glucamine CAS-6284-40-8

 

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.

There are no critical changes in the manufacturing process.

The quality specification as per USP is displayed as follow:
 

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.

 

USP Meglumine Gadoterate Powder CAS-6284-40-8 N Methyl Glucamine 0

 

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