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| Brand Name: | LIBANG |
| Model Number: | USP |
| MOQ: | 25kg |
| Price: | to be negotiated |
| Payment Terms: | T/T, L/C |
| Supply Ability: | 50000 kg per year |
Meglumine USP EP 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.
| 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:
