CP N Methyl D Glucamine White Crystalline Powder Gadoterate Meglumine
Contact Person : Jimmy Tian
Phone Number : 86-18602905046
WhatsApp : +8618602905046
| Minimum Order Quantity : | 25kg | Packaging Details : | 25kg in a fiber drum |
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| Delivery Time : | 7 Working days | Payment Terms : | T/T, L/C |
| Supply Ability : | 50000 kg per year |
| Place of Origin: | China | Brand Name: | LIBANG |
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| Certification: | Chinese GMP |
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Detail Information |
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| Dossier: | DMF Available | Batch Size: | 500kg |
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| HS Code: | 2924.2990 99 | Quality Specification: | USP, EP, CP |
| Delivery: | Prompt | Origin: | China |
| High Light: | USP Meglumine Gadoterate Powder,Meglumine Gadoterate Powder CAS-6284-40-8,CAS-6284-40-8 N Methyl Glucamine |
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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. |
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| Xi'an Libang Pharmaceutical Co., Ltd. |
| 17/F, Block E, Wangzuo International Plaza, No.1, Tangyan Road, Xi’an Hi-tech Zone, Shaanxi, P.R.China 710075 |
| 86-29-89527363 |
| jiangping@libang.com.cn |