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Amlodipine Base
Bulk Drug Intermediate used for Pharmaceutical Pourpose and followings are the Specifications
Sr.No. Test Specifications
1 Description All most White Coloured Powder
2 Water Solubility not more than 1.0 %
3 Purity by HPLC Not less than 98.0 %
4 Solubility Soluble in Methanol, insoluble in water
5 Assay by HPLC 98.0 % to 102 %
6 Packing 5.0, 10.0, 25.0, 50.0 kg with double
polythene bags in fibre drum.
7 Storage Store in tightly closed container at 25 to
30 ' C
Product Name
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Amlodipine Base
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Mol. Wt.
|
408.50
|
Formula
|
C20H25CLN2O5
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Technical Specification
S. No.
|
Test
|
Specificaiton
|
01
|
Descriptions
|
All most white coloured powder
|
02
|
Water
|
Not more than 1.0%
|
03
|
M.P.
|
|
04
|
Purity by HPLC
|
Not less than 98.0% |
05
|
Solubility
|
Soluble in Methanol, in sohible in water |
06
|
Assay by HPLC
|
98.0 - 102% |
07
|
Packing
|
5.0, 10.0, 25.0, 50.0 kg withy double
polythene bags in fiber drum |
08
|
Storage
|
Store in tightly closed container at 25
to 30oC
|
Prepared by
|
QC Officer
|
Date:
|
Approved by
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QC In charge
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24/04/2006
|
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