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CERTIFICATE OF ANALYSIS
Product name |
Metoclopramide Hydrochloride |
Batch No. |
20130701 |
||
Mfg. date |
2013.07.02 |
Report Date |
2013.06 |
||
Exp. date |
2015.07 |
Quantity |
500kg |
||
|
|||||
Tests |
Specifications |
Results |
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Characters |
White or almost white, crystalline powder or crystals |
White crystalline powder
|
|||
Very soluble in water,freely soluble in alcohol,sparingly soluble in methylene chloride. |
Complies |
||||
Identification
|
A:should match with the standard |
Complies |
|||
B:should match with the standard |
Complies |
||||
C:should match with the standard |
Complies |
||||
D:should match with the standard |
Complies |
||||
E:should match with the standard |
Complies |
||||
Appearance of solution |
Should be clear and colourless |
Complies |
|||
Water |
4.5%~5.5% |
5.05% |
|||
PH |
4.5~6.0. |
5.60 |
|||
Heavy metal |
≤20ppm |
Complies |
|||
Impurity |
Single Impurity ≤0.5% |
0.15% |
|||
Total Impurity ≤1% |
0.39% |
||||
Sulphated ash |
≤0.1% |
0.04% |
|||
Assay |
99%~101% on anhydrous substance) |
99.57% |
|||
Conclusion:Conforms to BP2011. |
Identification | ||
Name | Metoclopramide hydrochloride | |
Synonyms | 4-Amino-5-chloro-N-(2-diethylaminoethyl)-2-methoxybenzamide hydrochloride | |
Molecular Structure | ||
Molecular Formula | C14H22ClN3O2.HCl;C14H23Cl2N3O2 | |
Molecular Weight | 336.26 | |
CAS Registry Number | 54143-57-6 |
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