Amoxicillin trihydrate
1.Cas no.: 61336-70-7
2.Appearance: white powder
3.Quality standard: USP/BP/EP
|
REPORTING DATE |
: DEC. 15, 2007 |
|
PRODUCT |
: AMOXICILLIN TRIHYDRATE POWDER |
|
BATCH NO. |
: 0712791 |
|
QUANTITY |
: 405.00KGS |
|
PACKING |
: 20KG/DRUM |
|
MFG. DATE |
: DEC. 11, 2007 |
|
EXP. DATE |
: DEC. 10, 2009 |
|
ITEMS
|
SPECIFICATIONS |
RESULTS |
|
DESCRIPTION |
A WHITE or ALMOST WHITE, CRYSTALLINE POWDER |
A WHITE CRYSTALLINE POWDER |
|
SPECIFIC OPTICAL ROTATION |
+290°- + 315° |
+302° |
|
IDENTIFICATION |
CONFORM |
CONFORM |
|
PH |
3.5 - 5.5 |
4.8 |
|
APPEARANCE OF SOLUTION - 0.5L/mol solution of hydrochloric acid - 20L/mol solution of ammonia |
LESS THAN 2# (CP2005 STANDARD) |
1# |
|
** |
11.5% - 14.5% |
13.6% |
|
DIMETHYLANILINE |
NOT MORE THAN 20ppm |
NOT FOUND |
|
RELATED SUBSTANCE (SINGLE IMPURITY) |
LESS THAN 1% |
0.2% |
|
SULPHATED ASH |
LESS THAN 1.0% |
0.2% |
|
ASSAY (AS ANHYDROUS SUBSTANCE) |
95% - 102.0% |
99.6% |
CONCLUSION: THE ABOVE ITEMS ARE IN COMPLIANCE WITH EP5.
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