CERTIFICATE OF ANALYSIS
NAME OF PRODUCT: METRONIDAZOLE BATCH NO.: YA-102908
REPORT DATE: OCT 12,1998
|
ITEMS |
STANDARDS |
RESULTS |
|
IDENTIFICATION: |
AS STIPULATED |
PASS |
|
MELTING POINT: |
159.0 – 163.0 ℃ |
160.3 – 161.2 ℃ |
|
LOSS ON DRYING: |
0.5% MAX. |
0.07% |
|
RESIDUE ON IGNITION: |
0.1% MAX. |
0.02% |
|
HEAVY METALS: |
0.005% MAX. |
PASS |
|
NON-BASIC SUBSTANCES: |
AS STIPULATED |
PASS |
|
CHROMATOGRAPHIC PURITY: |
AS STIPULATED |
PASS |
|
BULK DENSITY: |
AS STIPULATED |
0.65gr/ml |
|
GRANULOMETRIC ANALYSIS: |
AS STIPULATED |
40MESH |
|
ASSAY: |
99.0 – 101.0% |
100.1% |
|
CONCLUSION: |
CONFORMS TO USP23 |
|