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| CERTIFICATE OF ANALYSIS |
Name of Product |
ANALGIN |
Lot No. |
0406021 |
No. |
06021 |
Quantity |
4000Kg |
Test Date |
JUN.22,2004 |
Manufacture Date |
JUN.21,2004 |
Expiry Date |
JUN.21,2008 |
Quality Standard |
DAB 10 |
|
Tests |
Standards |
Results |
Appearance |
Pass |
Pass |
Identification |
Positive |
Positive |
Clarity of solution (5%) |
Clear |
Clear |
Absorbance of 160 g/l |
0-0.1% |
0.08% |
Test with sulphuric acid |
Clear and colorless |
Clear |
Color of solution (5%) |
¡Ü BG6,BY6 |
< BG6,BY6 |
Acidity and alkalinity |
PH=6.2-7.2 |
PH=6.5 |
Residual solvents:
Benzen
Chloroform
1,4-dioxane
Methylene chloride
Trichlomenthylene |
NMT 2 PPM
NMT 60 PPM
NMT 380 PPM
NMT 600 PPM
NMT 80 PPM |
0.2PPM
12PPM
120PPM
100PPM
10PPM |
Related substance (TLC) |
0-0.1% |
<0.1% |
FREE PYROGEN(100%) |
Complies |
Complies |
Related substance (HPLC)
Single impurity:
Impurity:
Total impurity: |
• 2%
• 5%
0-0.5% |
0.05%
0.02%
0.05% |
Sulfate |
0-0.1% |
0.05% |
Heavy metals |
0-0.002% |
0.001% |
Loss on drying |
4.9-5.3% |
5.0% |
Assay |
99.0-101.0% |
99.5% |
| Conclusion:Complies with DAB10 |
|
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