|
Name |
Heparin Sodium |
Batch No. |
ZH150504 |
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|
Specification |
API |
Test Date |
2015.05.14 |
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|
Report Date |
2015.05.21 |
Total Quantity |
62.485 Kg |
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|
Expiry Date |
2018.05.13 |
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|
Test Standard |
CP 2010 V2 |
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|
Test Items |
Standards |
Results |
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|
1 |
Character |
White or off white powder, hygroscopic, freely soluble in **, |
Qualified |
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|
2 |
Identi-ficat-ion |
A:HPLC |
In chromatogram recorded under concerned matter, the retention time of main peak of test solution should be accordance with reference solution. |
Qualified |
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|
3 |
B:Sodium Salt |
Sodium salt is found in ** solution. |
Qualified |
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|
4 |
Test |
Specific Rotation |
≥+50º |
+50.5º |
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|
5 |
Total Nitrogen |
1.3%~2.5% |
2.0% |
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|
6 |
PH |
5.0~7.5 |
7.4 |
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|
7 |
Clarity and Color of Solution |
Meet the standard |
Qualified |
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|
8 |
Absorbance |
260nm:≤0.10 |
0.035 |
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|
280nm≤0.10 |
0.021 |
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|
9 |
Concerned Matter |
Dermatan sulfate ≤ 5.0%,other impurities are not less than 3.0% which is calculated with area normalization method after main peak of heparin sodium. |
Dermatan sulfate:0.8% Other impurities: Negative |
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|
10 |
Residue Solvant |
Calculated with peak area according to internal standard method, content of methanol, ethanol and acetone |
Methanol:Negative Ethanol:0.0007% Acetone:Negative |
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|
11 |
Loss on Drying |
≤ 5.0% |
1.3% |
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|
12 |
Residue on Ignition |
28.0%~41.0% |
38.6% |
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|
13 |
Sodium |
9.5%~12.5% |
11.1% |
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|
14 |
Heavy Metal |
≤Thirty millionths
|
Qualified |
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|
15 |
Bacterial Endotoxin |
< 0.010EU/(IUof heparin) |
Qualified |
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|
16 |
Potency |
≥170IU/mg(Should be 91%~110% of labeled amount) |
208IU/mg |
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|
17 |
Microbial Limit |
Bacterium |
≤100CFU/g |
<10CFU/g |
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|
18 |
Mould |
≤10CFU/g |
<10CFU/g |
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|
19 |
E.coli |
Negative |
Negative |
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|
20 |
Salmonella |
Negative |
Negative |
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|
Conclusions |
The product is qualified after tested according to CP2010 V2 |
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