| Heparin Sodium | ||||
| Source | Intestinal mucosa of pigs | |||
| Quality standard |
CP |
USP |
EP |
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|
characters |
Appearance |
white or almost white; hygroscopic powder |
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white or almost white; hygroscopic powder |
| solubility |
freely soluble in water |
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freely soluble in water |
|
| specific rotation |
≥+50° |
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| identification | Anti- Xa activity/ anti- IIa : 0.9 - 1.1 | Anti- Xa activity/ anti- IIa : 0.9 - 1.1 | Anti- Xa activity/ anti- IIa : 0.9 - 1.1 | |
| reference solutions(3）：peak-to-valley minimum 1.3；the principal peak in the chromatogram obtained with test solution(a) is NMT 5% (RSD)in retention time and shape to the principal peak in the chromatogram obtained with reference solutions(3） |
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reference solutions(C）：peak-to-valley minimum 1.3；the principal peak in the chromatogram obtained with test solution(a) is similar in retention time and shape to the principal peak in the chromatogram obtained with reference solutions(C） | ||
| It gives positive reaction of sodium | A solution of Heparin Sodium imparts an intense yellow color to a nonluminous flame | It complies with the test for sodium | ||
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No unidentified signals greater than 4% of the mean of the height of signals 1 and 2 are present in the following ranges:0.10-2.00,2.10-3.20,and 5.70-8.00ppm,No signals greater than 200% of the mean of the height of signals and 2 arepresent in the 3.75-4.55ppm for porcine heparin | No unidentified signals greater than 4% of the mean of the height of signals 1 and 2 are present in the following ranges:0.10-2.00,2.10-3.20,and 5.70-8.00ppm,No signals greater than 200% of the mean of the height of signals and 2 are present in the 3.75-4.55ppm for porcine heparin | ||
| MW | M24000 : NMT 20%, Mw : 15,000 -19,000Da, and the ratio of M8000-16000 /M16000-24000 ≥1.0 | M24000 : NMT 20%, Mw : 15,000 -19,000Da, and the ratio of M8000-16000 /M16000-24000 ≥1.0 | M24000 : NMT 20%, Mw : 15,000 -19,000Da, and the ratio of M8000-16000 /M16000-24000 ≥1.0 | |
| Nitrogen | 1.5 -2.5 % (on the dried basis) | 1.3 -2.5 % (on the dried basis) | 1.5 -2.5 % (on the dried basis) | |
| pH | 5.0-8.0 | 5.0-7.5 | 5.0-8.0 | |
| Appearance of solution | clear；NMT: intensity 1 |
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clear；NMT: intensity 5 | |
| Nucleotidic impurities | A260nm is not greater than 0.10 | NMT 0.1% (w/w) | A260nm is not greater than 0.15 | |
| Protein | ≤0 0.5 per cent (on the dried basis) | NMT 0.1% (w/w) | ≤0.5 %(on the dried basis) | |
| Related substances | no more than the area of the peak due to dermatan sulfate and chondroitin sulfate in the chromatogram obtained with reference solutions(5）(2.0 per cent)；no peak with an area greater than 0.01 times the area of the peak due to dermatan sulfate and chondroitin sulfate in the chromatogram obtained with reference solutions(e）is detected |
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no more than the area of the peak due to dermatan sulfate and chondroitin sulfate in the chromatogram obtained with reference solutions(e）(2.0 per cent);no peak with an area greater than 0.01 times the area of the peak (corresponding to a disregard limit of 0.02 per cent) | |
| Residual solvents | Ethanol≤0.5% |
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| Loss on drying | NMT 5.0% | NMT 5.0% | NMT 8.0% | |
| Residue on Ignition | 28.0%-41.0% | 28.0%-41.0% | / | |
| Sodium | 10.5 per cent to 13.5 per cent (dried substance) |
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10.5 per cent to 13.5 per cent (dried substance) | |
| Heavy metals | ≤30ppm |
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| Bacterial endotoxins | ＜0.010EU/IU | <0.03EU/U | ＜0.010EU/IU | |
| Limit of Galactosamine in Total Hexosamine |
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NMT 1% |
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| Absence of Oversulfated Chondroitin Sulfate |
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NO features associated with oversulfated chondroitin sulfate are found between 2.12 and 3.00 ppm; No peaks corresponding to oversulfated chondroitin sulfate should be detected eluting after the heparin peak |
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| Assay | ≥180 IU/mg (on the dried basis) | ≥180 USP U/mg (on the dried basis) | ≥180 IU/mg (on the dried basis) | |