TESTS

SPECIFICATIONS

Characters

White or almost white, hygroscopic powder.

Solubility

Freely soluble in water

Identification

A. It complies with the requirements described under Assay

B. The ratio of anti-factor Xa activity to anti-factor IIa activity ranges between 0.9~1.1.

C. ¹H-NMR Spectrum: comply with the Ph. Eur. specification of heparin about ¹H-NMR requirements.

D. The principal peak in the chromatogram obtained with test solution is similar in retention time and shape to the principal peak in the chromatogram obtained with reference solution.

E. It complies with the test for sodium.

Appearance of solution

The solution is clear and not more intensely coloured than intensity 5 of the range of reference solutions of the most appropriate color.

pH

5.5 ~ 8.0

Nucleotide impurities

Absorbance at 260 nm: ≤0.15

Protein

≤0.5%

Related substances

A. Sum of dermatan sulfate and chondroitin sulfate: not more than the area of the peak due to dermatan sulfate and chondroitin sulfate in the chromatogram obtained with reference solution (e) (2.0 per cent);

B. Any other impurity: 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 solution (e) is detected (corresponding to a disregard limit of 0.02 per cent)

Nitrogen

1.5%~2.5%

Sodium content

10.5%~13.5%

Loss on drying

≤8.0%

Bacterial endotoxin

Less than 0.01 IU/IU of heparin

Potency

≥180 IU/mg

TESTS

SPECIFICATIONS

Characters

White or almost white, hygroscopic powder.

Solubility

Freely soluble in water

Identification

1. ¹H-NMR Spectrum: 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 5.70–8.00 ppm. No signals greater than 200% of the mean of the height of signals 1 and 2 are present in the 3.75–4.55 ppm for porcine heparin .
2. Chromatographic: The retention time pf the major peak of the Sample solution corresponds to that of the Standard solution.
3. Anti-factor Xa to anti-factor Ⅱa ratio: 0.9 – 1.1
4. Molecular weight: M is NMT 20%, M is between 15,000 Da and 19,000 Da, and the ratio of M to M is NLT 1.0.
5. A solution of Heparin Sodium imparts an intense yellow color to a nonluminous flame.

Appearance of solution

The solution is clear and not more intensely coloured than intensity 5 of the range of reference solutions of the most appropriate color.

pH

5.0 ~ 7.5

Nucleotide impurities

NMT 0.1% (w/w) is found.

Protein

NMT 0.1% (w/w) is found.

Related substances

1. Proceed as directed in Identification A. No features associated with oversulfated chondroitin sulfate are found between 2.12 and 3.00 ppm.

1. Proceed as directed in Identification B. No peaks corresponding to oversulfated chondroitin sulfate should be detected eluting after the heparin peak.

Loss on drying

≤5.0%

Bacterial endotoxin

It contains NMT 0.03 USP Endotoxin Units/USP Heparin Unit.

Potency

≥180 IU/mg