Heparin Sodium directly manufacture with best price 2016

Name 

   Heparin Sodium

Batch No. 

ZH150504

Specification 

   API

Test Date 

2015.05.14

Report Date

2015.05.21

Total Quantity

62.485 Kg

Expiry Date

      2018.05.13

Test Standard 

CP 2010 V2

Test Items

Standards

Results

1

Character

White or off white powder, hygroscopic, freely soluble in **,

Qualified

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

3

B:Sodium Salt

Sodium salt is found in ** solution.

 Qualified

4

Test

Specific Rotation

≥+50º

+50.5º

5

Total Nitrogen

1.3%~2.5%

2.0%

6

PH

5.0~7.5

7.4

7

Clarity and Color of Solution

Meet the standard

Qualified 

8

Absorbance

260nm:≤0.10

0.035

280nm≤0.10

0.021

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

10

Residue Solvant

Calculated with peak area according to internal standard method, content of methanol, ethanol and acetone 

should be separately less than 0.3%, 0.5% and 0.5%.

Methanol:Negative

Ethanol:0.0007%

Acetone:Negative

11

Loss on Drying

≤ 5.0%

1.3%

12

Residue on Ignition 

28.0%~41.0%

38.6%

13

Sodium 

9.5%~12.5%

11.1%

14

Heavy Metal

           ≤Thirty millionths

Qualified

15

Bacterial Endotoxin 

< 0.010EU/(IUof heparin)

Qualified

16

Potency

≥170IU/mg(Should be 91%~110% of labeled amount)

208IU/mg

17

Microbial Limit

Bacterium

≤100CFU/g

<10CFU/g

18

Mould

≤10CFU/g

<10CFU/g

19

   E.coli

Negative

Negative

20

Salmonella

Negative

Negative

Conclusions 

The product is qualified after tested according to CP2010 V2