Detection method of boron content in the production process of dalteparin sodium
A production process, the technology of dalteparin sodium, applied in the field of biomedicine, can solve the problems of ineffective detection of boron element, reproductive system and endocrine system toxicity, etc., and achieve the goal of facilitating industrial promotion and application, reducing the risk of unqualified products, and reducing the risk of drug use Effect
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Embodiment 1
[0034] 1. Instruments and utensils:
[0035] Inductively coupled ion spectrometer, electronic balance, volumetric flask (10ml, 25ml, 50ml, 100ml, 500ml, 1000ml), beaker (500ml, 1000ml), pipette gun.
[0036] 2. Reagents and reagents:
[0037] Nitric acid (analytical pure), boric acid (analytical pure), enoxaparin sodium.
[0038] 3. Solution preparation:
[0039] Control solution a: prepare 1% (v / v) nitric acid aqueous solution (blank);
[0040] Control solution b: prepare 5.7μg / mL boric acid solution with 1% nitric acid solution (STD cal );
[0041] Control solution c: Weigh 0.25g of enoxaparin sodium and dissolve it in 2mL of water, add 100μL of pure nitric acid, and dilute to 10mL with water (STD 0 );
[0042] Linear solution 1: Weigh 0.25g enoxaparin sodium and dissolve in 2mL 1% nitric acid, add 2.0μL 5.7mg / mL boric acid, and dilute to 10mL (0.2ppm) with 1% nitric acid solution;
[0043] Linear solution 2: Weigh 0.25g enoxaparin sodium and dissolve in 2mL 1% nitric...
Embodiment 2
[0060] The sample IZDA140328 was detected according to the method described in Example 1.
[0061] Table 2 data
[0062] project
value
Linear solution 4 (STD 1 )
2058
STD 0
235
STD cal
1851
blank
116
Linear Solution 1
687
Linear Solution 2
1031
[0063] Linear solution 3
1719
Linear solution 5
2417
sample solution
380
[0064] Calculation: Correction factor f:
[0065]
[0066] Draw a standard curve, as shown in the accompanying drawing figure 2 (Boron content and response value linear relationship diagram) as shown:
[0067] According to the standard curve, the linear equation obtained is: y=1724.9x+340.44, R 2 =0.9999
[0068] Boron content: [(380-340.44) / 1724.9]*1.02=0.023ppm.
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