Unii-8nz41mik1o
Enoxaparin Sodium
CAS: 679809-58-6
Molecular Formula: C57H82N4Na4O53S3
Unii-8nz41mik1o - Names and Identifiers
| Name | Enoxaparin Sodium |
| Synonyms | Enoxil Clexane Klexane Lovenox Unii-8nz41mik1o Enoxaparin Sodium Enoxaparin SodiuM EP Lovenox (preservative free) Enoxaparin Sodium, Ep Standard ENOXAPARIN SODIUM, EP STANDARD tetrasodium (2R,4S)-2-({(2R,4R,5R,6R)-5-(acetylamino)-6-{[(3S,4R,5R,6R)-6-{[(2R,4R,5R,6R)-5-(acetylamino)-6-{[(3S,4R,5R,6R)-6-({(2R,4R,5R,6R)-5-(acetylamino)-6-{[(3S,4R,5R,6R)-6-{[(2R,4R,5R,6S)-5-(acetylamino)-4-hydroxy-2-(hydroxymethyl)-6-methoxytetrahyd |
| CAS | 679809-58-6 |
| InChI | InChI=1/C57H86N4O53S3.4Na/c1-11(64)58-21-25(69)36(17(7-62)100-50(21)96-5)104-54-32(76)29(73)41(44(111-54)48(83)84)109-52-23(60-13(3)66)27(71)38(19(102-52)9-97-115(87,88)89)106-56-34(78)31(75)40(43(113-56)47(81)82)108-51-22(59-12(2)65)26(70)37(18(8-63)101-51)105-55-33(77)30(74)42(45(112-55)49(85)86)110-53-24(61-14(4)67)28(72)39(20(103-53)10-98-116(90,91)92)107-57-35(114-117(93,94)95)15(68)6-16(99-57)46(79)80;;;;/h6,15,17-45,50-57,62-63,68-78H,7-10H2,1-5H3,(H,58,64)(H,59,65)(H,60,66)(H,61,67)(H,79,80)(H,81,82)(H,83,84)(H,85,86)(H,87,88,89)(H,90,91,92)(H,93,94,95);;;;/q;4*+1/p-4/t15-,17+,18+,19+,20+,21+,22+,23+,24+,25+,26+,27+,28+,29+,30+,31+,32+,33+,34+,35?,36?,37?,38?,39?,40-,41-,42-,43?,44?,45?,50-,51+,52+,53+,54+,55+,56+,57-;;;;/m0..../s1 |
Unii-8nz41mik1o - Physico-chemical Properties
| Molecular Formula | C57H82N4Na4O53S3 |
| Molar Mass | 1859.41 |
| Melting Point | >191°C (dec.) |
| Solubility | Water (Slightly) |
| Appearance | Solid |
| Color | White to Off-White |
| Storage Condition | Room Temperature, Under inert atmosphere |
Unii-8nz41mik1o - Risk and Safety
| HS Code | 3001900190 |
Unii-8nz41mik1o - Nature
Open Data Verified Data
- the sodium salt of aminoglucan sulfate extracted from the intestinal mucosa of pig or cow of this strain is a white or off-white powder with hygroscopicity. Soluble in water.
- in nature, heparin is widely distributed in the liver, lung, heart, spleen, kidney, thymus, intestinal mucosa, muscle and blood of mammals, most of them are combined with proteins to form complexes. This complex has no anticoagulant activity, and the activity increases as the protein is removed. It is excreted from the urine by inactivation of heparanase produced by the liver in vivo.
- It is a mucopolysaccharide containing a sulfate ester, the molecular structure is represented by a tetrasaccharide repeating unit, and the components are glucosamine and iduronic acid and glucuronic acid. Since the heparin molecule contains sulfate anion which accounts for about 40% of the molecular weight, it has many negative charges. This highly negatively charged physical and chemical property interferes with many links in the blood coagulation process. The antithrombotic effect of heparin, in addition to the inhibition of the activity of each coagulation factor, there are vascular wall interactions and other factors. In addition to anticoagulation, heparin also has hypolipidemic effects, anti-atherosclerosis, anti-inflammatory and anti-allergic effects.
Last Update：2024-01-02 23:10:35
Unii-8nz41mik1o - Preparation Method
Open Data Verified Data
- enzymatic hydrolysis-resin method.
- salt solution-resin method.
Last Update：2022-01-01 11:13:15
Unii-8nz41mik1o - Standard
Authoritative Data Verified Data
The sodium salt of amino dextran sulfate extracted from porcine intestinal mucosa of this strain is a mixture of sugar chains with different molecular weights, and is composed of a-D-glucosamine (N-sulfated, O-sulfated or N-acetylated) and O-sulfated uronic acid (a-L-iduronic acid or/H3 glucuronic acid) are alternately linked to form a polymer, which has the effect of prolonging the blood clotting time. According to the dry product, the titer of anti-Ha factor per lmg of this product shall not be less than 180IU, and the titer of anti-Xa factor and anti-IIa factor should be 0.9~1.1.
Last Update：2024-01-02 23:10:35
Unii-8nz41mik1o - Legal requirements
Authoritative Data Verified Data
This product should be extracted from the Quarantine qualified pig intestinal mucosa, and the animal origin of heparin should be identified. The production process should comply with the requirements of the current version of "good manufacturing practice. The production process shall be validated by Virus inactivation and effective removal of harmful contaminants.
Last Update：2022-01-01 11:58:52
Unii-8nz41mik1o - Use
Open Data Verified Data
anticoagulant.
Last Update：2022-01-01 11:13:15
Unii-8nz41mik1o - Trait
Authoritative Data Verified Data
- This product is white or off-white powder; Highly hygroscopic.
- This product is soluble in water.
specific rotation
take this product, precision weighing, adding water to dissolve and quantitative dilution to make a solution containing about 40mg per lml, according to the law (General 0621), the specific rotation should be not less than 50 degrees.
Last Update：2022-01-01 11:58:52
Unii-8nz41mik1o - Safety
Open Data Verified Data
The seal was stored in a cool dark place.
Last Update：2022-01-01 11:13:16
Unii-8nz41mik1o - Differential diagnosis
Authoritative Data Verified Data
- take this product and determine it by the method under the item of potency determination. The ratio of anti-X a factor titer to anti-IIa factor titer should be 0.9~1.10
- take an appropriate amount of this product, add water to dissolve and dilute to prepare a solution containing about 10 mg per 1 ml as a test solution. The ratio of the peak height of dermatan sulfate to the valley height between the peaks of heparin and dermatan sulfate in the chromatogram of the reference solution (3), determined according to the method under related substances, shall not be less than 1.3, in the chromatogram of the test solution, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the control solution (3), and the relative deviation of the retention time should not exceed 5.0%.
- the product of the aqueous solution of sodium salt identification (1) of the reaction (General 0301).
Last Update：2022-01-01 11:58:53
Unii-8nz41mik1o - Exam
Authoritative Data Verified Data
molecular weight and molecular weight distribution
take an appropriate amount of this product, add the mobile phase to dissolve and dilute to make a solution containing about 5mg per 1 ml, as a test solution; Take an appropriate amount of heparin molecular weight control, add mobile phase to dissolve and dilute to make a solution containing about 5mg per lml as a reference solution; Take appropriate amount of heparin molecular weight system applicable reference, add mobile phase to dissolve and dilute to make a solution containing about 5mg per lml, as a system suitability solution. According to the determination of size exclusion chromatography (General rule 0514), hydrophilic modified bonded silica gel was used as filler (TSK pre-column, 6mmx40mm, TSK 4000SW,7.8mm x300mm, TSK 3000SW,7.8 mmX300mm, tandem use); With 0. The mobile phase was 1 mol /L ammonium acetate solution; The flow rate was 0.6ml per minute; The column temperature was 30°C; And the refractive index detector was used. Take 25ul of the applicable solution of the system, inject the liquid chromatograph, adjust the chromatographic system, so that the main peak and the solvent peak can be completely eluted, and the weight average molecular weight should be within 500 of the indicated value. The reference solution 25 u1 was injected into the liquid chromatograph and the chromatogram was recorded. Accurately calculate the total area of heparin peaks (excluding salt peaks) and the cumulative peak area percentage of each point in the chromatogram of the control solution, determine the retention time and the corresponding molecular weight at the point closest to the cumulative peak area percentage in the broad distribution standard table attached to the heparin molecular weight control, with the retention time as the abscissa and the logarithmic value of the molecular weight as the ordinate, using GPC software, fitting cubic equation, establish the calibration curve, the correlation coefficient should not be less than 0.990.
Take sample solution 25 u1, inject human liquid chromatograph, record chromatogram, calculate the weight average molecular weight of the product according to the following formula, should be 15000~19000, the molecular weight greater than 24000 of the fraction should not be greater than 20%, the ratio of the fraction having a molecular weight of 8000 to 16000 to the fraction having a molecular weight of 16000 to 24 000 should be not less than 1.0.
total nitrogen
take this product, according to the nitrogen determination method (General 0704 second method), according to the dry product calculation, the total nitrogen (N) content of this product should be 1.3% ~ 2.5%.
pH
take this product 0.10g, add water lOml dissolution, according to the law (General 0631),pH value should be 5.0~8.0.
clarity and color of solution
take 0.50g of this product, Add 10ml of water to dissolve, the solution should be clear and colorless; If it is turbid, according to UV-visible spectrophotometry (General 0401), determination of absorbance at the wavelength of 640nm, not over 0.018; If color, with the yellow No. 1 Standard Colorimetric liquid (General rule 0901 first method) comparison, not deeper.
nucleic acid
take this product, precision weighing, adding water to dissolve and quantitative dilution of 4mg per lml solution, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 260nm and should not exceed 0.10.
Protein
take an appropriate amount of this product, accurately weigh it, add water to dissolve and quantitatively dilute it to make a solution containing about 30mg per lml as a test solution; Take an appropriate amount of bovine serum albumin reference substance, precision weighing, respectively, with water dissolved and quantitatively diluted into each lml containing 0.10ug, 20ug, 30ug, 40ug and 50ug of the solution, as a reference solution, determined according to the protein content determination method (General 0731 second method). According to the dry product calculation, this product containing protein should not exceed 0.5%.
Related substances
take an appropriate amount of this product, accurately weigh it, add water to dissolve and quantitatively dilute it to make a solution containing about lOOmg per lml, vortex and mix until it is completely dissolved, and accurately measure 0.5, add 0.25ml of 1 mol/L hydrochloric acid solution and 25% ml of 0.05 sodium nitrite solution, mix with shaking, react for 40 minutes, and add 0.2ml of 1 mol/L sodium hydroxide solution to terminate the reaction, as a test solution; another 250mg heparin reference substance was added with 2ml of water, then vortexed and mixed until it was completely dissolved, which was used as reference solution (1); 1.2ml of reference solution (1) was added for precision measurement, add 0.15 of dermatan sulfate control and 0.1 of chondroitin sulfate control as control solution (2); Take of the control solution (2) and dilute it to 1ml with water, as a reference solution (3); Take 0.4ml of the reference solution (1), add 0.1ml of water, mix well, add 0.25ml of 1 mol/L hydrochloric acid solution and 25% ml of 0.05 sodium nitrite solution, shake and mix well, reaction for 40 minutes, add 1 mol/L sodium hydroxide solution 0.2ml to terminate the reaction, as a reference solution (4); Precision Take 0.5ml of reference solution (2), add 0.25ml of 1 mol/L hydrochloric acid solution and 25% ml of 0.05 sodium nitrite solution, shake and mix well, react for 40 minutes, the reaction was terminated by adding 0.2ml of 1 mol/L sodium hydroxide solution as a control solution (5). Ethyl vinyl benzene-divinylbenzene polymer resin with alkanol quaternary ammonium as functional group as filler (AS11-HC anion exchange column, 2mm x AG11-HC, with guard column, 2mm x 50mm, or other suitable chromatographic column with 0.04% sodium dihydrogen phosphate solution (with phosphoric acid to adjust the pH value to 3.0,0.45um filter filter, degassed before use) as mobile phase A, sodium perchlorate-phosphate solution (take 0.04% g of sodium perchlorate, dissolve and dilute to 3.0 with sodium dihydrogen phosphate solution, adjust pH to with phosphoric acid, filter through 0.45um filter, and Degas immediately before use) mobile Phase B; Flow rate of 0.22 mL per minute; Detection wavelength of 202mn. The linear gradient elution was performed as follows. Take the reference solution (4) and (5) of 20 u1 respectively, inject the human liquid chromatograph respectively, record the chromatogram, the reference solution (4) chromatogram should not appear heparin peak, the resolution of the chromatographic peaks of dermatan sulfate and chondroitin Polysulfate in the chromatogram of the reference solution (5) shall not be less than 3.0. 20ul of the sample solution was accurately measured and injected into the liquid chromatograph, and the chromatogram was recorded. The Peak area of dermatan sulfate in the chromatogram of the test solution shall not be greater than the peak area (2.0%) of dermatan sulfate in the reference solution (5); No other chromatographic peaks shall appear except the dermatan sulfate peak.
residual solvent
take about 2.0g of this product, weigh it accurately, put it in a 10ml measuring flask, and add an internal standard solution (weigh an appropriate amount of N-propanol and dilute it with water to make a solution containing about 80ug per 1 ml) dissolve and dilute to the scale, shake well, take 3ml accurately, put it in a headspace bottle with 500mg of sodium chloride in advance, seal it as a test solution; Take appropriate amount of methanol, ethanol and acetone, precision weighing, quantitative dilution with internal standard solution is made into a mixed solution containing methanol 400ug, ethanol 400ug and acetone 80ug per lml, and the precision volume is 3ml, A headspace bottle with 500mg of sodium chloride in advance was placed, sealed, and used as a control solution. According to the test for determination of residual solvents (General rule 0861, second method), a capillary column with 6% cyanopropylphenyl-94% dimethylpolysiloxane (or similar polarity) as stationary liquid is used as the column; The initial temperature is 40°C, maintain 4 minutes, at a rate of 3°C per minute to 58°C, and then at a rate of 20°C per minute to 160°C; Injection temperature is 160°C; Detector temperature is 250°C; the Headspace bottle equilibration temperature was 90°C and the equilibration time was 20 minutes. The reference solution was sampled by Headspace injection, and the chromatogram was recorded. The order of peaks was methanol, ethanol, acetone and N-propanol. Then the sample solution and the reference solution were injected with headspace, and the chromatogram was recorded. According to the internal standard method to calculate the peak area, methanol, ethanol and acetone residues should be in accordance with the provisions.
loss on drying
take this product, put it in a phosphorus pentoxide dryer, and dry it under reduced pressure at 60°C to a constant weight, and the weight loss shall not exceed 5.0% (General rule 0831).
ignition residue
take 0.50g of this product, check according to law (General 0841), residue should be 28.0% ~ 41.0%.
NA/h4>
This product is about 50mg, precision weighing, set 100ml measuring flask, add 0.lml/L hydrochloric acid solution (containing 1.27mg of cesium chloride in each lml) dissolved and diluted to the scale, shake, as a test solution. Accurately measure the sodium single element standard solution (containing Na 200ug per lml), and quantitatively dilute with the above hydrochloric acid solution to prepare solutions containing sodium 25ug, 50ug and 75ug per lml, as a control solution of a series of concentrations. The absorbance of each of the above reference solution and the test solution was measured at a wavelength of 0406 · Onm by atomic absorption spectrophotometry (General rule 330, Method 1). According to the dry product calculation, sodium in this product (Na) should be 10.5% ~ 13.5%.
Heavy metals
The residue left under the ignition residue item shall not contain more than 30 parts per million of heavy metal when examined by law (General rule 0821, Law II).
bacterial endotoxin
take this product, check according to law (General Principles 1143), each unit of heparin containing endotoxin should be less than 0.010EU.
Last Update：2022-01-01 11:58:54
Unii-8nz41mik1o - Titer determination
Authoritative Data Verified Data
- Anti-Factor Xa Tris (hydroxymethyl) aminomethane-polyethylene glycol 6000 buffer solution (pH 8.4) take Tris (hydroxymethyl) aminomethane 6.06g, sodium chloride 10.23g, disodium ethylenediaminetetraacetate 6000g, polyethylene glycol l. 0g, 8.4 ml of water was added to dissolve, the pH was adjusted to with hydrochloric acid, and diluted to ML with water.
- preparation of standard solution and test solution appropriate amounts of standard (S) and Test (T) were taken and Tris (hydroxymethyl) aminomethane-polyethylene glycol 6000 buffer solution (pH8.4) was added. 4 solutions of different concentrations were prepared by dissolving and diluting each solution. This concentration should be within the linear range of the log dose-response, typically 0.01 to 0.1IU per 1 ml.
- antithrombin solution antithrombin (ATIE) was taken, dissolved and diluted by adding Tris (hydroxymethyl) aminomethane-polyethylene glycol 6000 buffer (pH 8.4) to prepare a solution containing 1IU of antithrombin per 1 ml.
- Factor Xa solution factor Xa (FXa) was taken, dissolved and diluted with Tris-(hydroxymethyl) aminomethane-polyethylene glycol 6000 buffer (pH 8.4) to make about 0.4IU (or 7.lnkat) solution, adjust the concentration to make it in trimethylolmethane-polyethylene glycol 6000 buffer (pH 8.4) instead of heparin as a blank solution (BhBO anti-factor Xa experiment, the absorbance value at a wavelength of 0.8 nm was 1.0.
- chromogenic substrate solution a chromogenic substrate S-2765 (or other FXa-specific chromogenic substrate) was taken and water was added to make a solution of 0.003mol/L, which was diluted to 1 mmol/L with water immediately before use.
- determination of different concentrations of standard (S) series solution or test (T) series solution and the above buffer (B ), according to B1, S1, S2, S3, the order of S4, T1, T2, T3, T4, S1, S2, S3, S4, B2 to each small tube in the order of precision plus about 20~50u1 the same volume (V) the above buffer solution (B ), standard (S) series solution or test sample (T) series solution, and then add the same volume (V) of antithrombin solution, mix, balance at 37°C for 2 minutes, add appropriate amount of factor Xa solution (2v) to each tube, mix well, balance at 37°C for 2 minutes, then add appropriate amount of chromogenic substrate solution (2v) to each tube, mix well, after accurately keeping the temperature at 37 ° C. For 2 minutes, an appropriate amount (2v) of 50% acetic acid solution was added to each precision to terminate the reaction. The absorbance of each tube was measured at a wavelength of 405nm using appropriate equipment. The absorbance of B1 and B2 tubes shall not be significantly different. The absorbance is taken as the ordinate, and the logarithmic value of the concentration of the standard sample series solution (or test sample series solution) is taken as the abscissa for linear regression respectively, and the bioassay Statistics method is applied (General rule 1431). In the amount of reaction in the principle of parallel line 4X4 method experimental design, calculation of potency and experimental error. The mean confidence limit (FL%) must not be greater than 10%.
- Anti-Factor la Tris (hydroxymethyl) aminomethane-polyethylene glycol 6000 buffer (pH 8.4) was formulated under anti-factor Xa.
- preparation of standard solution and test solution appropriate amounts of standard (S) and Test (T) were taken, and trimethylol aminomethyl-polyethylene glycol 6000 buffer solution (pH8.4) was added. 4 solutions of different concentrations were prepared by dissolving and diluting each solution. This concentration should be in the linear range of log dose-response, typically 0.005 to 0.05IU per 1 ml.
- antithrombin solution antithrombin (ATIE) was taken, dissolved and diluted by adding Tris-(hydroxymethyl) aminomethane-polyethylene glycol 6000 buffer (pH 8.4) to prepare a solution containing IU of antithrombin per 1 ml.
- thrombin solution thrombin (Flla) was taken, dissolved and diluted with Tris (hydroxymethyl) aminomethane-polyethylene glycol 6000 buffer (pH 8.4) to make a solution containing about 5IU per 1 ml, and the concentration was adjusted, in an anti-factor IIa experiment in which heparin was replaced by a solution of Tris (hydroxymethyl) aminomethane-polyethylene glycol 6000 buffer (pH 8.4) as a blank solution (B1, B2), the absorbance values at a wavelength of 40 5nm ranged from 0.8 to 1.0.
- chromogenic substrate solution a chromogenic substrate S-2238 (or other Flla-specific chromogenic substrate) was taken and water was added to make a solution of 0.003mol/L, which was diluted to 0.625mmol/L with water immediately before use.
- determination of different concentrations of standard (S) series solution or test (T) series solution and the above buffer (B), according to B1, S1, S2, S3, the order of S4, T1, T2, T3, T4, S1, S2, S3, S4, B2 to each small tube in the order of precision plus about 20 ~ 50ul of the same volume (V) the above buffer solution (B), standard (S) series solution or test sample (T) series solution, and then add the same volume (V) of antithrombin solution, mix, balance at 37°C for 2 minutes, add appropriate amount of thrombin solution (2v) into each tube, mix well, balance at 37°C for 2 minutes, then add appropriate amount of human chromogenic substrate solution (2v), mix well, after accurately keeping the temperature at 37 ° C. For 2 minutes, an appropriate amount (2v) of 50% acetic acid solution was added to each precision to terminate the reaction. The absorbance of each tube was measured at a wavelength of 405nm using appropriate equipment. The absorbance of B1 and B2 tubes shall not be significantly different. The absorbance is taken as the ordinate, and the logarithmic value of the concentration of the standard sample series solution (or test sample series solution) is taken as the abscissa for linear regression respectively, and the bioassay Statistics method is applied (General rule 1431). In the amount of reaction in the principle of parallel line 4X4 method experimental design, calculation of potency and experimental error. The mean confidence limit (FL%) must not be greater than 10%.
- The titer of anti-Ha factor should be 90% ~ 110% of the indicated value, and the titer ratio of anti-X a factor to anti-n a factor should be in accordance with the regulations.
Last Update：2022-01-01 11:58:55
Unii-8nz41mik1o - Category
Authoritative Data Verified Data
anticoagulant.
Last Update：2022-01-01 11:58:56
Unii-8nz41mik1o - Storage
Authoritative Data Verified Data
sealed and stored in a dry place.
Last Update：2022-01-01 11:58:56
Unii-8nz41mik1o - Heparin Sodium cream
Authoritative Data Verified Data
This product should contain heparin sodium label amount of 90% ~ 110%.
trait
This product is white cream.
identification
- take this product, according to heparin sodium under the identification of (1) test, showed the same results.
- take an appropriate amount of this product (about 700 units equivalent to heparin sodium), add 60% ethanol solution to 10ml, heat it in a water bath to dissolve it, place it in a refrigerator at 4°C for about 5 hours, remove it, filter it, the filtrate was taken as the test solution; Another heparin sodium standard was taken, dissolved in water and diluted to prepare a standard solution containing 200 units per 1 ml. Take 20 u1 of each of the standard solution and the test solution, and test according to electrophoresis method (General 0541 third method), the ratio of the migration distance of the electrophoretic band exhibited by the test solution and the control solution should be 0.9 to 1.1.
- take the test solution under the identification (1), and identify the reaction of (1) with sodium salt (General rule 0301).
examination
- the pH value of this product is lg, 10ml of water is added, mixed well, and measured according to law (General rule 0631). The pH value should be 6.5~8.5.
- others should comply with the relevant provisions under the cream (General rule 0109).
titer determination
take about 2g of this product, weigh it accurately, add 30ml of anhydrous ethanol, heat it on a water bath to dissolve it, let it cool, move it to a 100ml measuring flask, dilute it to the scale with 0.9% sodium chloride solution, shake well, place in 4°C refrigerator overnight, remove, filter, take the filtrate (50ml) accurately, then evaporate on a water bath until no ethanol odor, and transfer to a 50ml measuring flask, dilute with 0.9% sodium chloride solution to the scale, shake, according to the method under the heparin sodium, that is obtained.
category
anticoagulant.
specification
(l)20g:5000 units (2)20g:7000 units (3)25g:8750 units
storage
sealed storage.
Last Update：2022-01-01 11:58:56
Unii-8nz41mik1o - Heparin Sodium injection
Authoritative Data Verified Data
This product is a sterilized aqueous solution of heparin sodium. The potency should be between 90% and 110% of the labeled amount.
trait
This product is colorless to light yellow clear liquid.
identification
- take this product, according to heparin sodium under the identification of (1) test, showed the same results.
- take this product (2ml:1000 units specification) or take an appropriate amount of this product and dilute it with water to make a solution containing about 1000 units per 1 ml, according to the identification under heparin sodium (2) the same results were seen in one trial.
- This product shows the reaction of sodium salt identification (1) (General rule 0301).
examination
- molecular weight and molecular weight distribution take this product (2ml: 1000 unit specification) or take an appropriate amount of this product and dilute it with mobile phase to prepare a solution containing 1000IU per lm l as a test solution, determined according to the method under heparin sodium. The weight average molecular weight of this product should be 15 000~19 000, and the molecular weight of more than 24 000 should not be greater than 20%, the ratio of the fraction having a molecular weight of 8000 to 16 000 to the fraction having a molecular weight of 16 000 to 24 000 should be not less than 1.0.
- the pH value should be 5.5 to 8.0 (General 0631).
- Related Substances: Take 0.5ml of this product, add 0.25ml of lm o l/L hydrochloric acid solution and 25% sodium nitrite solution 0. 05ml, shake and mix well, react for 40 minutes, add lm o l/L sodium hydroxide solution 0.2ml to stop the reaction, as a test solution. According to the method under the heparin sodium check, should comply with the provisions.
- bacterial endotoxin should be checked according to the method under heparin sodium, and it should be in accordance with the regulations.
- others should comply with the relevant provisions under injection (General 0102).
titer determination
take this product, according to the method of heparin sodium determination, that is.
category
Same as heparin sodium.
specification
(l)2ml:1000 units (2)2ml:5000 units (3)2ml:12500 units
storage
sealed storage.
Last Update：2022-01-01 11:58:57
Unii-8nz41mik1o - Reference Information
| toxic substance data | information provided by: pubchem.ncbi.nlm.nih.gov (external link) |
Last Update：2024-04-09 21:11:58
Supplier List
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Product Name: ENOXAPARIN SODIUM, EP STANDARD Visit Supplier Webpage Request for quotationCAS: 679809-58-6
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
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Wechat: 18301782025
Spot supply
Product Name: ENOXAPARIN SODIUM, EP STANDARD Visit Supplier Webpage Request for quotationCAS: 679809-58-6
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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