146475-23-2
ondansetron hydrochloride
CAS: 146475-23-2;146844-89-5
Molecular Formula:
146475-23-2 - Names and Identifiers
146475-23-2 - Standard
Authoritative Data Verified Data
This product is 2, 3-dihydro-9-methyl-3-[(2-methylimidazol-1-yl) methyl]-4(1H)-Carbazolone hydrochloride dihydrate. The amount of C18 h19n30. HCl should be between 98.0% and 102.0% based on the anhydrous content.
Last Update：2024-01-02 23:10:35
146475-23-2 - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Odorless.
- This product is soluble in fermentation broth, slightly soluble in water, slightly soluble in acetone; Slightly soluble in 0.lmol/L hydrochloric acid solution.
melting point
take this product, with phosphorus pentoxide as drying agent for 30 minutes after drying, measured according to law (General 0612), melting point of 175~180°C, while melting decomposition.
Last Update：2022-01-01 15:06:09
146475-23-2 - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, add 5ml of water to dissolve, and add 1ml of dilute bismuth potassium iodide test solution to generate scarlet precipitate.
- take this product, add 0.lmol/L hydrochloric acid solution was dissolved and diluted to prepare a solution containing about 10ug per lml, which was determined by UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at 267nm and 310nm wavelengths, and a minimum absorption at 282nm and 257mn wavelengths.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 832).
- This product is chloride identification reaction (General 0301).
Last Update：2022-01-01 15:06:10
146475-23-2 - Exam
Authoritative Data Verified Data
acidity
take 0.10g of this product, Add 10ml of water to dissolve, and measure according to law (General rule 0631). The pH value should be 4.0~5.5.
clarity and color of solution
take 0.10g of this product, Add 10ml of water to dissolve, the solution should be clear and colorless. If it is turbid, it should not be more concentrated compared with No. 1 turbidity standard solution (General rule 0902 first method); If it is colored, it should not be deeper compared with yellow No. 1 Standard Colorimetric solution (General rule 0901 first method).
Related substances
take an appropriate amount of this product, add the mobile phase to dissolve and dilute to make a solution containing about 0.5mg per lml as a test solution; Take 1ml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. In addition to the detection wavelength of 216mn, according to the chromatographic conditions under the content determination item, take the sample solution and the control solution with 10 u1 respectively, and inject the human liquid chromatograph respectively, the chromatogram was recorded to 4 times the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution.
residual solvent
take an appropriate amount of this product, precision weigh, add water to dissolve and dilute to make a solution containing about 20mg per lml, as a test solution; Take an appropriate amount of toluene and acetone, precision weigh, A solution containing about 17.8UG and 100ug per 1 ml was prepared by diluting with water as a control solution. According to the residual solvent determination method (General 0861 third method), 5% phenyl-95% methyl polysiloxane capillary column was used, and the column temperature was 50°C. The separation degree of toluene peak and acetone peak shall meet the requirements. 1~3 u1 of each of the test solution and the reference solution were accurately measured and injected into the human gas chromatograph respectively, and the chromatogram was recorded. According to the external standard method to calculate the peak area, toluene and acetone residues should be in accordance with the provisions.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the moisture content should be 9.0% ~ 10.5%.
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 15:06:10
146475-23-2 - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
A cyanosilane-bonded silica gel was used as the filler, and 0.02mol/L sodium dihydrogen phosphate solution (adjusted to pH 5.4 with sodium hydroxide solution)-acetonitrile (50:50) was used as the mobile phase; the detection wavelength was 310Nm. The number of theoretical plates is not less than 2000 calculated from the ondansetron peak.
assay
take this product, precision weighing, plus mobile phase dissolution and quantitative dilution made in each lml containing about 0.1 mg solution, as the test solution, take the precision amount of 10ul injection liquid chromatography, record the chromatogram; Take the ondansetron hydrochloride control, the same method for determination. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 15:06:11
146475-23-2 - Category
Authoritative Data Verified Data
adjuvant antineoplastic agents
Last Update：2022-01-01 15:06:11
146475-23-2 - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:06:11
146475-23-2 - Zudan (Ondansetron Hydrochloride Tablets)
Authoritative Data Verified Data
This product contains ondansetron hydrochloride according to Ondansetron (C18H19N30) calculation, should be 90.0% ~ 110.0% of the label amount.
trait
This product is white or white-like tablets or film-coated tablets, white or white-like after removing the coating.
identification
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- The test solution under the content uniformity is determined by UV-Vis spectrophotometry (General rule 0401), and has the maximum absorption at the wavelengths of 248nm, 267nm and 310nm, there is minimal absorption at wavelengths of 282mn and 257mn.
- take an appropriate amount of fine powder of this product, add water to dissolve, filter, filtrate chloride to identify (1) reaction (General rule 0301).
examination
- Related substances take an appropriate amount of the fine powder of this product (about 4mg of ondansetron), put it in a 10ml measuring flask, add mobile phase to dissolve ondansetron hydrochloride and dilute to the scale, shake well, filter, the filtrate was taken as the test solution; The precision amount was 1 ml, and the solution was placed in a 100ml measuring flask, diluted to the scale with the mobile phase, and shaken to obtain a control solution. According to the method of ondansetron hydrochloride related substances. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- Content uniformity take 1 tablet of this product, put it in a 100ml measuring flask, add 0.1mol/L hydrochloric acid solution to dissolve ondansetron hydrochloride and dilute to the scale, shake well, filter, take 10ml of continuous filtrate, put it in 50ml measuring flask (4mg specification) or in 100ml measuring flask (8mg specification), use 0. Dilute 1mol/L hydrochloric acid solution to the scale, shake well, as the test solution, according to UV-visible spectrophotometry (General 0401), at the wavelength of 310nm absorbance; another ondansetron hydrochloride reference, precision weighing, plus 0.1mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 8ug of ondansetron per 1 ml, which was determined by the same method. Calculate the content of each tablet, should be in accordance with the provisions (General 0941).
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.lmol/L hydrochloric acid solution 500ml(4mg specification) or 1000ml( 8mg specification) is the dissolution medium, the rotation speed is 50 rpm, the operation is carried out according to law, after 30 minutes, take the appropriate amount of solution, filter, take the filtrate according to UV-visible spectrophotometry (General rule 0401), measure the absorbance at the wavelength of 310mn; Take another ondansetron hydrochloride reference substance, precision weighing, with 0.1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 8ug of ondansetron per 1 ml, which was determined by the same method. The dissolution amount of each tablet was calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
Take 20 tablets of this product, precision weighing, fine grinding, precision weighing appropriate amount (about 8mg of ondansetron), add mobile phase to dissolve ondansetron hydrochloride and dilute quantitatively to prepare a solution containing ondansetron 80ug per 1 ml, shake well, filter, and take the continued filtrate as the test solution, the results were obtained by multiplying the results by 0.8895 as determined under the ondansetron hydrochloride assay.
category
Same as ondansetron hydrochloride.
specification
Based on C18H19N30 (l)4mg (2)8Mg
storability
shade, seal, and store in a cool and dry place.
Last Update：2022-01-01 15:06:12
146475-23-2 - OndansetronHydrochlorideInjection
Authoritative Data Verified Data
This product is a sterile aqueous solution of ondansetron hydrochloride. The content of ondansetron hydrochloride shall be between 93.0% and 107.0% of the indicated amount calculated as ondansetron (C18H19N30).
trait
This product is a clear colorless liquid.
identification
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- take this product and use 0.1 mol/L hydrochloric acid solution is diluted to prepare solution containing 10ug per 1 ml, according to UV-visible spectrophotometry (General 0401) determination, at 248nm, there is a maximum absorption at 267nm and 310nm wavelengths, and a minimum absorption at 282nm and 257nm wavelengths.
- This product chloride identification (1) of the reaction (General 0301).
examination
- the pH value should be 3.0 to 4.0 (General 0631).
- appropriate amount of related substances: add mobile phase to prepare a solution containing ondansetron 0.5mg per 1 ml, which is used as a test solution; Take 1 ml for precision measurement, and place it in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. In addition to the detection wavelength of 216mn and 328mn, according to the chromatographic conditions under the content determination item, 10 u1 of the test solution and the control solution are accurately taken and injected into the liquid chromatograph respectively, the chromatogram was recorded to 5 times of the retention time of the main component peak. At the wavelength of 216nm, if there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.2 times (0.2%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution. At a wavelength of 328nm, the peak area of ondansetron hydrochloride impurity I (relative retention time of about 0.6) should not be greater than 1.5 times (1.5%) the area of the main peak of the control solution.
- bacterial endotoxin this product is taken and checked according to law (General rule 1143). The amount of endotoxin contained in ondansetron should be less than 9.9EU per 1 mg.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using cyanosilane-bonded silica gel as a filler (krolmasil CN column, 4.6mm X 250mm, 5um or equivalent chromatographic column); the mobile phase was 0.02mol /L sodium dihydrogen phosphate solution (adjusted to pH 5.4 with sodium hydroxide solution)-acetonitrile (50:50); The detection wavelength was 310nm. The ondansetron peak retention time was approximately 11 minutes; The theoretical plate number was not less than 2000 calculated for the ondansetron peak.
- determination precision: take an appropriate amount of this product and quantitatively dilute it with mobile phase to prepare a solution containing ondansetron 80ug per 1 ml, which is used as a test solution. Take 10ul injection liquid chromatograph for precision measurement, record chromatogram; Another ondansetron hydrochloride reference substance, the same method for determination. According to the external standard method to calculate the peak area, and the result is multiplied by 0.8895, that is.
category
Same as ondansetron hydrochloride.
specification
Based on C18H19N30 (l)2ml:4mg (2)4ml:8Mg
storage
shade, close, and store in a cool place.
Last Update：2022-01-01 15:06:13
