indaparnide
indapamide
CAS: 26807-65-8
Molecular Formula: C16H16ClN3O3S
indaparnide - Names and Identifiers
| Name | indapamide |
| Synonyms | lozol s1520 ipamix damide tandix fludex bajaten indamol noranat se-1520 natrilix indaflex INDAPAMID Indapamide indapamide INDAPAMIDE Indapamidum indaparnide N-(4-CHLORO-3-SULFAMOYLBENZAMIDO)-2-METHYLINDOLINE 1-(4-chloro-3-sulfamoylbenzamido)-2-methylindoline N-(4-chloro-3-sulfamoylbenzamido)-2-methylindoline N-[4-CHLORO-3-SULFAMOYL-BENZAMIDOL]-2-METHYLINDOLINE N-[4-chloro-3-sulfamoyl-benzamidol]-2-methylindoline 4-chloro-n-(2-methyl-1-indolinyl)-3-sulfamoylbenzamide 4-chloro-n-(2-methyl-1-indolinyl)-3-sulfamoyl-benzamid 4-chloro-N-(2-methyl-2,3-dihydro-1H-indol-1-yl)-3-sulfamoylbenzamide 3-(aminosulfonyl)-4-chloro-n-(2,3-dihydro-2-methyl-1h-indol-1-yl)benzamide 3-(aminosulfonyl)-4-chloro-n-(2,3-dihydro-2-methyl-1h-indol-1-yl)-benzamid |
| CAS | 26807-65-8 |
| EINECS | 248-012-7 |
| InChI | InChI=1/C16H16ClN3O3S/c1-10-8-11-4-2-3-5-14(11)20(10)19-16(21)12-6-7-13(17)15(9-12)24(18,22)23/h2-7,9-10H,8H2,1H3,(H,19,21)(H2,18,22,23) |
| InChIKey | NDDAHWYSQHTHNT-UHFFFAOYSA-N |
indaparnide - Physico-chemical Properties
| Molecular Formula | C16H16ClN3O3S |
| Molar Mass | 365.83 |
| Density | 1.2895 (rough estimate) |
| Melting Point | 160-162°C |
| Boling Point | 110.4°C (rough estimate) |
| Specific Rotation(α) | -0.8～+0.8°(D/20℃) (c=5, C2H5OH) |
| Water Solubility | Soluble in ethanol. Insoluble in water |
| Solubility | Practically insoluble in water, soluble in ethanol (96 per cent). |
| Appearance | neat |
| Color | White to Off-White |
| Merck | 14,4935 |
| pKa | pKa (25°) 8.8 ± 0.2 |
| Storage Condition | -20°C Freezer |
| Refractive Index | 1.6100 (estimate) |
| Use | For the treatment of mild to moderate essential hypertension |
indaparnide - Risk and Safety
| WGK Germany | 2 |
| RTECS | CV2451200 |
| HS Code | 2935904000 |
| Toxicity | LD50 in rats, mice, guinea pigs (mg/kg): 393-421, 410-564, 347-416 i.p.; 394-440, 577-635, 272-358 i.v.; >3000 all species orally (Kyncl) |
indaparnide - Standard
Authoritative Data Verified Data
This product is N-(2-methyl 4, 3-dihydro-1h-indno-1-yl)-3-sulfamoyl-chloro-benzenamine. Calculated as the dried product, the content of C16H16ClN3O3S shall not be less than 98.5%.
Last Update：2024-01-02 23:10:35
indaparnide - Trait
Authoritative Data Verified Data
- This product is white needle-like crystal or crystalline powder; Odorless.
- This product is soluble in acetone and glacial acetic acid, soluble in ethanol or ethyl acetate, slightly soluble in chloroform or ether, almost insoluble in water; Almost insoluble in dilute hydrochloric acid.
melting point
The melting point of this product (General rule 0612) is 162~167 ° C. (the temperature when the meniscus is formed is taken as the total melting temperature).
Last Update：2022-01-01 11:57:09
indaparnide - Differential diagnosis
Authoritative Data Verified Data
- take about 50mg of this product, add 3ml of water, shake, add 0.5 of hydrogen peroxide solution, shake, slightly heat to near boiling, cool, filter, add 3 drops of ferric chloride test solution to the filtrate, shake well, and add 1-2 drops of sodium hydroxide test solution to produce brown-red precipitate.
- take about 50mg of this product, Dropwise add sodium hydroxide solution (0.4- 100) about 1 ~ 2ml, make saturated solution, filter, add 1 drop of copper sulfate test solution to the filtrate, that is, an earthen yellow or brown precipitate is produced.
- 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 infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1275).
Last Update：2022-01-01 11:57:09
indaparnide - Exam
Authoritative Data Verified Data
Related substances
take this product, add an appropriate amount of mobile phase, put it in a hot water bath, shake and dissolve it, then dilute it with mobile phase to make a solution containing about 0.5mg per 1 ml as a test solution; Take an appropriate amount for precision measurement, A solution containing about 5ug per 1 ml was prepared as a control solution by quantitative dilution with mobile phase. According to the chromatographic conditions under the content determination item, 20 u1 of each of the test solution and the control solution are accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram is recorded to 3 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.5 times (0.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%). The chromatogram of the test solution is 0.02 times smaller than the main peak area of the control solution.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 2.4% (General rule 0831).
ignition residue
This product l.O g, inspection according to law (General 0841), residue shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).
Last Update：2022-01-01 11:57:10
indaparnide - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane was used as the filler; Methanol-water-glacial acetic acid (45:55:0.1) was used as the mobile phase; The detection wavelength was 240nm. Take indapamide reference product about 20mg, weigh it accurately, put it in 100ml bottle, add methanol 5ml to dissolve, dilute it with mobile phase to the scale, shake it well, take 5ml, add 2ml of lmol/L sodium hydroxide solution, shake well, heat in water bath for 1 hour, cool down, adjust to Neutral with lmol/L hydrochloric acid solution, dilute to 50ml with mobile phase, shake well, as the system applicable solution, 20u1 was injected into the liquid chromatograph, so that the retention time of the Indapamide peak was about 12 minutes, and the separation degree of the Indapamide peak and the degradation product peak with the relative retention time of about 1.26 should be greater than 6.0.
assay
take about 20mg of this product, accurately weigh it, put it in a 100ml measuring flask, add 5ml of methanol to dissolve it, dilute it to the scale with mobile phase, shake it well, and use it as a stock solution for test; take 10ml accurately, put it in a 50ml measuring flask, dilute it to scale with mobile phase, shake it, and use it as a test solution. Inject 20ul into the liquid chromatograph to record the chromatogram, same method determination. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 11:57:11
indaparnide - Category
Authoritative Data Verified Data
antihypertensive drugs.
Last Update：2022-01-01 11:57:11
indaparnide - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 11:57:11
indaparnide - Indapamide tablets (Natrilix®)
Authoritative Data Verified Data
This product contains indapamide (C16H16CLN303S) should be 90.0% to 110.0% of the label amount.
trait
This product is sugar-coated tablet or film-coated tablet, White after removing the coating.
identification
- take an appropriate amount of fine powder of this product (about 50mg equivalent to indapamide), triturate with acetone 20ml, filter, evaporate the filtrate on a water bath, and identify the residue according to indapamide (1), (2) the test showed the same reaction.
- take 5ml of the test solution under the item of related substances, put it in a 50ml measuring flask, dilute it to the scale with mobile phase, shake it well, and use it as the test solution, add appropriate amount of mobile phase, dissolve in a hot water bath with shaking, and then make a reference solution containing about 50ug per 1 ml of mobile phase, according to the chromatographic conditions under the item of related substances, 20ul of the test solution and the reference solution were respectively taken and injected into the human liquid chromatograph. 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.
examination
- relevant substances: Take appropriate amount of fine powder of this product, add appropriate amount of mobile phase, shake in hot water bath for 5 minutes to dissolve Indapamide, dilute with mobile phase to make a solution containing about 0.5mg of indapamide per 1 ml, filter, the filtrate was taken as the test solution; An appropriate amount was taken in a precise amount and quantitatively diluted with the mobile phase to prepare a solution containing about 5ug of indapamide per 1 ml as a control solution. According to the method of indapamide related substances. The sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%). The chromatogram of the test solution is 0.02 times smaller than the main peak area of the control solution.
- Content uniformity: Take 1 tablet of this product, put it in a mortar, add an appropriate amount of ethanol, grind it, and transfer it to a 100ml measuring flask with ethanol, shake it to dissolve indapamide, add ethanol to dilute to the scale, shake, filter, take a precise amount of filtrate 10ml, put it in a 50ml measuring flask, add ethanol to dilute to the scale, shake, as a test solution. Take the test solution and the reference solution under the content determination item, measure the absorbance at the wavelength of 242nm by ultraviolet-visible spectrophotometry (General rule 0401), calculate the content, the provisions shall be met (General rule 0941).
- dissolution the dissolution of this product was determined according to the dissolution and release determination method (General rule 0931 method 1), and the dissolution medium was 6.8 phosphate buffer (pH 100), and the rotation speed was rpm, operate according to law, after 45 minutes, take the solution filtration, take the filtrate, according to UV-visible spectrophotometry (General 0401), at the wavelength of 240mn absorbance; in addition, take indapamide 25mg accurately, put it in 50ml measuring flask, add methanol to dissolve and dilute to the scale, shake well; Take 5ml accurately, put it in 50ml measuring flask, dilute to the scale with phosphate buffer (pH 6.8) and shake well; Take 5ml accurately, put it in a 100ml measuring flask, dilute to the scale with phosphate buffer (pH 6.8) and shake well, the dissolution amount of each tablet was calculated by the same method. The limit is 75% 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 an appropriate amount (about 5mg equivalent to indapamide), put it in a 100ml measuring flask, add an appropriate amount of ethanol, fully shake to dissolve Indapamide, dilute to scale with ethanol, shake well, filter, Take 5ml of continuous filtrate precisely, put it in 50ml measuring flask, dilute to scale with ethanol, shake well, according to UV-visible spectrophotometry (General rule 0401), measure absorbance at the wavelength of 242nm; Take appropriate amount of indapamide reference substance, ethanol was added to dissolve and quantitatively diluted to prepare a solution containing about 5ug per lml, which was determined and calculated by the same method.
category
Same as indapamide.
specification
2.5mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:57:12
indaparnide - Indapamide capsules
Authoritative Data Verified Data
This product contains indapamide (C16H16C1N303S) should be 90.0% to 110.0% of the label amount.
trait
The content of this product is white or white particles or powder.
identification
- take an appropriate amount of the contents of this product (about equivalent to indapamide lOOmg), add acetone 40ml, grind, filter, the filtrate is evaporated on a water bath, take an appropriate amount of residue, add 3ml of water, shake, add 0.5 of hydrogen peroxide solution, shake, slowly heat to near boiling, cool, filter, add 3 drops of ferric hydride solution, shake well, add 1-2 drops of sodium hydroxide solution, A brown-red precipitate was produced.
- take an appropriate amount of residue under Item (1) of identification, add about 1-2ml of sodium hydroxide solution (0.4-100), make a saturated solution, filter, add 1 drop of copper sulfate test solution to the filtrate, that is, an earthen yellow or brown precipitate is produced.
- take 5ml of the test solution under the item of related substances, put it in a 50ml measuring flask, dilute it to the scale with mobile phase, shake it well, and use it as the test solution, add appropriate amount of mobile phase, dissolve in hot water bath with shaking, dilute with mobile phase to make solution containing about 50ug per 1 ml as reference solution, and adjust the chromatographic conditions under related substances, 20 u1 of the test solution and the reference solution are injected into the liquid chromatograph respectively, and the chromatogram is recorded. 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.
examination
- appropriate amount of fine powder under the content determination item of related substances is taken, appropriate amount of mobile phase is added, and Indapamide is dissolved by shaking in a hot water bath, and then diluted with mobile phase to prepare a solution containing about 0.5mg of indapamide per 1 ml, the filtrate was filtered and taken as a test solution; An appropriate amount was taken in a precise amount and quantitatively diluted with mobile phase to prepare a solution containing about 5ug of indapamide per 1 ml as a control solution. According to the method of indapamide 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%). The chromatogram of the test solution is 0.02 times smaller than the main peak area of the control solution.
- Content uniformity: Take 1 capsule of this product, pour out the contents into a mortar, grind it, and transfer it to a 100ml measuring flask in fractions with ethanol. Rinse the capsule shell with a small amount of ethanol, wash it and put it in a measuring flask, shake, dissolve Indapamide, dilute to the scale with ethanol, shake well, filter, take the filtrate accurately, put 5mh into a 25ml measuring flask, dilute to the scale with ethanol, shake well, determination of content according to the method under the content determination item, should comply with the provisions (General 0941).
- dissolution the dissolution of this product was determined according to the dissolution and release determination method (General rule 0931 method 1), and the dissolution medium was 6.8 phosphate buffer (pH 100), and the rotation speed was rpm, operate in accordance with the law, after 45 minutes, take 10ml solution, filter, take the filtrate, according to the method under the content determination of absorbance; Another precision weighing indapamide reference about 10mg, in a 200ml measuring flask, add 10ml of ethanol to dissolve, dilute to scale with dissolution medium, shake well, take 5ml accurately, put it in a 100ml children's bottle, dilute to scale with dissolution medium, shake, the same method to calculate the amount of each dissolution. The limit is 70% of the labeled amount and shall be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
take the contents of 20 capsules of this product, precision weighing, calculate the average loading, take the contents of fine grinding, mixing, precision weighing appropriate amount (about 5mg equivalent to indapamide), add appropriate amount of ethanol to the 100ml measuring flask, fully shake to dissolve Indapamide, dilute with ethanol to the scale, shake well, filter, Take 5ml of continuous filtrate, put it in the 50ml measuring flask, dilute with ethanol to scale, shake well, measure absorbance at the wavelength of 242nm according to UV-Vis spectrophotometry (General rule 0401); Take appropriate amount of indapamide reference substance by precision weighing, ethanol was added to dissolve and quantitatively diluted to prepare a solution containing about 5ug per lml, which was determined and calculated by the same method.
category
Same as indapamide.
specification
2.5mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:57:13
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CAS: 26807-65-8
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CAS: 26807-65-8
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CAS: 26807-65-8
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