DIGOXIN

DIGOXIN - Names and Identifiers

Name	Digoxin
Synonyms	DIGACIN DIGOXIN LANOXIN Digoxin Lanoxin LANACORDIN DIGOXIN, AP Digoxin (FDA) 12BETA-HYDROXYDIGITOXIN 20(22),5BETA-CARDENOLID-3BETA,12BETA,14BETA-TRIOL 3BETA-2,6-DIDEOXY-4-O-[2,6-DIDEOXY-4-O-(2,6-DIDEOXY-BETA-D-RIBOHEXOPYRANOSYL)-BETA-D-RIBOHEXOPYRANOSIDE] 4-[3-[5-[5-(4,5-DIHYDROXY-6-METHYL-TETRAHYDROPYRAN-2-YL)OXY-4-HYDROXY-6-METHYL-TETRAHYDROPYRAN-2-YL]OXY-4-HYDROXY-6-METHYL-TETRAHYDROPYRAN-2-YL]OXY-12,14-DIHYDROXY-10,13-DIMETHYL-2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17-HEXADECAHYDRO-1H-CYCLOPENTA[A]PHENANTHREN-17-YL]-5H-FURAN-2-ONE
CAS	20830-75-5
EINECS	244-068-1
InChI	InChI=1/C41H64O14/c1-19-36(47)28(42)15-34(50-19)54-38-21(3)52-35(17-30(38)44)55-37-20(2)51-33(16-29(37)43)53-24-8-10-39(4)23(13-24)6-7-26-27(39)14-31(45)40(5)25(9-11-41(26,40)48)22-12-32(46)49-18-22/h12,19-21,23-31,33-38,42-45,47-48H,6-11,13-18H2,1-5H3/t19-,20-,21-,23-,24+,25-,26?,27?,28+,29+,30+,31-,33+,34+,35+,36-,37-,38-,39+,40+,41+/m1/s1

DIGOXIN - Physico-chemical Properties

Molecular Formula	C41H64O14
Molar Mass	780.95
Density	1.1110 (rough estimate)
Melting Point	248 °C
Boling Point	661.93°C (rough estimate)
Specific Rotation(α)	25Hg +13.4 to 13.8° (c = 10 in pyridine)
Flash Point	9℃
Water Solubility	46.08mg/L(room temperature)
Solubility	Soluble in dimethyl sulfoxide and methanol.
Vapor Presure	0mmHg at 25°C
Appearance	powder
Color	White to Almost white
Merck	14,3167
BRN	77011
pKa	13.50±0.70(Predicted)
Storage Condition	Refrigerator
Refractive Index	12 ° (C=10, Pyridine
Physical and Chemical Properties	White Crystal or crystalline powder, odorless, bitter taste. Mp-240 ° C (decomposition), than the optical rotation [alpha] 25Hg +13.4 °-+13.8 °(10%, pyridine), this product has the maximum absorption of sulfuric acid solution at 390nm wavelength. Almost insoluble in water, ethanol, ether, acetone, ethyl acetate and chloroform, soluble in boiling ethanol, pyridine (1:4), chloroform and ethanol mixture. Highly toxic, LD50 (rat, oral) 11 mg/kg.

DIGOXIN - Risk and Safety

Risk Codes	R25 - Toxic if swallowed R26/27/28 - Very toxic by inhalation, in contact with skin and if swallowed. R23/25 - Toxic by inhalation and if swallowed. R39/23/24/25 - R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R11 - Highly Flammable R28 - Very Toxic if swallowed R26 - Very Toxic by inhalation
Safety Description	S22 - Do not breathe dust. S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36/37 - Wear suitable protective clothing and gloves. S16 - Keep away from sources of ignition. S28A -
UN IDs	UN 3462 6.1/PG 2
WGK Germany	3
RTECS	IH6125000
FLUKA BRAND F CODES	3-10
TSCA	Yes
HS Code	29389090
Hazard Class	6.1
Packing Group	II

DIGOXIN - Nature

Open Data Verified Data

The molecule of digitoxin is a steroidal glycoside. It is mainly found in the leaves of digitalis, and the secretions of toads also contain digitoxin. Digitoxin is white or pale yellow crystalline powder, melting point 256~257 ℃. Soluble in acid, chloroform, acetone and pyridine, water-soluble and petroleum ether. Odorless and bitter-free. Crystals obtained from an aqueous solution of ethanol usually contain half or one water of crystallization or one molecule of ethanol, which can be converted to anhydrous by heating to 118 °c in vacuo.

Last Update：2024-01-02 23:10:35

DIGOXIN - Preparation Method

Open Data Verified Data

digitalis leaves are usually used as the raw material for extraction.

Last Update：2022-01-01 11:15:14

DIGOXIN - Standard

Authoritative Data Verified Data

This product is 3B-[O-2, 6-dideoxy-B-D-nuclear-hexopyranosyl-(l-4)-2, 6-dideoxy-B-D-nuclear-hexopyranosyl-(l-4)-2, 6-dideoxy-B-D-nuclear-hexopyranosyl] OxO]-12B, 14b-dihydroxy-5b-xinstay -20(22) enolactone. Calculated as dried product, the content of C41H64014 shall not be less than 95.0%.

Last Update：2024-01-02 23:10:35

DIGOXIN - Trait

Authoritative Data Verified Data

This product is white crystal or crystalline powder; Odorless.
This product is soluble in pyridine, slightly soluble in dilute alcohol, slightly soluble in three gas methane, insoluble in water or ether.

specific rotation

take this product, precision weighing, plus pyridine dissolved and quantitative dilution to make about 20mg solution per lml, according to the law (General 0621), the specific rotation was 9.5 ° to 12.0 °.

Last Update：2022-01-01 11:43:30

DIGOXIN - Use

Open Data Verified Data

can enhance myocardial contractility, slow heart rate and inhibit conduction. It is suitable for long-term use in patients with chronic heart failure.

Last Update：2022-01-01 11:15:15

DIGOXIN - Differential diagnosis

Authoritative Data Verified Data

take about 1 mg of this product, place it in a small test tube, add glacial acetic acid containing ferric oxide (take 10ml of glacial acetic acid and add 1 drop of ferric chloride test solution) and dissolve it in 1 ml. Slowly add 1 ml of sulfuric acid along the tube wall, two liquid layers were formed, and the junction was Brown; After placement, the upper layer was indigo blue.
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 139).

Last Update：2022-01-01 11:43:31

DIGOXIN - Exam

Authoritative Data Verified Data

clarity of the solution

take an appropriate amount of this product, add methanol-chloroform (1:1) dissolved and diluted into a 0.5% solution, should be clarified.

Related substances

take an appropriate amount of this product, accurately weigh it, add dilute ethanol to dissolve and quantitatively dilute it to make a solution containing about 1 mg per 1 ml, which is used as a test solution. Take 2ml for precision measurement, set in a 100ml measuring flask, dilute to the scale with dilute ethanol, and shake to serve as a control solution. Another reference sample of digoxigenin was carefully weighed, dissolved with dilute ethanol and quantitatively diluted to prepare a solution containing about 0.02mg per 1 ml as a reference solution. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution, the control solution and the reference solution are respectively injected into the liquid chromatograph, the chromatogram was recorded to 3 times of the retention time of the main component peak. If there are any peaks in the chromatogram of the test solution that are consistent with the retention time of digoxigenin peak, the content of digoxigenin shall not exceed 2.0% based on the peak area calculated by external standard method; the Peak area of other individual impurities shall not be greater than the main peak area of the control solution (2.0%), and the total amount of impurities shall not exceed 4.0%.

loss on drying

take this product and dry under reduced pressure at 105°C for 1 hour, and the weight loss shall not exceed 1.0% (General rule 0831).

Last Update：2022-01-01 11:43:32

DIGOXIN - 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 filler, acetonitrile-water (10:90) was used as mobile phase A, acetonitrile-water (60:40) was used as mobile phase B; the gradient elution was carried out as follows; The detection wavelength was 230nm; The flow rate was 1.5 per minute. The number of theoretical plates is not less than 2000 calculated from the digoxin peak.

assay

take the right amount of this product, precision weighing, dilute ethanol dissolution and quantitative dilution made in each lml containing about 0.lmg solution was used as the test solution, and 20 u1 was accurately measured. Human liquid chromatograph was used to record the chromatogram. According to the external standard method to calculate the peak area, that is.

Last Update：2022-01-01 11:43:33

DIGOXIN - Category

Authoritative Data Verified Data

cardiotonic drugs.

Last Update：2022-01-01 11:43:33

DIGOXIN - Storage

Authoritative Data Verified Data

sealed storage.

Last Update：2022-01-01 11:43:33

DIGOXIN - Digoxin oral solution

Authoritative Data Verified Data

This product contains digoxin (C41H64014) should be labeled the amount of 90.0% ~ 110.0%.

trait

This product is a yellowish clear liquid with a slight taste.

identification

take 5ml of this product, concentrate it to 1ml, put it in a small tube, add ferric chloride glacial acetic acid solution (take 10ml of glacial acetic acid, add 1 drop of ferric chloride test solution) lml, shake, lml sulfuric acid was slowly added along the pipe wall to form two liquid layers, which were Brown at the junction; After placement, the upper layer was indigo blue.
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.

examination

Related Substances: take this product as the test solution; Take an appropriate amount of the reference sample of digitoxin, add dilute ethanol to dissolve and quantitatively dilute to make a solution containing 50ug per 1 ml, as a stock solution of the reference substance, an appropriate amount was quantitatively diluted with dilute ethanol to prepare a solution containing lug per 1 ml as a reference solution. Another 1 ml of the test solution was taken, and the reference stock solution 20 u1 was added. Silica gel bonded with eighteen alkyl silane was used as filler, acetonitrile-water (10:90) was used as mobile phase A, acetonitrile-water (60:40) was used as mobile phase, as determined by high performance liquid chromatography (General rule 0512). Mobile Phase B; Gradient elution was performed as follows; Detection wavelength was 230nm. The flow rate was 1.5 per minute. The system applicable solution 100u1 was injected into the human liquid chromatograph, and the chromatogram was recorded. The separation degree of digitoxin peak and adjacent auxiliary peaks should meet the requirements. Then l00ul of the test solution and the reference solution were accurately measured and injected into the human liquid chromatograph respectively, and the chromatograms were recorded. If there is a peak in the chromatogram of the test solution that is consistent with the retention time of the digoxigenin peak, the peak area shall be calculated according to the external standard method, and 2.0% of the labeled amount of digoxin shall not be passed.
take 3ml of the product for precise measurement of residual solvent, put the sample into the bottle in the headspace, and seal it as a sample solution; Take an appropriate amount of methanol for precise measurement, A solution containing 0.5 U1 per 1 ml was prepared by dilution with water, and 3ml was precisely weighed. The solution was placed in a headspace injection bottle and sealed as a reference solution. In addition, 3ml of the reference solution was accurately measured, and 0.3ml of ethanol was added to the headspace injection bottle, and the sealed solution was used as the system applicable solution. According to the determination method of residual solvent (General 0861 second method), the capillary column with polyethylene glycol (PEG-20M) as stationary liquid was used as the column. The starting temperature was 40°C, maintained for 5 minutes, and the temperature was raised to 220°C at a rate of 25°C per minute for 2 minutes; The inlet temperature was 150°C, and the detector temperature was 200°C. The Headspace bottle equilibration temperature was 85°C and the equilibration time was 20 minutes. The Headspace sampling of the applicable solution of the system is taken, and the separation degree of methanol peak and ethanol peak shall meet the requirements. The test solution and the reference solution are respectively sampled by Headspace injection, and the chromatogram is recorded. The residual amount of methanol shall not exceed 0.05% by peak area calculation according to external standard method.
the ethanol content of this product shall be 0711-9.0% as determined by the ethanol content determination method (General 11.0%).
others should comply with the relevant provisions under the item of oral solution (General rule 0123).

Content determination

measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Acetonitrile-water (32:68) as mobile phase; The detection wavelength was 230nm. The number of theoretical plates is not less than 2000 calculated from the digoxin peak.
determination precision: take 5ml of this product, put it in a 25ml measuring flask, dilute it to the scale with dilute alcohol, shake it, and take the continued filtrate as the test solution, A 20ul injection liquid chromatograph was used to record the chromatogram. Another reference substance of digoxin was added, dissolved and quantitatively diluted to make a solution containing lOug per lml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.

specification

(1) 10ml: 0.5mg (2)30ml:1.5mg(3)100ml:5mg

storage

sealed storage.

Last Update：2022-01-01 11:43:34

DIGOXIN - Digoxin tablets

Authoritative Data Verified Data

This product contains digoxin (C41H64014) should be labeled the amount of 90.0% ~ 110.0%.

trait

This product is white tablet.

identification

take an appropriate amount of fine powder of this product (about 0.25mg of digoxin), and add 1 ml of glacial acetic acid containing ferric chloride (take 10ml of glacial acetic acid and add 1 drop of ferric chloride solution), shake for several minutes, the filtrate was placed in a small test tube through a vertical melting glass funnel. lml sulfuric acid was slowly added along the tube wall to make two liquid layers, which were Brown at the junction.
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.

examination

Related Substances: take an appropriate amount of fine powder of this product (about equivalent to 10 mg of digoxin), and place it in a plug Erlenmeyer flask. Add 10ml of dilute ethanol into the flask, and close the flask, ultrasound for about 30 minutes to dissolve digoxin, cool, shake well, filter, take the filtrate as a test solution; Take 2ml of precision, put it in a 100ml measuring flask, dilute with dilute ethanol to the scale, shake, as a control solution; Take the reference substance of digitoxin, precision weighing, dilute ethanol solution and quantitative dilution to prepare a solution containing 0.02mg per 1 ml, as a control solution. Determination according to the method under digoxin related substances. If there is a chromatographic peak in the chromatogram of the test solution which is consistent with the retention time of digoxigenin peak, the content of digoxigenin shall not exceed 2.0% of the labeled amount of digoxigenin calculated by the peak area according to the external standard method; the Peak area of other single impurities (except the peak before relative retention time 0.25) shall not be greater than the main peak area of the control solution (2.0% ) , and the total amount of impurities shall not exceed 4.0%.
Content uniformity take 1 tablet of this product, put it in a 25ml measuring flask, add 10ml of water, shake to disintegrate, add 10ml of ethanol, shake well, sonicate for about 30 minutes to dissolve digoxin, dilute with dilute ethanol to the scale, shake well, filter through a filter membrane (the pore size should not be greater than 0.45um), and take the continuous filtrate as the test solution, A solution containing lOug per 1 ml was prepared by dissolving and quantitatively diluting with dilute ethanol as a control solution. The content was determined according to the method under the content determination item. Except for the limit of ± 20%, the provisions (General 0941) shall be met.
the dissolution of this product, according to the dissolution and release determination method (General rule 0931 third method), with water as the dissolution medium, the speed is 100 rpm, according to the law, after 60 minutes, the solution was filtered through a filter membrane, and the filtrate was taken as the test solution; The other precision scale was about 12.5mg of the reference substance, and the solution was placed in a 100ml measuring flask, and the appropriate amount of dilute ethanol was added, shake to dissolve and dilute to the scale, shake well, take an appropriate amount of precision, quantitative dilution with water to prepare a solution containing about lug per 1 ml, as a reference solution. l00ul of each of the test solution and the reference solution was accurately measured, and the dissolution amount of each tablet was calculated according to the chromatographic conditions under the content determination item. The limit is 65% 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

measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Acetonitrile-water (32:68) as mobile phase; Column temperature was 30 ° C.; Detection wavelength was 230nm. The number of theoretical plates is not less than 1500 calculated from the digoxin peak.
determination Method: Take 20 tablets of this product, precise weighing, fine grinding, precise weighing to take an appropriate amount (about 2.5 mg equivalent to digoxin), put it in a 25ml measuring flask, and add an appropriate amount of dilute ethanol, ultrasound for about 30 minutes to dissolve digoxin, cool, dilute to the scale with dilute ethanol, shake well, filter, take the filtrate as the test solution, and take 20 u1 with precision, note human liquid chromatograph, record chromatogram; Another reference substance of digoxin, precision weighing, plus dilute ethanol dissolution and quantitative dilution to make about 0 per 1 ml. lmg solution, the same method for determination. According to the external standard method to calculate the peak area, that is.

specification

0.25mg

storage

sealed storage.

Last Update：2022-01-01 11:43:35

DIGOXIN - Digoxin injection

Authoritative Data Verified Data

This product is a sterile aqueous solution of digoxin. The content of digoxin (C41H64014) shall be between 90.0% and 110.0% of the labeled amount.

trait

This product is colorless or almost colorless clear liquid.

identification

1 ml of this product (about 0.25mg equivalent to digoxin) was placed in a small test tube, and the same reaction was shown according to item (1) of digoxin identification test.
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.

examination

the pH value should be 6.5 to 7.5 (General 0631).
bacterial endotoxin this product, according to the law to check (General 1143), per 1 mg of digoxin containing endotoxin should be less than 200EU.
others should comply with the relevant provisions under injection (General 0102).

Content determination

determined by high performance liquid chromatography (General 0512),
chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Acetonitrile-water (32:68) as mobile phase; Column temperature was 30 ° C.; Detection wavelength was 230nm. The number of theoretical plates is not less than 1500 calculated from the digoxin peak.
measurement precision: take 2ml of this product, which is about 0.5mg of digoxin), put it in a 5ml measuring flask, dilute it to the scale with dilute ethanol, shake it well, and use it as a test solution, take 20 u1 accurately, inject human liquid chromatograph, record chromatogram; Take appropriate amount of digoxin reference substance accurately, dissolve and quantitatively dilute with dilute ethanol to make about 0 digoxin per 1 ml. lmg solution, the same method for determination. According to the external standard method to calculate the peak area, that is.

specification

2ml:0.5mg

storage

light shielding, closed storage.

Last Update：2022-01-01 11:43:36

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Hubei YoungXin Pharmaceutical Tech Co.,Ltd.

Spot supply

Product Name: *Digoxin Visit Supplier Webpage Request for quotation
CAS: 20830-75-5
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052

Wechat: 15671228036

Hefei TNJ Chemical Industry Co.,Ltd.

Product Name: Digoxin Request for quotation
CAS: 20830-75-5
Tel: 0086-551-65418684
Email: sales@tnjchem.com
　　　　 info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840

Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog

View History

DIGOXIN

DIGOXIN Request for Quotation

Digoxin

CAS: 20830-75-5

Molecular Formula: C41H64O14

DIGOXIN - Names and Identifiers

DIGOXIN - Physico-chemical Properties

DIGOXIN - Risk and Safety

DIGOXIN - Nature

Open Data Verified Data

DIGOXIN - Preparation Method

Open Data Verified Data

DIGOXIN - Standard

Authoritative Data Verified Data

DIGOXIN - Trait

Authoritative Data Verified Data

specific rotation

DIGOXIN - Use

Open Data Verified Data

DIGOXIN - Differential diagnosis

Authoritative Data Verified Data

DIGOXIN - Exam

Authoritative Data Verified Data

clarity of the solution

Related substances

loss on drying

DIGOXIN - Content determination

Authoritative Data Verified Data

chromatographic conditions and system suitability test

assay

DIGOXIN - Category

Authoritative Data Verified Data

DIGOXIN - Storage

Authoritative Data Verified Data

DIGOXIN - Digoxin oral solution

Authoritative Data Verified Data

trait

identification

examination

Content determination

category

specification

storage

DIGOXIN - Digoxin tablets

Authoritative Data Verified Data

trait

identification

examination

Content determination

category

specification

storage

DIGOXIN - Digoxin injection

Authoritative Data Verified Data

trait

identification

examination

Content determination

category

specification

storage

Supplier List

DIGOXIN