茶碱乙二胺
Aminophylline
CAS: 317-34-0
Molecular Formula: C9H16N6O2
茶碱乙二胺 - Names and Identifiers
| Name | Aminophylline |
| Synonyms | AMINOPHYLLINE Aminophylline Theophylline-e Aminophylline hydrat aminophyllin hydrate Aminophylline hydrate Aminophylline anhydrous AMinophylline(Phyllocontin, Truphylline) Theophylline-ethylenediaMine anhydrous COS THEOPHYLLINE COMPOUND WITH ETHYLENEDIAMINE Theophylline, compound with ethylenediamine (2 to 1) dihydrate |
| CAS | 317-34-0 |
| EINECS | 206-264-5 |
| InChI | InChI=1/2C7H8N4O2.C2H8N2.H2O/c2*1-10-5-4(8-3-9-5)6(12)11(2)7(10)13;3-1-2-4;/h2*3H,1-2H3,(H,8,9);1-4H2;1H2 |
茶碱乙二胺 - Physico-chemical Properties
| Molecular Formula | C9H16N6O2 |
| Molar Mass | 240.27 |
| Melting Point | 269-270 °C |
| Boling Point | 869.7°C at 760 mmHg |
| Flash Point | 479.8°C |
| Water Solubility | soluble |
| Solubility | Easily soluble in water, insoluble in ethanol or ether |
| Vapor Presure | 2.62E-32mmHg at 25°C |
| Appearance | White to slightly yellow powder or granular |
| Color | white to off-white |
| Merck | 14,465 |
| pKa | pKa 5.0 (Uncertain) |
| Storage Condition | Inert atmosphere,Store in freezer, under -20°C |
| MDL | MFCD00013221 |
| Physical and Chemical Properties | Containing anhydrous theophylline 75%-82%, ethylenediamine 12.3%-13.8%. White or light yellow particles or powder. Slightly ammonia odor. Bitter in taste. Open Air is easy to absorb carbon dioxide and theophylline. Soluble in water, almost insoluble in ethanol or ethanol. The aqueous solution showed alkaline reaction, and turbidity occurred after placing. |
| Use | Mainly used for bronchial asthma and asthma-type chronic bronchitis, can also be used for acute heart failure, cardiac asthma and biliary colic |
茶碱乙二胺 - Risk and Safety
| Risk Codes | R22 - Harmful if swallowed R42/43 - May cause sensitization by inhalation and skin contact. R34 - Causes burns R36/37/38 - Irritating to eyes, respiratory system and skin. R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. |
| Safety Description | S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S23 - Do not breathe vapour. S36 - Wear suitable protective clothing. |
| UN IDs | UN 2811 6.1/PG 3 |
| WGK Germany | 3 |
| RTECS | XH5600000 |
| FLUKA BRAND F CODES | 10-23 |
| TSCA | Yes |
| HS Code | 29339900 |
| Hazard Class | 6.1(b) |
| Packing Group | III |
| Toxicity | LD50 orally in mice: 540 mg/kg (Thompson, Warren) |
茶碱乙二胺 - Standard
Authoritative Data Verified Data
This product is 1, 3-dimethyl-3, 7-dihydro-1 purin-2, 6-diketo-1, 2-ethylenediamine salt dihydrate or anhydrous. Based on the anhydrous content, the content of anhydrous theophylline (C7H8N402) should be 84.0% to 87.4%, and the content of ethylenediamine (C2H8N2) should be 13.5% to 15.0%.
Last Update：2024-01-02 23:10:35
茶碱乙二胺 - Trait
Authoritative Data Verified Data
- This product is white to yellowish particles or powder, easy to agglomerate; Slightly ammonia odor; Absorption of carbon dioxide in the air, and decomposition into theophylline; Aqueous solution alkaline reaction.
- This product is dissolved in water, slightly soluble in ethanol, and almost insoluble in ether.
Last Update：2022-01-01 15:37:18
茶碱乙二胺 - Introduction
, The exposed air gradually absorbs carbon dioxide gas and decomposes or theophylline, slightly smelly and bitter.
Last Update：2022-10-16 17:24:33
茶碱乙二胺 - Differential diagnosis
Authoritative Data Verified Data
- take about 0.2g of this product, Add 10ml of water to dissolve, stir constantly, Dropwise add 1 ml of dilute hydrochloric acid to precipitate theophylline, filter T filter residue after washing with a small amount of water, after drying at 105°C for 1 hour, the infrared absorption pattern should be consistent with that of the control (Spectrum set 272).
- take about 30mg of this product, add 1 ml of water to dissolve, add 2~3 drops of 1% copper sulfate solution, shake, the solution is purple at the beginning; Continue to add copper sulfate solution Dropwise, gradually blue-purple, finally, it turned dark 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.
Last Update：2022-01-01 15:37:18
茶碱乙二胺 - Exam
Authoritative Data Verified Data
clarity and color of solution
take 0.50g of this product, Add 10ml of New boiling and cooling water, slightly heat to dissolve, the solution should be clear and colorless, such as color, inspection according to law (General Principles 0901 first law), compared with the yellow-green No. 2 Standard Colorimetric solution, it should not be deeper.
Related substances
take 0.20g of this product, add 2ml of water, slightly heat to dissolve, cool, dilute with methanol to 10ml, shake, as a test solution; Take 1ml, as a control solution, it was diluted to 200ml with methanol and shaken. According to the thin layer chromatography (General 0502) test, absorb the above two solutions of 10 u1, respectively, on the same silica gel GF254 thin layer plate, with n-butanol-acetone-chloroform-concentrated ammonia solution (40:30:30:10) for the development of the agent, expand, dry, set the UV light (254nm) under the view. Test solution such as impurity spots, compared with the control solution of the main spot, not deeper.
moisture
take this product, according to the moisture determination method (General rule 0832 first method 1), containing water not more than 8.0%; For anhydrous aminophylline [C2H8N2(C7H8N402) 2], water content should not exceed 1.5%.
ignition residue
not more than 0.1% (General rule 0841).
Last Update：2022-01-01 15:37:19
茶碱乙二胺 - Content determination
Authoritative Data Verified Data
- anhydrous Theophylline was measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-0.12% pentane sulfonic acid, sodium solution (20:80)(With glacial acetic acid to adjust the pH value to 2.9 0.1) as mobile phase; The detection wavelength was 254nm. Take appropriate amounts of theophylline control and theobromine control, add methanol-water (1:4) to dissolve and dilute to prepare 0.064mg Solutions per 1 ml, and inject 10ul into the liquid chromatograph, the number of theoretical plates shall not be less than 2000 based on theophylline peak, and the separation degree between theophylline peak and theobromine peak shall be greater than 3.0.
- determination method: take an appropriate amount of this product, weigh it accurately, add methanol-water (1:4) to dissolve and quantitatively dilute to prepare a solution containing 0.08mg of anhydrous theophylline per 1 ml, as a test solution, 10 u1 was accurately measured and injected into the liquid chromatograph to record the chromatogram. Another theophylline reference substance was taken and determined by the same method. According to the external standard method to calculate the peak area, that is.
- ethylenediamine take this product about 0.25g, precision weighing, add water 25ml to dissolve, add 8 drops of sodium alizarin sulfonate indicator solution, with sulfuric acid titration solution (0.05mol/L) the solution was titrated to yellow. Each 1 ml of sulfuric acid titration solution (0.05mol/L) corresponds to 3.005mg of C2H8N2.
Last Update：2022-01-01 15:37:20
茶碱乙二胺 - Category
Authoritative Data Verified Data
smooth muscle relaxants, diuretics.
Last Update：2022-01-01 15:37:20
茶碱乙二胺 - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:37:20
茶碱乙二胺 - Aminophylline tablets
Authoritative Data Verified Data
This product contains anhydrous theophylline (C7H8N402) shall be 74.0% ~ 84.0% of the labeled amount of aminophylline, containing ethylenediamine (C2H8N2) shall not be less than 11.25% of the labeled amount of aminophylline.
trait
This product is white to yellowish.
identification
take an appropriate amount of fine powder of this product (about 0.5g of aminophylline), add water to 20ml, grind and impregnate, filter, and the filtrate shows alkaline reaction; the filtrate was taken and subjected to the test of identification items (1) and (2) under aminophylline, showing the same results.
examination
- Content uniformity (20mg specification) take 1 tablet of this product, put it in a 50ml measuring flask, add 0.1mol/L sodium hydroxide solution 5ml and water 15ml, shake for 10 minutes to dissolve aminophylline, dilute with water to the scale, shake, take appropriate amount of precision, quantitative dilution with 0.01mol/L sodium hydroxide solution to make A solution containing 10ug of aminophylline per 1 ml, determined according to the method under the item of content determination of anhydrous theophylline, A = | 79-X |, the provisions shall be met (General rule 0941).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method), with water as the dissolution medium, the speed is 100 rpm, according to the law, after 10 minutes, take 10ml of the solution for filtration, take the appropriate amount of filtrate with precision, and use 0.Olmol/L sodium hydroxide solution is diluted quantitatively to make a solution containing about 10ug of aminophylline per 1 ml, and the absorbance is measured at the wavelength of 275nm by ultraviolet-visible spectrophotometry (General rule 0401), the elution amount of each tablet was calculated with an absorption coefficient of 650. The limit is 60% 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
- anhydrous theophylline take 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about equivalent to aminophylline lOOmg), put it in a 200ml measuring flask, add 0.1 mol/L sodium hydroxide solution 20ml and water 60ml, shake for 10 minutes to dissolve aminophylline, dilute with water to scale, shake, filter, Take 5ml of continuous filtrate accurately, put it in 250ml measuring flask, use 0.Olmol/L sodium hydroxide solution diluted to the scale, shake, according to UV-visible spectrophotometry (General 0401), at the wavelength of 275nm absorbance, the C2H8N402 absorption coefficient was calculated to be 650.
- ethylenediamine precise weighing appropriate amount of the above-mentioned ground powder (about 0.5g equivalent to aminophylline), adding 50ml of water, slightly warming to dissolve aminophylline, cooling, adding 8 drops of sodium alizarin sulfonate indicator solution, with hydrochloric acid titration solution (0.1 mol/L) titration to the solution showed yellow. Each 1 ml of hydrochloric acid titration solution (0.1 mol/L) corresponds to 3.005mg of C2H8N2.
category
Same as aminophylline.
specification
calculated as C2H8N2(C7H8N4O2)2 • 2H20 (l)20mg(2)30mg (3)100mg (4)200Mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:37:21
茶碱乙二胺 - Aminophylline injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of aminophylline. The content of anhydrous theophylline (C7H8N4O2) shall be 74.0% to 84.0% of the labeled amount of aminophylline, and the content of ethylenediamine (C2H8N2) shall be 13.0% to 20.0% of the labeled amount of aminophylline.
trait
This product is colorless to light yellow clear liquid.
identification
take an appropriate amount of this product, according to aminophylline under the identification of (1), (2) test, showed the same results.
examination
- the pH value should not exceed 9.6 (General rule 0631).
- color of this product, should be colorless; If the color, take appropriate amount, diluted with water to make a solution containing 0.125g of aminophylline per 1 ml, no deeper than the yellow or yellow-green No. 4 standard colorimetric solution (General rule 0901 method 1).
- appropriate amount of related substances should be taken and diluted with mobile phase to prepare a solution containing about 2.5mg of aminophylline per 1ml, which should be used as a sample solution; 1ml should be accurately measured and placed in a 200ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. The appropriate amounts of theophylline control and theobromine control were separately taken, dissolved and diluted with the mobile phase to prepare a solution containing 10ug each in 1ml as a system-applicable solution. According to the test of high performance liquid chromatography (General rule 0512), silica gel bonded with eighteen alkyl silane was used as the filler; Acetate buffer solution (1.36g of sodium acetate was taken, of water was added to dissolve, and 5ml of glacial acetic acid was added, then add water to dilute to 1000ml, shake well)-acetonitrile (93:7) as mobile phase; The detection wavelength is 27lnm; Take the system suitable solution 20ul, inject liquid chromatography, record chromatogram, the number of theoretical plates shall not be less than 5000 based on theophylline peak, and the separation degree between theobromine peak and theophylline peak shall be greater than 2.0. 20 u1 of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 3 times of the retention time of theophylline peak. If there are impurity peaks in the chromatogram of the test solution (except the excipient peak and benzyl alcohol peak before the retention time of theophylline peak is about 0.3), the sum of each impurity peak area shall not be greater than the main peak area of the control solution (0.5%).
- the bacterial endotoxin of this product should be checked according to law (General rule 1143), and the amount of endotoxin in aminophylline should be less than 0.50EU per 1 mg.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- anhydrous theophylline precision take an appropriate amount of this product and quantitatively dilute it with 0.01mol/L sodium hydroxide solution to make a solution containing 10ug of aminophylline per 1 ml, the absorbance was measured at a wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (General rule 650), and the absorption coefficient of C7H8N402 was calculated. Take an appropriate amount of this product (equivalent to 0.25g of aminophylline), add 50ml of water, shake well, add 8 drops of sodium alizarin sulfonate indicator solution, and use hydrochloric acid titration solution (0.1 mol/L) titration to the solution showed yellow. Each 1 ml of hydrochloric acid titration solution (0.1 mol/L) corresponds to 3.005mg of C2H8N2.
category
Same as aminophylline.
specification
calculated as C2H8N2(C7H8N402)2 • 2H20 (l)2ml:0.125g (2)2ml:0.25g (3)2ml:0.5g (4)10ml:0.25g
storage
light shielding, closed storage.
Last Update：2022-01-01 15:37:22
茶碱乙二胺 - Aminophylline and sodium chloride injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of aminophylline and sodium chloride. Containing anhydrous theophylline (C7H8N402) shall be 74.0% ~ 84.0% of the labeled amount of aminophylline, containing ethylenediamine (C2H8N2) shall be 13.0% ~ 20.0% of the labeled amount of aminophylline, containing sodium chloride (NaCl) it shall be between 95.0% and 105.0% of the labeled amount.
trait
This product is colorless to yellowish clear liquid.
identification
- take about 5ml of this product, add 3ml of ammonia-ammonium chloride buffer (pH 8.0), and then add 1ml of copper piracetam solution. After shaking, add 5ml of chloroform, shake, the chloroform layer was green.
- take about 5ml of this product, add 2~3 drops of 1% copper sulfate solution, shake, the solution is purple; Continue to add copper sulfate solution, gradually blue-purple, and finally blue.
- This product shows the reaction of sodium salt identification (1) and chloride identification (1) (General rule 0301).
examination
- the pH value should be 8.0 to 9.5 (General 0631).
- the color of this product, compared with the yellow No. 1 Standard Colorimetric liquid (General Principles 0901 first method), should not be deeper.
- Related substances take this product as the test solution; Take 1 ml with precision, put it in a 200ml measuring flask, dilute it to the scale with mobile phase, shake well, and use it as the control solution; the appropriate amounts of theophylline reference substance and theobromine reference substance were separately taken, dissolved by adding mobile phase, and diluted to prepare 10ug of each one in 1 ml as a system-applicable solution. According to the test of high performance liquid chromatography (General rule 0512), silica gel bonded with dectylosylgerane was used as the filler; Acetic acid buffer solution (sodium acetate L. 36G, add water 100ml to dissolve, add glacial acetic acid 5ml, then dilute to 1000ml with water, shake well)-acetonitrile (93:7) as mobile phase; The detection wavelength is 271nm; Take 20ul of system applicable solution, inject into liquid chromatography, record chromatogram, the number of theoretical plates shall not be less than 5000 based on theophylline peak, and the separation degree between theobromine peak and theophylline peak shall be greater than 2.0. 20 u1 of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 3 times of the retention time of theophylline 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 the main peak area of the control solution (0.5%).
- take 50ml of heavy metal, evaporate to about 3.5, let it cool, add 2ml of acetate buffer (pH 0821) and an appropriate amount of water to make 25ml, and check it according to law (General rule first law), heavy metals should not exceed three million.
- osmolality the osmolality shall be 0632-270 mosmol/kg for determination according to law (general rule).
- bacterial endotoxin take this product, according to the inspection (General 1143), the amount of endotoxin per lml should be less than 0.50 EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- anhydrous theophylline precise quantity take appropriate amount of this product, use O.Olmol/L sodium hydroxide solution is diluted quantitatively to make a solution containing about 10ug of aminophylline per 1 ml, and the absorbance is measured at the wavelength of 275mn by ultraviolet-visible spectrophotometry (General rule 0401), it is obtained by calculating the absorption coefficient of C7H8N402 as 650.
- ethylenediamine precision measure 50ml of this product, add 8 drops of sodium alizarin sulfonate indicator solution, and titrate with hydrochloric acid titration solution (0.lmol/L) until the solution is yellow. Each 1 ml of hydrochloric acid titration solution (0.1 mol/L) corresponds to 3.005mg of C2H8N2.
- sodium chloride precision take this product 10ml, add water 40ml, according to the potential titration method (General 0701), with silver nitrate titration solution (0.lmol/L) titration, the consumption of silver nitrate titration solution (0.1 mol/L) minus the amount of silver nitrate titrant (O. 1 mol/L) the number of milliliters, calculated. Each 1 ml of silver nitrate titration solution (0.1 mol/L) corresponds to 18.02mg of C7H8N402, and each 1 ml of silver nitrate titration solution (0.1 mol/L) corresponds to 5.844mg of NaCl.
category
Same as aminophylline.
specification
100ml: aminophylline [calculated as C2H8N2(C7H8N402 )2 • 2H20] 0.25g with sodium chloride 0.9g
storage
light shielding, closed storage.
Last Update：2022-01-01 15:37:23
茶碱乙二胺 - Aminophylline sustained-release tablets
Authoritative Data Verified Data
This product contains anhydrous theophylline (C7H8N402) shall be 74.0% ~ 84.0% of the labeled amount of aminophylline, containing ethylenediamine (C2H8N2) shall not be less than 11.25% of the labeled amount of aminophylline.
trait
This product is a film-coated tablet, white to yellowish after removing the coating.
identification
take an appropriate amount of fine powder of this product (about 0.5g of aminophylline), add water to 20ml, grind and impregnate, filter, and the filtrate shows alkaline reaction; the filtrate was taken and subjected to the test of identification items (1) and (2) under aminophylline, showing the same reaction.
examination
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), with dilute hydrochloric acid solution (24-1000)1000ml as the dissolution medium, the rotation speed is 50 rpm, operate according to law, take 10ml of the solution at 2 hours, 4 hours and 6 hours respectively, filter, and immediately add 10ml of the dissolution medium to the dissolution Cup; Take 5ml of the continued filtrate respectively, add 0.1 mol/L sodium hydroxide solution 4.5, with 0.Olmol/L sodium hydroxide solution was Diluted quantitatively to make a solution containing aminophylline 10 beer per 1 ml, and then shaken with UV-Vis spectrophotometry (General rule 0401), the absorbance was measured at a wavelength of 275nm, and the elution amount of each tablet at different times was calculated according to the absorption coefficient of C7 H8N40 2 as 650. The dissolution amount of each tablet in 2 hours, 4 hours and 6 hours shall be 25% ~ 45%, 35% ~ 55% and 50% of the labeled amount respectively, and shall comply with the regulations.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
- anhydrous theophylline take 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about equivalent to aminophylline lOOmg), put it in a 200ml measuring flask, add 0.1 mol/L sodium hydroxide solution 20ml and water 60ml, shake to dissolve aminophylline, dilute to the scale with water, shake well, filter, Take 5ml of filtrate and put it in 250ml measuring flask, use 0.Olmol/L sodium hydroxide solution diluted to the scale, shake, according to UV-visible spectrophotometry (General 0401), at the wavelength of 275nm absorbance, it is obtained by calculating the absorption coefficient of C7H8N402 as 650.
- ethylenediamine precision weighing an appropriate amount of the above ground powder (about 0.8g equivalent to aminophylline), placing it in a 100ml measuring flask, adding an appropriate amount of water, slightly warming to dissolve aminophylline, and allowing it to cool, dilute with water to the scale, shake, filter, take the filtrate 50ml, add 8 drops of sodium alizarin sulfonate indicator solution, use hydrochloric acid titration solution (0.1 mol /L) titration to the solution showed yellow. Each 1 ml of hydrochloric acid titration solution (0.1 mol/L) corresponds to 3.005mg of C2H8N2.
category
Same as aminophylline.
specification
calculated as C2H8N2(C7H8N402)2 • 2H20 (1)0.lg(2)0.2g
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:37:24
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Product Name: Aminophylline Visit Supplier Webpage Request for quotationCAS: 317-34-0
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Product Name: Aminophylline Request for quotation
CAS: 317-34-0
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
CAS: 317-34-0
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
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Product Name: Aminophylline hydrate Visit Supplier Webpage Request for quotationCAS: 317-34-0
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Mobile: 18021002903
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