1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecoticacidethylester
Diphenoxylate
CAS: 915-30-0
Molecular Formula: C30H32N2O2
1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecoticacidethylester - Names and Identifiers
| Name | Diphenoxylate |
| Synonyms | diphenoxylate DIPHENOXYLATE Diphenoxylate HCl 2,2-diphenyl-4-(4-carbethoxy-4-phenylpiperidino)butyronitrile 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecoticacidethylester 1-(3-cyano-3,3-diphenylpropyl)-4-phenyl-isonipecoticaciethylester 1-(3-cyano-3,3-diphenylpropyl)-4-phenyl-isonipecoticacidethylester ethyl1-(3-cyano-3,3-diphenylpropyl)-4-phenyl-4-piperidinecarboxylate ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylpiperidine-4-carboxylate 1-(3-cyano-3,3-diphenylpropyl)-4-phenyl-4-piperidinecarboxylicaciethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenyl-4-piperidinecarboxylicacidethylester |
| CAS | 915-30-0 |
| EINECS | 213-020-1 |
| InChI | InChI=1/C30H32N2O2/c1-2-34-28(33)29(25-12-6-3-7-13-25)18-21-32(22-19-29)23-20-30(24-31,26-14-8-4-9-15-26)27-16-10-5-11-17-27/h3-17H,2,18-23H2,1H3 |
1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecoticacidethylester - Physico-chemical Properties
| Molecular Formula | C30H32N2O2 |
| Molar Mass | 452.59 |
| Density | 1.123±0.06 g/cm3(Predicted) |
| Boling Point | 602.3±55.0 °C(Predicted) |
| pKa | pKa 7.1 (Uncertain) |
| Use | Antidiarrheal for acute and chronic functional diarrhea and chronic enteritis |
1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecoticacidethylester - Risk and Safety
| Hazard Symbols | T+ - Very toxic |
| Risk Codes | R26/27/28 - Very toxic by inhalation, in contact with skin and if swallowed. R42/43 - May cause sensitization by inhalation and skin contact. |
| Safety Description | S22 - Do not breathe dust. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) |
| Toxicity | Diphenoxylate is an antiperistaltic, antidiarrheal drug that is also listed as a controlled substance (opiate). |
1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecoticacidethylester - Standard
Authoritative Data Verified Data
This product is l- (3, 3-diphenyl-3-oxopropyl)-4-phenyl -4-vein carboxylic acid ethyl ester hydrochloride. The content of C10H32N202 • HCl shall not be less than 98.0% calculated on a dry basis.
Last Update：2024-01-02 23:10:35
1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecoticacidethylester - Trait
Authoritative Data Verified Data
- This product is white or off-white powder or crystalline powder; Odorless.
- This product is soluble in chloroform, dissolved in methanol, slightly soluble in ethanol or acetone, almost insoluble in water or ether.
melting point
The melting point of this product (General rule 0612 first method) is 221~226°C.
Last Update：2022-01-01 14:22:36
1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecoticacidethylester - Differential diagnosis
Authoritative Data Verified Data
- take this product, add lmol/ L hydrochloric acid solution-methanol (1:99) to make a solution containing mg per lml, according to UV-visible spectrophotometry (General rule 0401) the maximum absorption was measured at 252nm, 258nm and 264nm wavelengths. The absorbance ratio at 258nm to 252nm should be between 1.1 and 1.3.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 339).
- this product of saturated aqueous solution chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 14:22:37
1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecoticacidethylester - Exam
Authoritative Data Verified Data
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).
ignition residue
not more than 0.1% (General rule 0841).
Last Update：2022-01-01 14:22:37
1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecoticacidethylester - Content determination
Authoritative Data Verified Data
take this product about 0.4g, precision weighing, add glacial acetic acid 20ml and Mercury acetate test solution 5ml, shake to dissolve, add crystal violet indicator solution 1 drop, with perchloric acid titration solution (0.1 mol/L) titration to a blue color of the solution, and the results of the titration were corrected by a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 48.91mg of C30H32N2O2 · hc1.
Last Update：2022-01-01 14:22:38
1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecoticacidethylester - Category
Authoritative Data Verified Data
antidiarrheal drugs.
Last Update：2022-01-01 14:22:38
1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecoticacidethylester - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 14:22:38
1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecoticacidethylester - Compound Diphenoxylate Tablets
Authoritative Data Verified Data
each tablet of diphenoxylate hydrochloride (C30H32N202 • HC1) should be 2.25~2.75mg; Atropine sulfate [(C17H23N03 )2 • H2S04 • H20] should be 20.0~30.0ug.
prescription
diphenoxylate hydrochloride 2.5G
Atropine sulfate 25Mg
Appropriate amount of excipients
prepared 1000 tablets
trait
This product is white tablet.
identification
In the chromatograms recorded under the content determination of diphenoxylate hydrochloride and atropine sulfate, 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.
examination
- Content uniformity diphenoxylate hydrochloride take 1 tablet of this product, put it in a mortar, grind it finely, add the appropriate amount of mobile phase under the item of diphenoxylate hydrochloride content determination, grind it, and transfer the mobile phase to a 50ml measuring flask in portions, shake to dissolve diphenoxylate hydrochloride, dilute to the scale with mobile phase, shake well, filter, and take the filtrate to determine the content of diphenoxylate hydrochloride by the method under the item of determination of diphenoxylate hydrochloride, which shall comply with the regulations (General rule 0941)..
- atropine sulfate take 1 tablet of this product, put it in mortar, grind it finely, add the appropriate amount of mobile phase under atropine sulfate content determination, grind it, and transfer the mobile phase to 25ml measuring flask in fractions, shake to dissolve atropine sulfate, dilute to scale with mobile phase, shake well, filter, take filtrate 50 u1, determine according to the method under the content determination of atropine sulfate; in addition, take an appropriate amount of atropine sulfate reference substance, weigh it precisely, add the mobile phase to dissolve and quantitatively dilute it to make a solution containing about 1 ml per 1 ml, and determine with the same method, calculate with peak area according to external standard method, and the limit is ± 20%, the provisions shall be met (General rule 0941).
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
- diphenoxylate hydrochloride was measured by HPLC (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Triethylamine phosphoric acid solution (take triethylamine 4ml, add water 500ml, phosphoric acid 2ml, add water to 1000ml, mix well)-Acetonitrile (45:55), and adjust pH to 3.1±0.2 as mobile phase; Detection wavelength was 230nm. The number of theoretical plates is not less than 2000 based on the peak of diphenoxylate.
- determination of 50 tablets of this product, precision weighing, fine, precision weighing an appropriate amount (about 2.5mg equivalent to diphenoxylate hydrochloride), put in a 50ml measuring flask, add an appropriate amount of mobile phase, fully shake to dissolve diphenoxylate hydrochloride, dilute to the scale with mobile phase, shake, filter, take the filtrate as the test solution, accurately measure 20ul injection liquid chromatograph, record the chromatogram. Another appropriate amount of diphenoxylate hydrochloride reference substance was accurately weighed, dissolved and quantitatively diluted with mobile phase to make a solution containing about 50ug per 1ml, and the same method was used for determination. According to the external standard method to calculate the peak area, that is.
- atropine sulfate was measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system applicability test using eighteen alkyl silane bonded silica gel as filler; Triethylamine phosphoric acid solution (4ml of triethylamine, 500ml of water, 1.8ml of induced acid, 1000ml of water, mixed with acetonitrile (85:15), and adjust the pH value to 5.8±0.2 as mobile phase; The detection wavelength was 206nm. The number of theoretical plates shall not be less than 3000 calculated from the peak of atropine sulfate.
- determination Method: Take the above fine powder, weigh appropriately (about 0.5mg of atropine sulfate), put it in a 50ml measuring flask, add appropriate amount of mobile phase, and fully shake to dissolve atropine sulfate, dilute to the scale with mobile phase, shake, filter, take the continued filtrate as the test solution, take the precision of 20u1 injection liquid chromatograph, record the chromatogram. In addition, an appropriate amount of atropine sulfate reference substance was accurately weighed, dissolved and quantitatively diluted with mobile phase to prepare a solution containing about 10ug per lml, and determined by the same method. According to the external standard method, the peak area is calculated, and the result is multiplied by 1.027.
category
antidiarrheal drugs.
storage
sealed storage.
Last Update：2022-01-01 13:43:20
