dipivefrinehydrochloride
Dipivefrin hydrochloride
CAS: 64019-93-8
Molecular Formula: C19H30ClNO5
dipivefrinehydrochloride - Names and Identifiers
| Name | Dipivefrin hydrochloride |
| Synonyms | Progate Dipivefrine HCL dipivefrinhydrochloride hydrochloride,(+-)-este Dipivefrin hydrochloride dipivefrinehydrochloride DIPIVEFRIN HYDROCHLORIDE (200 MG) dipivalylepinephrinehydrochloride propanoicacid,2,2-dimethyl-,4-(1-hydroxy-2-(methylamino)ethyl)-1,2-phenylene |
| CAS | 64019-93-8 |
| EINECS | 264-609-5 |
| InChI | InChI=1/C19H29NO5.ClH/c1-18(2,3)16(22)24-14-9-8-12(13(21)11-20-7)10-15(14)25-17(23)19(4,5)6;/h8-10,13,20-21H,11H2,1-7H3;1H |
dipivefrinehydrochloride - Physico-chemical Properties
| Molecular Formula | C19H30ClNO5 |
| Molar Mass | 387.8982 |
| Melting Point | 158-159° |
| Boling Point | 473.7°C at 760 mmHg |
| Flash Point | 240.3°C |
| Solubility | Freely soluble in water, very soluble in methanol, freely soluble in ethanol (96 per cent) and in methylene chloride. |
| Vapor Presure | 8.89E-10mmHg at 25°C |
| Appearance | neat |
| Color | White to Off-White |
| pKa | 8.40(at 25℃) |
| Storage Condition | Hygroscopic, -20°C Freezer, Under inert atmosphere |
| Use | Intraocular pressure lowering agents for the treatment of glaucoma |
| In vivo study | Dipivefrin hydrochloride (0.3-10 μg/kg; i.p.;) induces enhancement of memory involves central beta- but not alpha-adrenergic mechanisms. Animal Model: Male 60-day-old CFW mice (23-28 g) Dosage: 0.3 μg/kg, 1.0 μg/kg, 3.0 μg/kg, 10 μg/kg Administration: Intraperitoneal injection; post-training Result: Significantly enhanced retention of both inhibitory avoidance and Y-maze discrimination tasks in a dose-dependent manner. |
dipivefrinehydrochloride - Risk and Safety
| UN IDs | UN 2811 6.1 / PGIII |
| HS Code | 2922504500 |
dipivefrinehydrochloride - Standard
Authoritative Data Verified Data
This product is (±) 3,4-dihydroxy-a -[ (methylamino) methyl] benzyl alcohol -3, 4-dipivalate hydrochloride. The content of C19H29N05 • HC1 shall be between 98.5% and 101.5% calculated as dry.
Last Update：2024-01-02 23:10:35
dipivefrinehydrochloride - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Odorless; Hygroscopic; Easy to deteriorate in contact with sunlight or air.
- This product is very soluble in water, soluble in ethanol, very slightly soluble in ethyl acetate, almost insoluble in petroleum ether.
melting point
The melting point of this product (General rule 0612) is 161~166°C, and the melting distance is within 2°C.
Last Update：2022-01-01 14:22:28
dipivefrinehydrochloride - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, add 10ml of sodium hydroxide solution to dissolve, the solution is slowly light yellow, the solution is observed under UV light (365nm), yellow fluorescence.
- 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 335).
- This product is chloride identification reaction (General 0301).
Last Update：2022-01-01 14:22:28
dipivefrinehydrochloride - Exam
Authoritative Data Verified Data
acidity
take 0.10g of this product, Add 10ml of water to dissolve it, and determine it according to law (General rule 0631). The pH value should be 5.0~6.5.
clarity and color of solution
take this product and add water to make a solution containing lOOmg per lml, which should be clear and colorless.
Related substances
take this product, precision weighing, adding mobile phase dissolution and quantitative dilution to make a solution containing about 1 mg per 1 ml, as a test solution; Take appropriate amount of precision, A solution containing 10ug per 1 ml was prepared by quantitative dilution with mobile phase and used as a control solution; (± ) 3, 4-dihydroxy-2-methylaminoacetophenone-3 was additionally taken, 4-dipivalate perchlorate (impurity I) control appropriate amount, precision weighing, plus mobile phase to dissolve and quantitative dilution to prepare a solution containing about 5ug per 1 ml, as a control 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 2 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the chromatographic peak area with the same retention time as the main peak of the reference solution shall not be greater than the main peak area of the reference solution (0.5%); the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
loss on drying
take this product and dry under reduced pressure at 60°C for 6 hours, and the weight loss shall not exceed 1.0% (General rule 0831).
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.3%.
Heavy metals
The residue left under the ignition residue item shall not contain more than 15 parts per million of heavy metals as inspected by law (General rule 0821, Law II).
Last Update：2022-01-01 14:22:29
dipivefrinehydrochloride - 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 as filler; Phosphate buffer solution (13.6g of potassium dihydrogen phosphate, dissolved in water and diluted to 1000ml, adjusted to pH 10% with 3.5 phosphoric acid solution)-Acetonitrile (60:40) as mobile phase; The detection wavelength was 254nm. The number of theoretical plates shall not be less than 1500 calculated according to the peak of dipifu forest, and the separation degree between dipifulin peak and adjacent impurity peaks shall meet the requirements.
assay
take an appropriate amount of this product, accurately weigh it, add mobile phase to dissolve and quantitatively dilute to make a solution containing about 1 mg per 1 ml, as a test solution, and inject 20u1 into the liquid chromatograph with precise amount, the chromatogram was recorded; The reference substance of depilin hydrochloride was taken and determined by the same method. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 14:22:30
dipivefrinehydrochloride - Category
Authoritative Data Verified Data
ophthalmic medication.
Last Update：2022-01-01 14:22:30
dipivefrinehydrochloride - Storage
Authoritative Data Verified Data
light-shielded, sealed, and stored in a dry place.
Last Update：2022-01-01 14:22:30
dipivefrinehydrochloride - Depilin hydrochloride eye drops
Authoritative Data Verified Data
This product contains depilin hydrochloride (C19H29N05 • HCI) should be 90.0% ~ 110.0% of the label amount.
trait
This product is colorless and clear liquid.
identification
- take about 5ml of this product, add 2ml of sodium hydroxide solution, and place it for several minutes. The solution shows light yellow color.
- 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 3.5 to 5.0 (General 0631).
- Related substances the product was taken as a test solution and determined by the method under the item of related substances of depilin hydrochloride. If there are impurity peaks in the chromatogram of the test solution, the chromatographic peak area with the same retention time as the main peak of the reference solution shall not be greater than the main peak area of the reference solution (0.5%), the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- others shall comply with the relevant provisions under Ophthalmic Preparations (General rule 0105).
Content determination
take this product, as a test solution, according to the method under the item of determination of the content of hydrochloric acid depilin, obtained.
category
same with depilin hydrochloride.
specification
(l)5ml:5mg (2)8ml:8mg
storage
shade, seal, and store in a cool place.
Last Update：2022-01-01 14:22:31
