147-24-0
Diphenhydramine hydrochloride
CAS: 147-24-0;8052-21-9
Molecular Formula: C17H22ClNO
147-24-0 - Names and Identifiers
| Name | Diphenhydramine hydrochloride |
| Synonyms | Dimedrolum Benzhydramine Diphenhydramine HCl Benzhydramine hydrochloride Diphenhydramine hydrochloride Diphenhydramine hydrochlorids 2-(diphenylmethoxy)-N,N-dimethylethanamine N-(2-Diphenylmethoxyethyl)-N,N-dimethylamine hydrochloride |
| CAS | 147-24-0 8052-21-9 |
| EINECS | 205-687-2 |
| InChI | InChI=1/C17H21NO.2ClH/c1-18(2)13-14-19-17(15-9-5-3-6-10-15)16-11-7-4-8-12-16;;/h3-12,17H,13-14H2,1-2H3;2*1H |
147-24-0 - Physico-chemical Properties
| Molecular Formula | C17H22ClNO |
| Molar Mass | 291.81568 |
| Melting Point | 168-172℃ |
| Boling Point | 343.7°C at 760 mmHg |
| Water Solubility | 1000 g/L |
| Solubility | DMSO 58 mg/mL;Water 58 mg/mL;Ethanol 58 mg/mL. It is easily soluble in water, easily soluble in ethanol or chloroform, slightly soluble in acetone, and very slightly soluble in ether or benzene. |
| Appearance | White crystalline powder |
| Storage Condition | 2-8℃ |
| MDL | MFCD00012479 |
147-24-0 - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R22 - Harmful if swallowed |
147-24-0 - Reference
| Reference Show more | 1. Chen Minyang Limeiluo Dongmei et al. Determination of dabigatran concentration in human plasma by HPLC-MS/MS [J]. Fujian Journal of Medicine 2018 40(006):118-123. 2. Silver content, Liu Ha Xiaoyu, Liu Yutong, et al. Study on therapeutic effect and molecular mechanism of Qingpeng Ointment on pruritus model mice [J], 2019(6). 3. Gong Xuan, Liu Sisi, Silver Volume, et al. Therapeutic Effect of Qingpeng Ointment on Histamine-induced Acute Pruritus Model Mice [J]. Medical Guide, 2018, 037(010):1166-1169. 4. Wan Jiayang, Tian Yanfang, Wan Haitong, etc. pharmacokinetic study of effective components of ephedra decoction in febrile rats [J]. Chinese journal of traditional Chinese medicine, 2019(10). 5. yin yanchao, su aoxuan, Cui yixuan, feng jingying, Jiang ye. Determination of Diphenhydramine in Human Saliva by Dispersion-Liquid Microextraction Combined with Ion Mobility Spectroscopy [J]. Analysis Laboratory, 2021,40(01):59-63. 6. Gao Qizhen, Liu Fangyu, Ding Pingtian. A method for the determination of tamsulosin hydrochloride sustained-release tablets in Beagle dogs was established based on liquid chromatography-mass spectrometry [J]. Shandong Science, 2021,34(02):34-41. 7. Yixuan Cui, Di Liu, Mengqiang Zhao, Junmei Li, Yuke Yang, Mengjiao Li, Jinglin Gao, Ye Jiang, A fast and simple approach for the quantification of five anti-hypersensitivity drugs in saliva and urine by portable ion mobility spectrometry based on magnetic 8. [IF = 3.935] Pengcheng Huang et al."Correlation study between the pharmacokinetics of seven main active ingredients of Mahuang decoction and its pharmacodynamics in asthmatic rats." J Pharmaceut Biomed. 2020 May;183:113144 9. [IF = 3.935] Yiyuan Cui et al."A fast and simple approach for the quantification of five anti-hypersensitivity drugs in saliva and urine by portable ion mobility spectrometry based on magnetic graphene oxide dispersive solid phase extraction." J Pharmaceut Biomed. 2020 10. [IF = 3.845] Gong Xuan et al."Qingpeng Ointment Ameliorates Inflammatory Responses and Dysregulation itch-Related Molecules for Its Antipruritic Effects in Experimental Allergic Contact Dermatitis." Front Pharmacol. 2019 Apr;0:354 11. [IF = 3] wan haoyu et al."Pharmacokinetics of seven major active components of Mahuang decoction in rat blood and brain by LC-MS/MS coupled to microdialysis sampling." N-S Arch Pharmacol. 2020 Aug;393(8):1559-1571 12. [IF = 1.312] Xiaoyun Duan et al."A micellar HPLC method for simultaneous determination of six active ingredients in cold compound preparations." Journal Of Liquid Chromatography & Related Technologies. 2019 Jun 24 |
147-24-0 - Standard
Authoritative Data Verified Data
This product is N, n-dimethyl-2-(diphenylmethoxy) ethylamine hydrochloride. The content of C17H21N0 • HCl shall be between 98.0% and 102.0% calculated on the dried product.
Last Update：2024-01-02 23:10:35
147-24-0 - Trait
Authoritative Data Verified Data
- This product is white crystalline powder; Odorless.
- This product is easily soluble in water, soluble in ethanol or three gas methane, slightly soluble in acetone, and slightly soluble in ether.
melting point
The melting point of this product (General 0612) is 167~171°C.
Last Update：2022-01-01 15:05:43
147-24-0 - Differential diagnosis
Authoritative Data Verified Data
- take about 5mg of this product and add 1 drop of sulfuric acid, which is yellow at the beginning and then turns into orange red.
- take this product, add O.Olmol/L hydrochloric acid solution is dissolved and diluted to prepare a solution containing about 0401 mg per 1 ml, which is determined by UV-Vis spectrophotometry (general rule), there is a maximum absorption at the wavelength of 253nm and 258nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 365).
- the aqueous solution of this product can identify the reaction of (1) (General rule 0301).
Last Update：2022-01-01 15:05:44
147-24-0 - Exam
Authoritative Data Verified Data
clarity and color of solution
take this product l. After being dissolved by adding 20ml of fresh boiling cold water, the solution shall be clear and colorless; In case of color development, it shall not be deeper in comparison with yellow No. 1 Standard Colorimetric solution (General rule 0901 method 1).
Related substances
take this product, add mobile phase to dissolve and dilute to make a solution containing about 2.5mg per lml as a test solution; Take lml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of the control solution and the test solution are respectively injected into the liquid chromatograph, 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%) the area of the main peak of the control solution, and the sum of the areas of each impurity peak shall not be greater than the area of the main peak of the control solution (1.0%).
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 15:05:45
147-24-0 - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
A cyano-bonded silica gel was used as a filler; Acetonitrile-water-triethylamine (50:50:0.5)(pH adjusted to 6.5 with glacial acetic acid) was used as a mobile phase; The detection wavelength was 258nm. Take benzophenone 5mg in a 100ml measuring flask, add acetonitrile 5ml to dissolve, dilute with water to the mark, shake well; Take diphenhydramine hydrochloride 5mg in a 10ml measuring flask, add the above benzophenone solution 1ml, dilute to scale with water, shake well, inject 20ul into liquid chromatograph, record chromatogram. The number of theoretical plates shall not be less than 5000 calculated by the peak of diphenhydramine, and the separation degree of diphenhydramine peak and benzophenone peak shall be greater than 2.0.
assay
take this product, precision weighing, adding water to dissolve and quantitatively dilute to make a solution containing about 0.5mg per lml, take 20u1 injection of human liquid chromatography with precision, record chromatogram; Take diphenhydramine hydrochloride reference substance, same method determination. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 15:05:46
147-24-0 - Category
Authoritative Data Verified Data
antihistamines.
Last Update：2022-01-01 15:05:46
147-24-0 - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 15:05:46
147-24-0 - Diphenhydramine Hydrochloride Tablets
Authoritative Data Verified Data
This product contains diphenhydramine hydrochloride (C17H21NO • HCl) should be 93.0% ~ 107.0% of the label amount.
trait
This product is sugar-coated tablet or film-coated tablet, White after removing the coating.
identification
- take this product, remove the coating, grind, take an appropriate amount (approximately equivalent to diphenhydramine hydrochloride O.lg), with chloroform 10ml shaking extraction, filtering; Filtrate is dried on water bath, residue after drying at 80°C, according to the identification of diphenhydramine hydrochloride (1), (4) one trial showed the same response.
- 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 the fine powder of this product (about 25mg of diphenhydramine hydrochloride), put it in a 10ml measuring flask, add an appropriate amount of mobile phase, shake to dissolve diphenhydramine hydrochloride, dilute it to the scale with the mobile phase, and shake it well, filter, take the filtrate as a test solution; Take 1ml of precision, 100ml flask, diluted with mobile phase to the scale, shake, as a control solution. According to the related substances of diphenhydramine hydrochloride determination method. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0% ) , and the sum of each impurity peak area shall not be greater than 2 times the area of the main peak of the control solution (2.0%)
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), with water as the dissolution medium, the speed is 100 rpm, according to the law, after 45 minutes, 5ml of the solution was taken, filtered, and the filtrate was taken as the test solution, water was added to dissolve and quantitatively diluted to prepare a solution containing about 50ug per 1 ml as a control solution. According to the chromatographic conditions under the content determination item, 50 u1 of the test solution and 50 u1 of the reference solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded. The dissolution amount of each tablet was calculated by the peak area according to the external standard method. The limit is 70% 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, after removing the coating, weigh them precisely, grind them finely, weigh an appropriate amount (about 50mg of diphenhydramine hydrochloride), and put them in a 100ml measuring flask, the diphenhydramine hydrochloride was dissolved and diluted to the scale by shaking with an appropriate amount of water, then shaken well, filtered, and the filtrate was taken as a test solution, which was obtained by measuring the content of diphenhydramine hydrochloride according to the method under the item of determining the content of diphenhydramine hydrochloride.
category
with diphenhydramine hydrochloride.
specification
25mg
storage
sealed storage.
Last Update：2022-01-01 15:05:47
147-24-0 - Diphenhydramine Hydrochloride Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of diphenhydramine hydrochloride. The content of diphenhydramine hydrochloride (C17H21N0 • HC1) shall be between 95.0% and 105.0% of the labeled amount.
trait
This product is a clear colorless liquid.
identification
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 control solution.
examination
- the pH value should be 4.0 to 6.0 (General 0631).
- Related substances take this product, dilute it with mobile phase to make a solution containing 2.5mg diphenhydramine hydrochloride per 1 ml, shake well, and use it as a test solution. Take 1 ml with precision and put it in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to the related substances of diphenhydramine hydrochloride determination method. 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%) the area of the main peak of the control solution, and the sum of the areas of each impurity peak shall not be greater than the area of the main peak of the control solution (1.0%).
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take an appropriate amount of this product (about 50mg equivalent to diphenhydramine hydrochloride), put it in a 100ml measuring flask, dilute it with water to the scale, shake it well, and use it as a test solution, according to the determination of diphenhydramine hydrochloride content under the item of the method for the determination, that is obtained.
category
with diphenhydramine hydrochloride.
specification
lml:20mg
storage
light shielding, closed storage.
Last Update：2022-01-01 15:05:48
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