58-33-3 - Names and Identifiers
58-33-3 - Physico-chemical Properties
Molecular Formula | C17H21ClN2S
|
Molar Mass | 320.88 |
Melting Point | 230-232°C |
Boling Point | 403.7 °C at 760 mmHg |
Flash Point | 9℃ |
Solubility | Easily soluble in water, soluble in ethanol or chloroform, almost insoluble in acetone or ether |
Appearance | White or off-white powder |
Color | White to Almost white |
Maximum wavelength(λmax) | ['297nm(H2O)(lit.)'] |
Merck | 14,7786 |
BRN | 4166397 |
PH | pH (50g/L, 25℃) : 4.0~6.0 |
Storage Condition | 2-8°C |
Sensitive | Sensitive to light |
MDL | MFCD00012652 |
Use | Applicable to various allergic diseases and pregnancy Vomit |
58-33-3 - Risk and Safety
Risk Codes | R22 - Harmful if swallowed
R36/37/38 - Irritating to eyes, respiratory system and skin.
R51/53 - Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
R43 - May cause sensitization by skin contact
R20/22 - Harmful by inhalation and if swallowed.
|
Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S36 - Wear suitable protective clothing.
S61 - Avoid release to the environment. Refer to special instructions / safety data sheets.
S60 - This material and its container must be disposed of as hazardous waste.
S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection.
S28 - After contact with skin, wash immediately with plenty of soap-suds.
S22 - Do not breathe dust.
|
UN IDs | UN 2811 6.1/PG 3 |
WGK Germany | 3 |
RTECS | SO8225000 |
HS Code | 29343000 |
Hazard Class | 6.1(b) |
Packing Group | III |
Toxicity | LD50 i.v. in mice: 55.0 mg/kg (Rajsner) |
58-33-3 - Reference
Reference Show more | 1. [IF=3.935] Yixuan 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 |
58-33-3 - Standard
Authoritative Data Verified Data
This product is (±)-N,N,a-trimethyl-10h-phenothiazine-10-ethylamine hydrochloride. The content of C17H20N2S • HCl shall not be less than 99.0% calculated on a dry basis.
Last Update:2024-01-02 23:10:35
58-33-3 - Trait
Authoritative Data Verified Data
- This product is white or white-like powder or granules; Almost odorless; In the air, the day long deterioration, blue.
- This product is easily soluble in water, soluble in ethanol or dichloromethane, and almost insoluble in propyl copper or ether.
absorption coefficient
take this product, precision weighing, plus O.Olmol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 6ug per lml, and the absorbance was measured at the wavelength of 249mn by UV-Vis spectrophotometry (General rule 0401), the absorption coefficient is 883 to 937.
Last Update:2022-01-01 15:04:29
58-33-3 - Differential diagnosis
Authoritative Data Verified Data
- take about 5mg of this product, add sulfuric acid 5ml to dissolve, the solution shows cherry red; After placement, the color gradient is deep.
- take about 0.1g of this product, add 3ml of water to dissolve, and then add 1ml of nitric acid to generate red precipitate; Heat, precipitate will dissolve, and the solution will change from red to orange.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 350).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update:2022-01-01 15:04:29
58-33-3 - Exam
Authoritative Data Verified Data
acidity
take 0.50g of this product, Add 10ml of water to dissolve, and measure according to law (General rule 0631). The pH value should be 4.0~5.0.
clarity and color of solution
take l.Og of this product, add 10ml of water to dissolve, the solution should be clear and colorless. If it is turbid, it should not be more concentrated compared with No. 1 turbidity standard solution (General rule 0902 first method); If it is colored, it should not be deeper compared with yellow No. 2 Standard Colorimetric solution (General rule 0901 first method).
Related substances
operation in the dark. Take this product, plus O. 1 mol/L hydrochloric acid solution is dissolved and diluted to make a solution containing about 0.2mg per 1 ml as a test solution; Take 1 ml for precision measurement, put it in a 100ml measuring flask, and use 0.1 mol/L hydrochloric acid solution was diluted to the scale and shaken to serve as a control solution. According to the high performance liquid chromatography (General 0512) test, with eighteen alkyl silane bonded silica gel as filler, water (with glacial acetic acid to adjust the pH value to 2.3)-methanol (55:45) as mobile phase, the detection wavelength was 254nm. The theoretical plate number is not less than 3000 according to the calculation of the promethazine hydrochloride peak, and the separation degree of the promethazine hydrochloride peak from the impurity peak with the relative retention time of 1.1 to 1.2 should 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 the main component chromatographic 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 (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 15:04:32
58-33-3 - Content determination
Authoritative Data Verified Data
take this product about 0.25g, precision weighing, add 0.01mol/L hydrochloric acid solution 5ml and ethanol 50ml to dissolve. Potentiometric titration (General 0701), with sodium hydroxide titration solution (0.lmol/L) titration, record the number of consumed milliliters V1 when the first burst occurs, continue titration until the number of consumed milliliters V2 when the second burst occurs, the difference between V and V1 is the volume of the consumed titration solution. Each 1 ml of sodium hydroxide titration solution (0.1 mol/L) corresponds to 32.09mg of C17H20N2S • HCl.
Last Update:2022-01-01 15:04:31
58-33-3 - Category
Authoritative Data Verified Data
Last Update:2022-01-01 15:04:31
58-33-3 - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update:2022-01-01 15:04:31
58-33-3 - Promethazine Hydrochloride Tablets
Authoritative Data Verified Data
This product contains promethazine hydrochloride (C17H20N2S • HCl) should be 93.0% ~ 107.0% of the label amount.
trait
This product is sugar-coated tablets, white to yellowish after removing the coating.
identification
- take this product, remove the coating, grind, weigh an appropriate amount (equivalent to 0.2g of promethazine hydrochloride), add 10ml of water, shake to dissolve promethazine hydrochloride, filter, the filtrate was evaporated to dryness on a water bath, and the residue showed the same reaction according to the tests of identification tests (1), (2) and (4) in the case of promethazine hydrochloride.
- take 5 tablets (50mg specification), 10 tablets (25mg specification) or 20 tablets (12.5mg specification) of this product, remove the coating, and place the mortar to grind it, add an appropriate amount of methanol-diethylamine (95:5) to dissolve promethazine hydrochloride and transfer to a 25ml measuring flask, dilute to the mark with the above solvent, shake and filter, the filtrate was taken as a test solution, and the promethazine hydrochloride control was additionally taken, dissolved and diluted with the above solvent to prepare a solution containing 10 mg per 1 ml as a control solution. 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 ethane-acetone-diethylamine (8.5:1: 0.5) for the development of the agent, expand, dry, set the UV light (254nm) under the inspection. The position and color of the main spot displayed by the test solution should be the same as that of the reference solution.
- 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.
- take an appropriate amount of fine powder of this product (about equivalent to isopropyl chloride lOOmg), add 10ml of chloroform, grind and dissolve, filter, evaporate the filtrate in water bath, dry the residue under reduced pressure, and determine it according to law (General rule 0402). The infrared absorption spectrum of this product should be consistent with the spectrum of the control (Spectrum set 3 5 0 figure).
- two items (2) and (3) above can be selected as one item.
examination
- the related substances were protected from light. Take the filtrate under the content determination item as the test solution; Take 1ml of precision measurement, put it in a 100ml measuring flask, and use 0.1 mol/L hydrochloric acid solution was diluted to the scale and shaken to serve as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution and the control solution are accurately measured, and the human liquid chromatograph is injected respectively, 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 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%).
- dissolution dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), hydrochloric acid solution (9-100) as the dissolution medium, the speed is rpm, operate in accordance with the law, after 45 minutes, take 10ml of solution, filter, take the appropriate amount of the precise amount of filtrate, and dilute it quantitatively with water to make a solution containing 5ug of promethazine hydrochloride per lml, the absorbance was measured at a wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (General rule 910), and the elution amount of each tablet was calculated as the absorption coefficient of C17H20N2S · HCl was. The limit is 80% 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
- light-shielding operation. Determined by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Water (with glacial acetic acid to adjust the pH value to 2.3)-methanol (55:45) as mobile phase; the detection wavelength was 254mn. The theoretical plate number is not less than 3000 according to the calculation of the promethazine hydrochloride peak, and the separation degree of the promethazine hydrochloride peak from the impurity peak with the relative retention time of 1.1 to 1.2 should be greater than 2.0.
- determination of 10 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (equivalent to 20mg promethazine hydrochloride), put in a 100ml measuring flask, add 0.lmol/L hydrochloric acid solution appropriate amount, shaking to dissolve promethazine hydrochloride and 0. Dilute 1 mol/L hydrochloric acid solution to the scale, shake well, filter, Take 5ml of filtrate accurately, put it in a 50ml measuring flask, dilute it to the scale with water, shake well, and use it as a test solution, accurately take 20u1 injection liquid chromatograph, record chromatogram; Another promethazine hydrochloride reference, precision weighing, add 0.1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 0.02mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
with promethazine hydrochloride.
specification
(1)12.5mg (2)25mg (3)50mg
storage
light shielding, sealed storage.
Last Update:2022-01-01 15:04:33
58-33-3 - Promethazine Hydrochloride Injection
Authoritative Data Verified Data
- This product is a sterilized aqueous solution of promethazine hydrochloride. The content of promethazine hydrochloride (C17H20N2S • HCl) shall be between 95.0% and 105.0% of the labeled amount.
- This product can be added with an appropriate amount of vitamin C.
trait
This product is a clear colorless liquid.
identification
- 0.2ml of this product was taken and evaporated to dryness, and the residue showed the same reaction according to the test of identification items (1), (2) and (4) of promethazine hydrochloride.
- take 10ml of this product, put it in a 25ml measuring flask, add methanol-diethylamine (95:5) to dissolve and dilute to the scale, shake, as a test solution; another promethazine hydrochloride control was dissolved and diluted with methanol-diethylamine (95:5) to prepare a solution containing about 10 mg per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions of each L01, respectively, on the same silica gel GF254 thin layer plate, with hexane-acetone-diethylamine (8.5:1:0.5) for the development of the solvent, expand, dry, set the UV light (254nm) under the view. The position and color of the main spot displayed by the test solution should be the same as that of the reference solution.
- 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.
- two items (2) and (3) above can be selected as one item.
examination
- the pH value should be 4.0 to 5.5 (General 0631).
- the related substances were protected from light. Take the stock solution of the test product under the item of content determination as the test solution; Take 1ml with precision, put it in a 100ml measuring flask, and use 0.1 mol/L hydrochloric acid solution was diluted to the scale and shaken to serve as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of each of the test solution and the control solution are accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram is recorded to 3 times of the retention time of the main component peak. Take an appropriate amount of vitamin C, add 0.lmol/L hydrochloric acid solution to dissolve and dilute to make a solution containing 0.02mg per lml. Take 20u1 and inject human chromatograph to record the chromatogram. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area except the vitamin C peak shall not be greater than the main peak area of the control solution (1.0%).
- bacterial endotoxin take this product, according to the law inspection (General 1143), each 1 mg promethazine hydrochloride containing endotoxin amount should be less than 3.0 EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- light-shielding operation. Determined by high performance liquid chromatography (General 0512).
- chromatographic conditions and system applicability test using eighteen alkyl silane bonded silica gel as filler; Water (with glacial acetic acid to adjust the p H value to 2.3)-methanol (55:45) as mobile phase; the detection wavelength was 254nm. The theoretical plate number is not less than 3000 according to the calculation of the promethazine hydrochloride peak, and the separation degree of the promethazine hydrochloride peak from the impurity peak with the relative retention time of 1.1 to 1.2 should be greater than 2.0.
- determination of precision take an appropriate amount of this product (about 50mg equivalent to promethazine hydrochloride), put it in a 250ml volumetric flask, and use 0. Dilute 1 mol/L hydrochloric acid solution to the scale, shake well, as a sample stock solution, Take 5ml, put it in a 50ml measuring flask, dilute it to the scale with water, shake well, as the test solution, the sample was accurately measured by 20u1 injection liquid chromatograph, and the chromatogram was recorded. 1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 0.02mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
with promethazine hydrochloride.
specification
(l)lml:25mg (2)2ml:50mg
storage
light shielding, closed storage.
Last Update:2022-01-01 15:04:34