Cetirizine hydrochloride
Cetirizine DI HCL
CAS: 83881-52-1
Molecular Formula: C21H26Cl2N2O3
Cetirizine hydrochloride - Names and Identifiers
| Name | Cetirizine DI HCL |
| Synonyms | Cesta Alerid Cetrak Cetiriz Alercet Cetirizine Hcl Cetrizine Di-HCl Cetirizine DI HCL Cetirizine Hydrochloride Cetrizine dihydrochloride Cetirizine Hydrochloride (250 mg) (2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)aceticaciddihydro 2-(2-{4-[(4-Chlorophenyl)(phenyl)-methyl]piperazino}ethoxy)acetic acid dihydrochloride (2-{4-[(4-chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)acetic acid dihydrochloride 2-[2-[4-[(4-chlorophenyl)-phenyl-methyl]piperazin-1-yl]ethoxy]acetic acid dihydrochloride |
| CAS | 83881-52-1 |
| EINECS | 620-533-8 |
| InChI | InChI=1/C21H25ClN2O3.2ClH/c22-19-8-6-18(7-9-19)21(17-4-2-1-3-5-17)24-12-10-23(11-13-24)14-15-27-16-20(25)26;;/h1-9,21H,10-16H2,(H,25,26);2*1H |
| InChIKey | PGLIUCLTXOYQMV-UHFFFAOYSA-N |
Cetirizine hydrochloride - Physico-chemical Properties
| Molecular Formula | C21H26Cl2N2O3 |
| Molar Mass | 425.35 |
| Melting Point | 110-115°C |
| Boling Point | 542.1°C at 760 mmHg |
| Flash Point | 281.6°C |
| Water Solubility | Soluble in water, DMSO, ethanol, and methanol. |
| Solubility | Soluble in water (100 mM),DMSO (100 mM), ethanol (10 mM) and methanol |
| Vapor Presure | 1.39E-12mmHg at 25°C |
| Appearance | White or white-like powder |
| Color | white to beige |
| Merck | 14,2022 |
| Storage Condition | 2-8°C |
| Stability | Hygroscopic |
| MDL | MFCD00941428 |
| Use | Mainly used for allergic diseases of the respiratory system, skin and eyes |
Cetirizine hydrochloride - Risk and Safety
| Risk Codes | R22 - Harmful if swallowed R36/37/38 - Irritating to eyes, respiratory system and skin. |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36 - Wear suitable protective clothing. |
| UN IDs | 3249 |
| WGK Germany | 3 |
| RTECS | AG0977500 |
| HS Code | 29339900 |
| Hazard Class | 6.1(b) |
| Packing Group | III |
Cetirizine hydrochloride - Reference
| Reference Show more | 1. [IF=4.098] Yixuan Cui et al."Development of silica molecularly imprinted polymer on carbon dots as a fluorescence probe for selective and sensitive determination of cetirizine in saliva and urine."Spectrochim Acta A. 2022 Jan;264:120293 |
Cetirizine hydrochloride - Standard
Authoritative Data Verified Data
This product is (±)-2 -[2 -[4 -[(4-chlorophenyl) benzyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Calculated as dry product, containing C21H25CIN203 • 2HC1 shall not be less than 99.0%.
Last Update：2024-01-02 23:10:35
Cetirizine hydrochloride - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder, odorless.
- This product is soluble in water, soluble in methanol or ethanol, almost insoluble in chloroform or acetone.
absorption coefficient
take this product about 20mg, precision weighing, 100ml flask, add 0.1 mol/L hydrochloric acid solution to dissolve and dilute to the scale, shake; Precision take 5ml, 100ml flask, with 0.1 mol/L hydrochloric acid solution is diluted to the scale, shake well, according to ultraviolet-visible spectrophotometry (General rule 0401), absorbance is measured at the wavelength of 231nm, absorption coefficient) is 365~385.
Last Update：2022-01-01 14:22:40
Cetirizine hydrochloride - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, add an appropriate amount of methanol, shake to dissolve, dilute to 100ml with methanol, shake well, as a test solution; Take an appropriate amount of Cetirizine Hydrochloride control, methanol was added to dissolve and diluted to make each 1 ml containing 0.1 mg solution, as a control solution. According to the thin layer chromatography (General 0502) test, draw 10 u1 of the test solution and the reference solution, respectively, and put them on the same silica gel G thin layer plate, with dichloromethane-methanol-concentrated ammonia solution (4:1:0.2) as the developing solvent, spread out, dry, set the iodine vapor in the color, immediately check, the color and position of the main spot displayed by the test solution should be consistent with the main spot of the control solution.
- take this product, add 0.lmol/L hydrochloric acid solution is dissolved and diluted to prepare a solution containing 10ug per lml, which is determined by ultraviolet-visible spectrophotometry (General 0401) and has a maximum absorption at the wavelength of 231nm, there is minimal absorption at a wavelength of 218nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 826).
- the aqueous solution of this product should show the reaction of chloride identification (1) (General rule 0301).
Last Update：2022-01-01 14:22:40
Cetirizine hydrochloride - Exam
Authoritative Data Verified Data
acidity
take about 0.5g of this product, Add 10ml of water to dissolve it, and measure it according to law (General rule 0631). The pH value should be 1.2~1.8.
clarity and color of solution
take 1.0g of this product, add 0901 of water to dissolve, the solution should be clear and colorless; If the color is colored, it should not be deeper than the yellow-green No. 1 Standard Colorimetric liquid (General rule first method).
cyanide
take this product 1.0g, inspection according to law (General Principles 0806 The first law), should comply with the provisions.
Related substances
take an appropriate amount of this product, add water to dissolve and dilute to make a solution containing 0.2mg per lml as a test solution; Take an appropriate amount for precision measurement, water was added to dilute to prepare a solution containing 2% per 1 ml as a control solution; An appropriate amount of the control solution was accurately measured and diluted with water to prepare a solution containing 0.2ug per 1 ml as a sensitivity solution. According to the high performance liquid chromatography (General 0512) test, using eighteen alkyl silane bonded silica gel as filler, acetonitrile-0.1% triethylamine 0.05mol/L sodium dihydrogen phosphate solution (with phosphoric acid to adjust the pH value to 3.0)(35:65) as the mobile phase, the detection wavelength was 230nm, the number of theoretical plate according to cetirizine peak is not less than 4000. The sensitivity of 20ul solution into the liquid chromatograph, the main peak signal to noise ratio should not be less than 10. 20ul 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 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%) of the area of the main peak of the control 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
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy metals
The residue left under the item of ignition residue shall be inspected according to law (General rule 0821 second law), and the content of heavy metal shall not exceed 10 parts per million.
Last Update：2022-01-01 14:22:41
Cetirizine hydrochloride - Content determination
Authoritative Data Verified Data
take this product about 0.18g, precision weighing, add glacial acetic acid 20ml dissolved, add mercury acetate test solution 5ml and 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 perchloric acid titration solution (0.1 mol/L) corresponds to 23.09mg of c21h25c1n203.2hcl.
Last Update：2022-01-01 14:22:42
Cetirizine hydrochloride - Category
Authoritative Data Verified Data
histamine receptor antagonist.
Last Update：2022-01-01 14:22:42
Cetirizine hydrochloride - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 14:22:43
Cetirizine hydrochloride - Cetirizine Hydrochloride oral solution
Authoritative Data Verified Data
This product contains Cetirizine Hydrochloride (C21H25C1N203 • 2HC1) should be 90.0% ~ 110.0% of the label amount.
trait
This product is a colorless clear 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 reference solution.
- This product chloride identification (1) of the reaction (General 0301).
examination
- the pH value should be 3.8 to 5.8 (General 0631).
- others should comply with the relevant provisions under the item of oral solution (General rule 0123).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica as filler, with 0.1 mol/ L potassium dihydrogen phosphate solution (adjusted to pH 3.7 with phosphoric acid)-acetonitrile (60:40) as mobile phase, the detection wavelength was 232nm, and the number of theoretical plates was not less than 2000 based on the cetirizine peak.
- determination precision: take an appropriate amount of this product and quantitatively dilute it with water to prepare a solution containing 50ug of Cetirizine Hydrochloride per 1 ml as a test solution; in addition, an appropriate amount of the reference substance of Cetirizine Hydrochloride was accurately weighed, dissolved with water and quantitatively diluted to prepare a solution containing 50ug per 1 ml, which was used as a reference solution. 20 u1 of the test solution and the reference solution were respectively injected into the liquid chromatograph, and the chromatograms were recorded. According to the external standard method to calculate the peak area, that is.
category
with Cetirizine Hydrochloride.
specification
10ml:1Omg
storage
shade, seal, and store in a cool place.
Last Update：2022-01-01 14:22:43
Cetirizine hydrochloride - Cetirizine Dihydrochloride Tablets
Authoritative Data Verified Data
This product contains Cetirizine Hydrochloride (C21H25C1N203 • 2HC1) should be 90.0% ~ 110.0% of the label amount.
trait
This product is white or white-like tablets or film-coated tablets, film-coated tablets after removal of coating, white or white.
identification
- take an appropriate amount of fine powder of this product (about 40mg equivalent to Cetirizine Hydrochloride), put it in a 100ml measuring flask, add water to dissolve Cetirizine Hydrochloride and dilute it to the scale, shake well, filter; precisely take 2ml of continued filtrate, put it in a 50ml measuring flask, dilute it to the scale with water, shake it well, and measure it according to UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at a wavelength of 231nm and a minimum absorption at a wavelength of 218nm.
- 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 aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
examination
- 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 30 minutes, 10ml 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 10ug per 1 ml as a control solution. The above two kinds of solutions were taken separately, and the absorbance was measured at a wavelength of 0401 nm by ultraviolet-visible spectrophotometry (general) to calculate the dissolution amount of each tablet. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- Content uniformity take 1 tablet of this product, put it in a 100ml measuring flask, add appropriate amount of water, fully shake to dissolve Cetirizine Hydrochloride, dilute it to the scale with water, shake well, filter, take 10ml of continuous filtrate accurately, put it in a 100ml measuring flask, dilute it to scale with water, shake it well, and use it as a test solution. Take an appropriate amount of Cetirizine Hydrochloride reference, and weigh it accurately, water was added to dissolve and quantitatively diluted to prepare a solution containing about lOug per 1 ml as a control solution. Take the above two kinds of solution, respectively, according to UV-visible spectrophotometry (General rule 0401) at the wavelength of 230nm absorbance determination, calculate the content, should comply with the provisions (General rule 0941).
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica as filler; 0.1 mol / L sodium dihydrogen phosphate solution (adjusted to pH 3.7 with phosphoric acid)-acetonitrile (60:40) as mobile phase; The detection wavelength was 232nm. The theoretical plate number is not less than 2000 based on the cetirizine peak.
- determination Method: Take 20 tablets of this product (film-coated tablets are removed from the coating), precisely weigh them, grind them finely, and precisely weigh an appropriate amount of fine powder (equivalent to 10 mg of Cetirizine Hydrochloride), put them in a 100ml measuring flask, add appropriate amount of water, sonicate to dissolve Cetirizine Hydrochloride and dilute to the scale, shake well, filter, discard the initial filtrate, and take the continued filtrate as the test solution, water was added to dissolve and quantitatively diluted to prepare 0.1 mg solution, as a control solution. 20ul of the test solution and the reference solution were respectively injected into the human liquid chromatograph, and the chromatograms were recorded. According to the external standard method to calculate the peak area, that is.
category
with Cetirizine Hydrochloride.
specification
1Omg
storage
shade, Seal, store in a dry place
Last Update：2022-01-01 14:22:44
Cetirizine hydrochloride - Cetirizine Hydrochloride capsules
Authoritative Data Verified Data
This product contains Cetirizine Hydrochloride (C21H25C1N203 • 2HC1) should be 90.0% ~ 110.0% of the label amount.
trait
The content of this product is white or white particles or powder.
identification
- take an appropriate amount of the content of this product (about 40mg equivalent to Cetirizine Hydrochloride), put it in a 100ml measuring flask, add water to dissolve Cetirizine Hydrochloride and dilute it to the scale, shake well and filter it. Take 2ml of the filtrate, put it in a 50ml measuring flask, dilute it to the scale with water, shake it well, and use it as a sample solution for determination by UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at a wavelength of 231nm and a minimum absorption at a wavelength of 218nm. In the chromatogram recorded under
- Content determination, 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 aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
examination
- dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), hydrochloric acid solution (9-1000)900ml(10mg specification) or 500ml(5mg specification) 10ml of the solution was taken after 30 minutes, filtered, and then the filtrate was taken as the test solution. An appropriate amount of Cetirizine Hydrochloride reference was taken, precision weighing, plus hydrochloric acid solution (9-1000) dissolved and quantitatively diluted to each 1 ml containing about 10ug of the solution, as a reference solution. According to the chromatographic conditions under the content determination item, 10 u1 of each of the test solution and the reference solution are accurately measured and injected into the liquid chromatograph respectively to record the chromatogram, according to the external standard method, the dissolution amount of each particle was calculated by the peak area. The limit is 75% of the labeled amount and shall be in accordance with the provisions.
- Content uniformity take 1 capsule of this product, pour the content into lOOml(lOmg specification),50ml(5mg specification) measuring flask, wash the capsule shell with hydrochloric acid solution (9-1000), dissolve Cetirizine Hydrochloride, dilute to the scale with hydrochloric acid solution (9-1000), shake well, filter, Take 5ml of continuous filtrate and place it in 50ml measuring flask, add hydrochloric acid solution (9-1000) to dilute to the scale, shake well, as a test solution; Take the appropriate amount of Cetirizine Hydrochloride reference, precision weighing, with hydrochloric acid solution (9-1000) dissolve and quantitatively dilute to a solution containing approximately 1 ug per 1 ml as a control solution. Respectively take the above two kinds of solution, according to ultraviolet-visible spectrophotometry (General rule 0401) at the wavelength of 230mn absorbance determination, calculate the content, should comply with the provisions (General rule 0941).
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test with eighteen alkyl silane bonded silica gel as filler; O. 1 mol/L sodium dihydrogen phosphate solution (adjusted to pH 3.7 with phosphoric acid)-acetonitrile (60:40) as mobile phase; The detection wavelength was 232nm. The number of theoretical plates shall not be less than 2000 based on the calculation of cetirizine peak.
- The determination method is to take 20 capsules of this product, accurately weigh and calculate the average loading. Take the contents, mix them well, weigh an appropriate amount (about 10mg equivalent to Cetirizine Hydrochloride), put it in a 100ml measuring flask, add an appropriate amount of hydrochloric acid solution (9-1000), sonicate the Cetirizine Hydrochloride to dissolve and dilute to the scale, shake well, filter, discard the initial filtrate, and take the continued filtrate as the test solution; Accurately weigh the appropriate amount of Cetirizine Hydrochloride reference, and add hydrochloric acid solution (9-1000). Dissolved and quantitatively diluted to prepare 0.1 mg solution, as a control solution. 20ul of the test solution and the reference solution were respectively injected into the human liquid chromatograph, and the chromatograms were recorded. According to the external standard method to calculate the peak area, that is.
category
Same as Cetirizine Hydrochloride.
specification
(l)5mg (2)10mg
storage
light-shielded, sealed, and stored in a dry place.
Last Update：2022-01-01 14:22:45
Cetirizine hydrochloride - Cetirizine Dihydrochloride Oral Drops
Authoritative Data Verified Data
This product contains Cetirizine Hydrochloride (C21H25C1N203 • 2HC1) should be 90.0% ~ 110.0% of the label amount.
trait
This product is a colorless to yellowish clear liquid.
identification
- take an appropriate amount of this product and dilute it with water to make a solution of Φ20ug per lml, and measure by UV-Vis spectrophotometry (General rule 0401). There is maximum absorption at the wavelength of 231nm on the right, there is minimal absorption at a wavelength of 218nm.
- 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.
- This product chloride identification (1) of the reaction (General 0301).
examination
- the color of the solution of this product, with the yellow 4 standard colorimetric method (General Principles 0901 The first method) comparison, not deeper.
- others should comply with the relevant provisions under oral solution (Tongbei 0123).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test with eighteen alkyl silanes bonded to silicon as a filler; With O. 1 mol/L sodium dihydrogen phosphate solution (adjusted to pH 3.7 with phosphoric acid)-acetonitrile (60:40) as mobile phase, the detection wavelength was 232nm. The theoretical values are not less than 2000 as calculated from the cetirizine peak.
- determination precision: take an appropriate amount of this product and make it quantitatively diluted with water to make it contain Cetirizine Hydrochloride in every 1mg. 1mg of the solution, as the test solution; Another fine empty weighing Cetirizine Hydrochloride control appropriate amount, dissolved in water and quantitative dilution made 4LML containing 0. The lmg solution is used as the reference solution; 20ul of the test name solution and the reference solution are respectively injected into the liquid chromatograph, and the chromatogram is recorded according to the external standard method and the peak area is calculated.
category
with Cetirizine Hydrochloride.
specification
10ml:0.lg
storage
sealed and stored in a cool place.
Last Update：2022-01-01 14:22:46
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Product Name: Cetirizine Hydrochloride Visit Supplier Webpage Request for quotationCAS: 83881-52-1
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Multiple SpecificationsSpot supply
Product Name: Cetirizine Dihydrochloride Visit Supplier Webpage Request for quotationCAS: 83881-52-1
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Product Name: Cetirizine DI HCL Request for quotation
CAS: 83881-52-1
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: 83881-52-1
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
Multiple SpecificationsSpot supply
Product Name: Cetirizine Hydrochloride Visit Supplier Webpage Request for quotationCAS: 83881-52-1
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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