SIRDALUD
TIZANIDINE HCL
CAS: 64461-82-1
Molecular Formula: C9H9Cl2N5S
SIRDALUD - Names and Identifiers
| Name | TIZANIDINE HCL |
| Synonyms | ZANAFLEX TERNELIN SIRDALUD TIZANIDINE HCL Tizanidine Hydrochloride TIZANIDINE HYDROCHLORIDE 5-chloro-N-(4,5-dihydro-1H-imidazol-2-yl)-2 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazolehydrochloride 1,3-benzothiadiazol-4-amine,5-chloro-n-(4,5-dihydro-1h-imidazol-2-yl)-mono |
| CAS | 64461-82-1 |
| InChI | InChI=1/C9H8ClN5S.ClH/c10-5-1-2-6-8(15-16-14-6)7(5)13-9-11-3-4-12-9;/h1-2H,3-4H2,(H2,11,12,13);1H |
SIRDALUD - Physico-chemical Properties
| Molecular Formula | C9H9Cl2N5S |
| Molar Mass | 290.17 |
| Melting Point | 280 °C |
| Boling Point | 391.2°C at 760 mmHg |
| Flash Point | 9℃ |
| Solubility | H2O: ~29mg/mL |
| Vapor Presure | 2.51E-06mmHg at 25°C |
| Appearance | solid |
| Color | white |
| Merck | 14,9485 |
| Storage Condition | Inert atmosphere,Room Temperature |
| Physical and Chemical Properties | Tizanidine hydrochloride is an imidazoline-meta-diazabtogether derivative with a molecular weight of 290.17. The structure is similar to clonidine. The melting point was 280 °c. |
| Use | This product is for scientific research only and shall not be used for other purposes. |
SIRDALUD - 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. S37/39 - Wear suitable gloves and eye/face protection |
| UN IDs | UN1230 - class 3 - PG 2 - Methanol, solution |
| WGK Germany | 3 |
| RTECS | DK9910000 |
| HS Code | 2934990002 |
SIRDALUD - Standard
Authoritative Data Verified Data
This product is 5-chloro-4-[(2-imidazolin-2-yl) amino]-2,1, 3-benzothiadiazole hydrochloride. The content of C9H8C1N5S • HCl shall be between 98.5% and 102.0% calculated as the dry product.
Last Update：2024-01-02 23:10:35
SIRDALUD - Trait
Authoritative Data Verified Data
- This product is white to light yellow crystalline powder; Odorless.
- this product in water, methanol and 0.1 mol/ L hydrochloric acid solution dissolved in ethanol and O. 1 mol/ L sodium hydroxide solution is very slightly soluble; It is almost insoluble in chloroform and ethyl acetate.
Last Update：2022-01-01 15:34:10
SIRDALUD - Differential diagnosis
Authoritative Data Verified Data
- take an appropriate amount of this product, add 0.lmol/L hydrochloric acid solution to dissolve and dilute to prepare a solution containing about 10ug per lml, and measure it by UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at wavelengths of 227nm and 320nm.
- The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 15:34:10
SIRDALUD - Exam
Authoritative Data Verified Data
acidity
take an appropriate amount of this product, add water to dissolve and dilute to make a solution containing about 20mg per lml, and determine it according to law (General rule 0631). The pH value should be 3.5~5.0.
Related substances
take an appropriate amount of this product, add the mobile phase to dissolve and dilute to make a solution containing about lmg per lml, shake well, and use it as a test solution; Take lml for precision measurement, and put it in a 500ml 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 test solution and the control solution are respectively injected into the liquid chromatograph, and the chromatogram is recorded to 11 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 (0.1%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 1.5 times (0.3%) of the main peak area of the control solution.
residual solvent
take this product about 0.1g, precision weighing, put in 20ml headspace bottle, precision add water lml to dissolve, seal, as a test solution; Take Tetrahydrofuran, methanol, the appropriate amount of ethanol and three gas methane is precisely weighed, and water is added to make a mixed solution containing about 72ug of tetrahydrofuran, 0.3mg of methanol, 0.5mg of ethanol and 6ug of chloroform in each lml, take 1ml of precision, put in 20ml headspace bottle, sealed, as a reference solution. According to the determination method of residual solvent (General 0 861 second method), polyethylene glycol (PEG-20M) (or polar similar) is used as the stationary liquid; The initial temperature is 40 C, and the maintenance time is 8 minutes, the temperature was increased to 120°C at a rate of 20°C per minute for 3 minutes; The detector temperature was 250°C, the inlet temperature was 220°C; The equilibrium temperature of the headspace bottle was 80°C, the equilibration time was 30 minutes. Take the reference solution into the headspace, record the chromatogram, and the separation degree of each component peak shall meet the requirements. The test solution and the reference solution were injected by Headspace, and the chromatograms were recorded. Based on the peak area calculated by external standard method, the residues of tetrahydrofuran, methanol, ethanol and three gas methane shall be in accordance with the provisions.
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
This product l.O g, inspection according to law (General 0841), residue shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 15:34:11
SIRDALUD - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with OCTA alkyl silane as filler; Sodium pentanesulfonate solution (take sodium pentanesulfonate 3.5g, dissolve in 3.0±0.05 ml of water, adjust pH to with phosphoric acid solution or sodium hydroxide solution)-acetonitrile (80:20) as mobile phase; The detection wavelength was 230nm. The number of theoretical plates is not less than 2000 based on tizanidine peak.
assay
take an appropriate amount of this product, precision weighing, adding mobile phase to dissolve and quantitatively dilute to make a solution containing about 20ug of tizanidine hydrochloride per lml. Take 20u1 injection of human liquid chromatograph for precision measurement, the chromatogram was recorded; Another tizanidine hydrochloride reference substance was used for precise weighing and determination by the same method. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 15:34:12
SIRDALUD - Category
Authoritative Data Verified Data
antispasmodic.
Last Update：2022-01-01 15:34:12
SIRDALUD - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 15:34:12
SIRDALUD - Tizanidine hydrochloride tablets
Authoritative Data Verified Data
This product contains tizanidine hydrochloride according to the calculation of tizanidine (C9H8C1N5S), should be 90.0% ~ 110.0% of the label amount.
trait
This product is white to off-white tablets.
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.
- take an appropriate amount of fine powder of this product, Add 10ml of water, shake to dissolve tizanidine hydrochloride, filter, and the filtrate shows chloride to identify the reaction of (1) (General rule 0301).
examination
- relevant substances: take an appropriate amount of this product, add mobile phase to dissolve tizanidine hydrochloride and dilute it to prepare about 0% tizanidine per 1ml. 1 mg of the solution, shake, filter, take the filtrate as the test solution; Take 1ml of precision, put 200ml flask, dilute to the scale with mobile phase, shake, 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 respectively injected into the liquid chromatograph, and the chromatogram is recorded to 11 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 0.4 times (0.2%) 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 (0.5%).
- Content uniformity: Take 1 tablet of this product, put it in 50ml measuring flask (lmg specification), 100ml measuring flask (2mg specification) or 200ml measuring flask (4mg specification), and add appropriate amount of mobile phase, tizanidine hydrochloride was dissolved by ultrasound, diluted to scale with mobile phase, shaken, filtered, and the continued filtrate was taken as the test solution, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 20ug tizanidine per 1 ml as a control solution. Determination of content according to the method under the content determination item, should comply with the provisions (General 0941).
- dissolution dissolution of this product, according to the dissolution and release determination method (General 0931 second method), hydrochloric acid solution (9-1000 ) 900ml as the dissolution medium, the rotation speed is 50 rpm, according to the law, after 15 minutes, 10ml of the solution was taken, filtered, and the filtrate was taken as the test solution, and the content was measured according to the method under the item of content determination. Another tizanidine hydrochloride reference, precision weighing, plus hydrochloric acid solution (9-1000) dissolved and quantitatively diluted into each lml containing tizanidine lug(1mg specification), 2ug(2mg specification) or 4ug ( 4mg specifications) of the solution, the same method. The dissolution amount of each tablet was calculated by the peak area according to the external standard method. The limit shall be 80% of the labeled amount and shall be in accordance with the regulations.
- 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 gel as filler; Sodium pentanesulfonate solution (3.5g of sodium pentanesulfonate, dissolved in 1000ml of water, the pH value was adjusted to 3.0±0.05 with phosphoric acid solution or sodium hydroxide solution. The mobile phase was acetonitrile (80:20) and the detection wavelength was 230nm. The number of theoretical plates is not less than 2000 based on tizanidine peak.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 2mg equivalent to tizanidine), put in a 100ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake, filter, take the filtrate as the test solution, take the precision amount of 20u1 injection of human chromatography, record the chromatogram; Take the control of tizanidine hydrochloride, precision weighing, dissolving and quantitatively diluting with mobile phase to make a solution containing about 20ug tizanidine per 1 ml, and measuring with the same method. According to the external standard method to calculate the peak area, that is.
category
Same as tizanidine hydrochloride.
specification
Based on C9H8C1N5S (l)lmg (2)2mg (3)4Mg
storage
sealed storage.
Last Update：2022-01-01 15:34:13
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Product Name: Tizanidine Hydrochloride Visit Supplier Webpage Request for quotationCAS: 64461-82-1
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
Spot supply
Product Name: Tizanidine Hydrochloride Visit Supplier Webpage Request for quotationCAS: 64461-82-1
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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