OXYBUTYNIN CHLORIDE
oxybutynin chloride
CAS: 1508-65-2
Molecular Formula: C22H32ClNO3
OXYBUTYNIN CHLORIDE - Names and Identifiers
| Name | oxybutynin chloride |
| Synonyms | ditropan OXYBUTYNIN HCL Oxybutynin HCL Oxybutynine hcl OXYBUTYNIN CHLORIDE oxybutynin chloride OXYBUTYNIN HYDROCHLORIDE Oxybutynin Hydrochloride 4-diethylamino-2-butynylphenyl(cyclohexyl)glycolatehydrochloride alpha-phenylcyclohexaneglycolicacid4-(diethylamino)-2-butynylesterhydroch cyclohexaneglycolicacid,alpha-phenyl-,4-(diethylamino)-2-butynylester,hydr A-PHENYLCYCLOHEXANEGLYCOLIC ACID 4-(DIETHYLAMINO)-2-BUTYNYL ESTER, HYDROCHLORIDE |
| CAS | 1508-65-2 |
| EINECS | 216-139-7 |
| InChI | InChI=1/C22H31NO3.ClH/c1-3-23(4-2)17-11-12-18-26-21(24)22(25,19-13-7-5-8-14-19)20-15-9-6-10-16-20;/h5,7-8,13-14,20,25H,3-4,6,9-10,15-18H2,1-2H3;1H |
OXYBUTYNIN CHLORIDE - Physico-chemical Properties
| Molecular Formula | C22H32ClNO3 |
| Molar Mass | 393.95 |
| Melting Point | 122-124°C |
| Boling Point | 494.4°C at 760 mmHg |
| Flash Point | 252.8°C |
| Solubility | H2O: soluble50mg/mL |
| Vapor Presure | 1.37E-10mmHg at 25°C |
| Appearance | powder |
| Color | white |
| Storage Condition | room temp |
| Physical and Chemical Properties | White Crystal or crystalline powder, melting point 124-129 ℃, dissolved in methanol or chloroform, dissolved in water, almost insoluble in n-hexane; Dissolved in glacial acetic acid. |
| Use | Antispasmodic drugs for the treatment of urinary urgency, urinary frequency, urinary incontinence, nocturia and enuresis |
OXYBUTYNIN CHLORIDE - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | 22 - Harmful if swallowed |
| Safety Description | 36 - Wear suitable protective clothing. |
| WGK Germany | 3 |
| RTECS | GV2800000 |
| HS Code | 29221990 |
| Toxicity | LD50 orally in rats: 1220 mg/kg (Goldenthal) |
OXYBUTYNIN CHLORIDE - Standard
Authoritative Data Verified Data
This product is a-cyclohexyl-a-hydroxyphenylacetic acid -4-diethylamino-2-butyl Ester hydrochloride. The content of C22H31N03 • HCl shall not be less than 98.0% calculated as dry product.
Last Update：2024-01-02 23:10:35
OXYBUTYNIN CHLORIDE - Trait
Authoritative Data Verified Data
- This product is white crystal or crystalline powder; Odorless.
- This product is soluble in methanol or chloroform, dissolved in water, almost insoluble in n-hexane; Dissolved in glacial acetic acid.
melting point
The melting point of this product (General 0612) is 124~129°C.
Last Update：2022-01-01 15:34:53
OXYBUTYNIN CHLORIDE - Differential diagnosis
Authoritative Data Verified Data
- take about 0.2g of this product, add 20ml of ethanol and 5ml of water to dissolve, add about 30mg of mercury sulfate and 10ml of 0.5mol / L sulfuric acid solution, stir to dissolve and cool, adjust the pH value to 6.0 with 2mol / L sodium hydroxide solution, and extract with 20ml of ether by shaking. The ether extract is dried on a water bath and evaporated, add 3ml of dinitrophenylhydrazine solution, shake, and boil in a water bath for 1 min to show orange color.
- take an appropriate amount of this product, add the mobile phase to dissolve and dilute to make about 0. A solution of 1 mg was used as a test solution; An appropriate amount of a reference product of oxybutynin hydrochloride was additionally taken and prepared in the same manner as a reference solution. According to the test method under the item of related substances, 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.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1032).
- This product is chloride identification reaction (General 0301).
Last Update：2022-01-01 15:34:54
OXYBUTYNIN CHLORIDE - Exam
Authoritative Data Verified Data
optical rotation
take this product, precision weighing, add water to dissolve and quantitatively dilute the solution containing about 0.10g per lml, according to the law (General 0621), optical rotation of a 0.10 ° to +0.10 °.
Related substances
take this product, add mobile phase to dissolve and dilute to make a solution containing about 1 mg per 1ml as a test solution; Take 1ml 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 high performance liquid chromatography (General rule 0512) test, with eighteen alkyl silane bonded silica gel as filler, phosphate buffer solution (take potassium dihydrogen phosphate 2.48g and potassium dihydrogen phosphate g, add water 1000ml to dissolve, the pH value was adjusted to 6.8 with 1 mol / L phosphoric acid)-methanol (15:85) as mobile phase, and the detection wavelength was 220nm. The number of theoretical plates shall not be less than 2000 calculated by oxybutynin peak, and the degree of separation between oxybutynin peak and adjacent impurity peak shall meet the requirements. Take 10 u1 of the test solution and the control solution respectively, inject the human liquid chromatograph, record the chromatogram 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 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 3.0% (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 0.1%.
Heavy metals
The residue left under the ignition residue item shall not contain more than 10 parts per million of heavy metals when examined by law (General rule 0821).
chlorine content
take this product about 0.6g, precision weighing, add water 5ml and glacial acetic acid 5ml to dissolve, add methanol 50ml and eosin indicator solution 5 drops, with silver nitrate titration solution (0.1 mol/L) titrated to red. Each 1 ml of silver nitrate titration solution (0.1 mol/L) is equivalent to 3.54mg of chlorine, and the chlorine content should be 8.0% ~ 10.0% based on the dry product.
Last Update：2022-01-01 15:34:54
OXYBUTYNIN CHLORIDE - Content determination
Authoritative Data Verified Data
take about 0701g of this product, precision weighing, add anhydrous glacial acetic acid 20ml to dissolve, add acetic anhydride 30ml, according to the potentiometric titration method (general rule), with perchloric acid titration solution (0.1 mol/L) titration, and the results of the titration were corrected with a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 39.40mg of C22H31N03. HCl.
Last Update：2022-01-01 15:34:55
OXYBUTYNIN CHLORIDE - Category
Authoritative Data Verified Data
antispasmodic.
Last Update：2022-01-01 15:34:55
OXYBUTYNIN CHLORIDE - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 15:34:55
OXYBUTYNIN CHLORIDE - Oxybutynin hydrochloride tablets
Authoritative Data Verified Data
This product contains oxybutynin hydrochloride (C22H31N03 • HCl) should be 90.0% ~ 110.0% of the label amount.
trait
This product is white or off-white.
identification
- take an appropriate amount of the fine powder of this product (equivalent to oxybutynin hydrochloride 50mg ), add chloroform 10ml, grind to dissolve oxybutynin hydrochloride, filter, take the filtrate as the test solution, and take oxybutynin hydrochloride control 50mg, chloroform (10ml) was added to dissolve as a control solution. According to the thin layer chromatography (General 0502) test, absorb 10 u1 of each of the above two solutions, respectively point on the same silica gel G thin layer plate, with methanol as the developing solvent, expand, dry, the position and color of the main spot of the test solution should be the same as the main spot 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.
- items (1) and (2) above are optional.
examination
- Related substances take an appropriate amount of the fine powder of this product (about 25mg of oxybutynin hydrochloride), put it in a 25ml measuring flask, add an appropriate amount of mobile phase, shake to dissolve oxybutynin hydrochloride, dilute to the scale with mobile phase, and shake 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 method of oxybutynin hydrochloride related substances. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be more than 2 times (2.0%) of the main peak area of the control solution.
- Content uniformity take 1 tablet of this product, put it in a 25ml measuring flask, add 7.5 ml of methanol, shake to dissolve oxybutynin hydrochloride, dilute to the scale with mobile phase, shake, filter, determination of content according to the method under the content determination item, should comply with the provisions (General 0941).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), water 500ml as the dissolution medium, the speed of 50 rpm, according to the law, after 45 minutes, take 10ml solution, filter, take the filtrate, according to the content determination
- Under the chromatographic conditions, the precise amount of 20u1 injection of human liquid chromatography, record the chromatogram; Another oxybutynin hydrochloride reference substance, precise weighing, water was added to dissolve and quantitatively diluted to prepare a solution containing about 10ug per 1 ml, which was determined by the same method. The dissolution amount of each tablet was calculated by the peak area according to the external standard method. 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
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Phosphate buffer (take potassium dihydrogen phosphate 1.94g and dipotassium hydrogen phosphate 2.48g, add water 1000 to dissolve, adjust pH to 6.8 with 1 mol / L phosphoric acid)-methanol (15:85) as mobile phase; The detection wavelength was 220mn. The number of theoretical plates shall not be less than 2000 calculated by oxybutynin peak, and the degree of separation between oxybutynin peak and adjacent impurity peak shall meet the requirements.
- determination of 20 tablets of this product, precision weighing, fine, precision weighing an appropriate amount (about 1O mg equivalent to oxybutynin hydrochloride), put it in a 50ml measuring flask, add methanol 15ml, the oxybutynin hydrochloride was dissolved by shaking, diluted to the scale with mobile phase, shaken, filtered, and the filtrate was taken as the test solution. A 10ul injection liquid chromatograph was accurately measured, and the chromatogram was recorded; in addition, take 10mg of the reference product of oxybutynin hydrochloride, put it in a 50ml measuring flask, add 15ml of methanol, shake to dissolve, dilute to the scale with mobile phase, shake well, and determine by the same method, and calculate by peak area according to external standard method, that's right.
category
with oxybutynin hydrochloride.
specification
5mg
storage
sealed storage.
Last Update：2022-01-01 15:34:56
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