Benserazide hydrochloride - Names and Identifiers
Name | Benserazide hydrochloride
|
Synonyms | RO 4-4602 Beserazide HCl Benserazide HCL Benzaerazide Hcl Benserazide hydrochloride DL-serine 2-[(2,3,4-Trihydroxyphenyl)Methyl]Hydrazide HCL DL-SERINE 2-[(2,3,4-TRIHYDROXYPHENYL)METHYL]HYDRAZIDE HCL DL-SERINE 2[(2,3,4-TRIHYDROXYPHENYL)-METHYL] HYDRAZIDE HYDROCHLORIDE DL-serine 2[(2,3,4-Trihydroxyphenyl)-Methyl] Hydrazide hydrochloride 2-amino-3-hydroxy-N'-(2,3,4-trihydroxybenzyl)propionohydrazide hydrochloride 2-amino-3-hydroxy-N'-[(2,3,4-trihydroxyphenyl)methyl]propanehydrazide hydrochloride 2-azanyl-3-hydroxy-N'-[(2,3,4-trihydroxyphenyl)methyl]propanehydrazide hydrochloride
|
CAS | 14046-64-1 14919-77-8
|
EINECS | 238-991-9 |
InChI | InChI=1/C9H13N3O5.ClH/c10-8(16)9(17)12-11-3-4-1-2-5(13)7(15)6(4)14;/h1-2,8,11,13-16H,3,10H2,(H,12,17);1H |
Benserazide hydrochloride - Physico-chemical Properties
Molecular Formula | C10H16ClN3O5
|
Molar Mass | 293.7 |
Melting Point | 146℃ |
Boling Point | 574.2°C at 760 mmHg |
Solubility | H2O: 10 mg/mL. Soluble in water, slightly soluble in methanol, insoluble in ethanol or acetone. |
Appearance | solid |
Storage Condition | 2-8℃ |
Sensitive | Sensitive to light and easy to absorb moisture |
MDL | MFCD00078571 |
Use | Used as a decarboxylase inhibitor |
Benserazide hydrochloride - Risk and Safety
Hazard Symbols | Xi - Irritant
|
Risk Codes | 36/37/38 - 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.
|
WGK Germany | 2 |
RTECS | VT9632300 |
Benserazide hydrochloride - Standard
Authoritative Data Verified Data
This product is 2-[(2,3, 4-trihydroxyphenyl) methyl] hydrazide-DL-serine hydrochloride. The content of C10H15N305. HCI shall be between 95.0% and 102.0% based on the dry product.
Last Update:2024-01-02 23:10:35
Benserazide hydrochloride - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; It has hygroscopicity; It becomes darker in light.
- This product is soluble in water, slightly soluble in methanol, insoluble in ethanol or acetone.
Last Update:2022-01-01 15:04:35
Benserazide hydrochloride - Differential diagnosis
Authoritative Data Verified Data
- take a small amount of this product, put it in a clean test tube, add 2ml of water to dissolve it, and then add 1ml of ammonia silver nitrate test solution to make it brown. Heat it in a water bath, silver is free and attached to the inner wall of the tube to form a silver mirror.
- 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 infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1017).
- This product is chloride identification reaction (General 0301).
Last Update:2022-01-01 15:04:36
Benserazide hydrochloride - Exam
Authoritative Data Verified Data
optical rotation
take this product, add water to dissolve and quantitatively dilute to make a solution containing about 10 mg per lml, and determine it according to law (General rule 0621). The optical rotation should be 0.05 ° to +0.05 °.
acidity
take 0.10g 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 0.10g of this product and add 0401 of water to dissolve. The solution should be clear and colorless, the absorbance was measured at a wavelength of 435nm and should not exceed 0.04.
Related substances
take this product, add mobile phase to dissolve and dilute to make a solution containing about 1.5mg per 1 ml as a test solution; Take 2ml and put it in a 100ml measuring flask for precision measurement, 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, take 10 u1 of the test solution and the control solution, respectively inject the human liquid chromatograph, record the chromatogram to 2 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 (2.0%).
loss on drying
take this product, put it in a phosphorus pentoxide dryer, and dry it under reduced pressure at 60°C to constant weight, and the 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 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 15:04:36
Benserazide hydrochloride - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane was used as a filler; Trifluoroacetic acid-methanol-water (1:20:1000) was used as a mobile phase; The detection wavelength was 220nm. The number of theoretical plates shall not be less than 1000 based on the benserazide peak.
assay
take an appropriate amount of this product, precision weighing, and add mobile phase to dissolve and quantitatively dilute to make a solution containing about 0.3mg per lml (ready to use new), as a test solution, take 10u1 injection liquid chromatograph for precise measurement, record chromatogram; Take benserazide hydrochloride reference substance, same method for determination. According to the external standard method to calculate the peak area, that is.
Last Update:2022-01-01 15:04:37
Benserazide hydrochloride - Category
Authoritative Data Verified Data
decarboxylase inhibitors.
Last Update:2022-01-01 15:04:37
Benserazide hydrochloride - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update:2022-01-01 15:04:37
Benserazide hydrochloride - Levodopa and levodopa tablets
Authoritative Data Verified Data
This product contains levodopa (C9H11NO4) and benserazide hydrochloride (C10H15N3O5 • HC1) should be 90.0% ~ 110.0% of the label amount.
trait
This product is colored.
identification
- take 1 tablet of this product, grind, add 10ml of water, shake to dissolve levodopa and benserazide hydrochloride, filter, take 2ml of filtrate, put it in a clean test tube, add 1ml of silver nitrate test solution prepared by adding ammonia, it is Brown; Heated in a water bath, the silver is free and attached to the inner wall of the tube to form a silver mirror; Another 1ml of filtrate is taken, water is added to 20ml, 5ml of this solution is taken, and lml of 1% ninhydrin solution is added, after heating in a water bath, the solution gradually turned purple.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks in the test solution should be consistent with the retention time of the two main peaks in the control solution.
examination
- the contents of serazide hydrochloride and trihydroxybenzylbenseril hydrochloride were determined by the method under the item of determination, and the peak height and peak area were calculated by external standard method, the contents of serazide hydrochloride and trihydroxybenzyl benserazide hydrochloride shall not exceed 2.0% and 3.0% of the labeled amount of benserazide hydrochloride respectively.
- 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 octyl silane bonded silica gel as filler; 0.05 mol/L potassium dihydrogen phosphate solution-methanol-acetonitrile (70.5:25:4.5)(Containing 0.005mol/L sodium decylsulfonate) as mobile phase, pH was adjusted to 3.5 with phosphoric acid; The detection wavelength of levodopa was 270mn, and the detection wavelength was changed to 220nm after the peak of levodopa was complete. The theoretical plate number shall not be less than 1000 based on benserazide peak. The separation degree between levodopa peak, serazide peak, benserazide peak and trihydroxybenzyl benserazide peak shall meet the requirements.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (approximately equivalent to levodopa lOOmg and benserazide hydrochloride 28.5mg ), 200ml flask, plus mobile phase 180ml, sonication for 2 minutes, shaking for 15 minutes to dissolve levodopa and benserazide hydrochloride, dilute to the scale with mobile phase, shake, filter, and take the continued filtrate as the test solution, immediately take 20ul injection into human liquid chromatograph, record chromatogram; Take appropriate amount of each reference substance of serazide hydrochloride and trihydroxybenzyl benserazide hydrochloride, add mobile phase to dissolve and quantitatively dilute to make a solution containing about 0.285mg per lml; Then take about lOOmg of levodopa reference substance and about 28.5mg of benserazide hydrochloride reference substance, weigh them precisely and put them in the same 200ml measuring flask, add appropriate amount of mobile phase to shake to dissolve, add 2ml of the above-mentioned silk hydrazine hydrochloride solution and 3ml of trihydroxybenzyl benserazide hydrochloride solution precisely, dilute to scale with mobile phase, shake well, and measure with the same method. According to the external standard method to calculate the peak area, that is.
category
Anti-Parkinson's disease drugs.
specification
levodopa 200mg with benserazide 50mg (equivalent to benserazide hydrochloride 57mg)
storage
shade, seal, and store in a cool and dry place.
Last Update:2022-01-01 15:04:38
Benserazide hydrochloride - Dopa capsule
Authoritative Data Verified Data
This product contains levodopa (C9H11NO4) and benserazide hydrochloride (C10H15N3O5 • HCl) should be 90.0% ~ 110.0% of the label amount.
trait
The content of this product is white or white powder.
identification
- take about 0.5g of the contents of this product, Add 10ml of water to shake, dissolve levodopa and benserazide hydrochloride, filter, take 2ml of filtrate, and place it in a clean test medium, 1ml of silver nitrate test solution was prepared by adding ammonia, which was Brown. After heating in a water bath, the silver was deposited and attached to the inner wall of the tube to form a silver mirror, 1ml of 1% ninhydrin solution was added and heated in a water bath. The Solution turned purple.
- in the chromatogram recorded under the content determination item, the retention time of the two peaks in the test solution should be consistent with the retention time of the two main peaks in the control solution.
examination
- weight loss on drying the contents of this product are taken, placed in a phosphorus pentoxide 5 dryer, dried under reduced pressure at 60°C to constant weight, and the weight loss shall not exceed 1.0% (Tongbei 0831).
- 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 as filler; Trifluoroacetic acid-methanol-water (1:20:1000) as mobile phase; Barium detection wavelength of 220nm. The number of theoretical plates shall not be less than 1000 calculated by benserazide peak, and the separation degree between levodopa peak and benserazide peak shall meet the requirements.
- the contents under the item of loading difference were measured, mixed evenly, and the appropriate amount was accurately weighed (approximately equivalent to 28.5mg of levodopa and benserazide hydrochloride). In the S200ml measuring flask, the appropriate amount of mobile phase was added, shake the solution of levodopa and benserazide hydrochloride in benserazide Bay and dilute to the scale, shake well, filter, as a sample solution, take a 10ul precision liquid chromatograph, record the chromatogram; another L-dopa reference substance and benzathine hydrochloride with appropriate amount of reference substance, precision weighing, dissolved and quantitatively diluted with mobile phase to make a solution containing about 0.5mg and 0.15mg per 1 ml, and determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Anti-Parkinson's disease drugs.
specification
- levodopa lOOmg with benserazide 25mg (equivalent to benserazide gallate 28.5mg)
- levodopa 200mg with benserazide 50mg (equivalent to 57mg for benserazide hydrochloride)
storage
shade, seal, and store in a cool and dry place.
Last Update:2022-01-01 15:04:39