5,5-diphenylhydantoin sodium sigmaultra

5,5-diphenylhydantoin sodium sigmaultra - Names and Identifiers

Name	5,5-diphenylhydantoin sodium sigmaultra
Synonyms	solantyl solantoin dilantinsodium Phenytoin Sodium 5,5-DIPHENYLHYDANTOIN SODIUM 5,5-Diphenylhydatoin sodium salt 5,5-DIPHENYLHYDANTOIN SODIUM SALT 4-Ethyloctanoic acid methyl ester 5,5-diphenyl-hydantoimonosodiumsalt 5,5-diphenylhydantoinsodiumsigmaultra 5,5-diphenylhydantoin sodium sigmaultra 4-imidazolidinedione,5,5-diphenyl-monosodiumsalt
CAS	630-93-3
EINECS	211-148-2
InChI	InChI=1/C15H12N2O2.Na/c18-13-15(17-14(19)16-13,11-7-3-1-4-8-11)12-9-5-2-6-10-12;/h1-10H,(H2,16,17,18,19)
InChIKey	FJPYVLNWWICYDW-UHFFFAOYSA-M

5,5-diphenylhydantoin sodium sigmaultra - Physico-chemical Properties

Molecular Formula	C15H13N2NaO2
Molar Mass	276.27
Melting Point	290-299°C
Boling Point	428.2 °C at 760 mmHg
Solubility	Easily soluble in water, soluble in ethanol, almost insoluble in ether and chloroform.
Appearance	White powder
Color	White to almost white
Merck	14,7322
Storage Condition	Inert atmosphere,Room Temperature
Sensitive	Easily absorbing moisture
MDL	MFCD00069674
Physical and Chemical Properties	White powder, odorless. Melting Point 290-299 °c. Placed in the air can absorb moisture and carbon dioxide, the precipitation of phenytoin. Soluble in ethanol, water, insoluble in chloroform and ether.
Use	Commonly used antiepileptic, treatment of trigeminal neuralgia and sciatica, antiarrhythmic and lowering blood pressure.

5,5-diphenylhydantoin sodium sigmaultra - Risk and Safety

Hazard Symbols	Xn - Harmful
Risk Codes	R22 - Harmful if swallowed R43 - May cause sensitization by skin contact R62 - Possible risk of impaired fertility R63 - Possible risk of harm to the unborn child
Safety Description	S22 - Do not breathe dust. S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.)
UN IDs	UN 2811 6.1/PG 3
WGK Germany	3
RTECS	MU1400000
HS Code	29332100
Hazard Class	6.1(b)
Packing Group	III
Toxicity	LD50 orally in mice: 490 mg/kg (Fink, Swinyard)

5,5-diphenylhydantoin sodium sigmaultra - Reference

Reference

1. Lu Haimei, Xie Meijuan, Li Shan, et al. Improvement of 6Hz corneal kindling drug-resistant epilepsy mouse model and effects of three traditional Chinese medicines [J]. Chinese Journal of Pharmacy, 2018, 053(007):1048-1053.
2. [IF = 2.196] Yang Lv et al."Central inhibition the in vivo acute toxicity of harmine in mice." Journal Of Biological Sciences. 2021 Jun 01

5,5-diphenylhydantoin sodium sigmaultra - Standard

Authoritative Data Verified Data

This product is 5, 5-diphenylhydantoin sodium salt. The content of C15H11N2NaO2 shall be between 98.0% and 102.0% based on the dry product.

Last Update：2024-01-02 23:10:35

5,5-diphenylhydantoin sodium sigmaultra - Trait

Authoritative Data Verified Data

This product is white powder; Odorless; Slightly hygroscopic; Gradually absorbed carbon dioxide in the air, decomposed into phenytoin; Aqueous solution alkaline reaction, often due to partial hydrolysis and turbidity.
This product is soluble in water, soluble in ethanol, almost insoluble in chloroform or ether.

Last Update：2022-01-01 13:34:00

5,5-diphenylhydantoin sodium sigmaultra - Introduction

Odorless, bitter taste; slightly hygroscopic; gradually absorb carbon dioxide in the air and decompose into phenytoin; the aqueous solution is an alkaline reaction, often due to partial hydrolysis and turbidity; soluble in water and ethanol, insoluble in chloroform or ether.

Last Update：2022-10-16 17:27:30

5,5-diphenylhydantoin sodium sigmaultra - Differential diagnosis

Authoritative Data Verified Data

take about 1. Og of this product, add 2ml of water to dissolve, add a few drops of second gasification Mercury test solution to generate white precipitate, which is insoluble in ammonia test solution.
take about 10mg of this product, add 10mg of potassium permanganate, 0.25g of sodium hydroxide and 10ml of water, heat for 5 minutes, let cool, take 5ml of supernatant, add 20ml of n-heptane, and extract with shaking, after the layers were allowed to stand, the n-heptane extract was taken and measured by UV-Vis spectrophotometry (General rule 0401), which showed a maximum absorption at a wavelength of Nm.
take about 150mg of this product, add water 20ml to dissolve, add 3mol/L hydrochloric acid solution 5ml, add chloroform 20ml to extract, separate the chloroform layer, wash the three gas methane layer with water 20ml, take the three-gas methane solution, put the water bath to dry, and dry the residue at 105 ° C. For 1 hour. The infrared absorption spectrum of the residue should be consistent with that of phenytoin reference substance (General rule 0402).
This product shows the reaction of sodium salt identification (1) (General rule 0301).

Last Update：2022-01-01 13:34:01

5,5-diphenylhydantoin sodium sigmaultra - Exam

Authoritative Data Verified Data

clarity and color of solution

take 0.5g of this product, add 20ml of water to dissolve, add 2ml of 0.4% sodium hydroxide solution, the solution should be clear and colorless.

Related substances

take this product, add the mobile phase to dissolve and dilute to make a solution containing about 1 mg per 1 ml, as a test solution; Take an appropriate amount of precision, A solution containing 10ug per 1 ml was prepared as a control solution by quantitative dilution with mobile phase. According to the chromatographic conditions under the content determination item, 20ul of each of the control solution and the test 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. 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 should not exceed 2.0% (for injection) or 2.5% (for oral use) (General 0831).

Heavy metals

take 2.og of this product, add 37ml of water, boil and dissolve, let it cool, add 2.5ml of dilute hydrochloric acid, shake and filter; Take 20ml of filtrate, add 1 drop of phenolphthalein indicator solution and an appropriate amount of ammonia test solution to make the solution light red, add 2ml of acetate buffer solution (pH 3.5) and an appropriate amount of water to make 25ml, and check according to law (General rule 0821 method 1), heavy metals should not be more than 10 parts per million.

sterile

take this product, add 20ml of sterile water to dissolve, check according to law (General rule 1101), should comply with the provisions. (For aseptic dispensing)

Last Update：2022-01-01 13:34:01

5,5-diphenylhydantoin sodium sigmaultra - 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 was used as the filler, and 0.05mol/L ammonium dihydrogen phosphate solution (adjusted to pH 2.5 with phosphoric acid)-acetonitrile-methanol (45:35:20) was used as the mobile phase; the flow rate was 1.5ml per minute; The detection wavelength was 220nm. Take appropriate amount of 2-hydroxy-1, 2-diphenylethanone (impurity I) and phenytoin sodium control, add a small amount of methanol to dissolve, diluted with mobile phase to produce impurities of approximately 10.15mg with phenytoin in 1 ml. The mixed solution of lmg is injected into the liquid chromatograph, and the peak sequence is phenytoin sodium and impurity I. The separation degree between the two peaks shall meet the requirements, and the number of theoretical plates shall not be less than 5000 based on the phenytoin sodium peak.

assay

take this product, precision weighing, adding mobile phase to dissolve and dilute to make a solution containing about 50ug per lml, take 20ul for precision measurement, inject into liquid chromatography, record chromatogram; Take phenytoin sodium reference substance, same method determination. According to the external standard method to calculate the peak area, that is.

Last Update：2022-01-01 13:34:02

5,5-diphenylhydantoin sodium sigmaultra - Category

Authoritative Data Verified Data

antiepileptic drugs, antiarrhythmic drugs.

Last Update：2022-01-01 13:34:02

5,5-diphenylhydantoin sodium sigmaultra - Storage

Authoritative Data Verified Data

sealed (for oral use) or sealed (for injection), protected from light.

Last Update：2022-01-01 13:34:03

5,5-diphenylhydantoin sodium sigmaultra - Phenytoin Sodium Tablets

Authoritative Data Verified Data

This product contains phenytoin sodium (C15H11N2NaO2) should be labeled the amount of 93.0% to 107.0%.

trait

This product is white tablet or film-coated tablet.

identification

take an appropriate amount of fine powder of this product (about equivalent to 1g of phenytoin sodium), add 20ml of water, impregnate the phenytoin sodium to dissolve, filter; Filtrate identification under phenytoin sodium (1), (2) one test showed the same result; Another part of the filtrate was taken and evaporated to dryness, and the residue showed the same reaction according to the identification (4) test under phenytoin sodium.
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.

examination

appropriate amount of fine powder under the content determination item is taken, dissolved and diluted with mobile phase to prepare a solution containing 1 mg of phenytoin sodium per 1 ml, filtered through a filter membrane, and used as a test solution; A solution containing 10ug of sodium phenytoin per 1 ml was prepared as a control solution by quantitatively diluting an appropriate amount with the mobile phase. The determination was carried out according to the method for related substances of phenytoin sodium. If there are impurity peaks in the chromatogram of the test solution, the sum of the peak areas of each impurity shall not be greater than the main peak area of the control solution (0.3) except for the chromatographic peaks before the relative retention time of 1.0%.
the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), with water as the dissolution medium, the speed is 100 rpm, according to the law, after 45 minutes, filter the solution, and measure the absorbance at the wavelength of 258nm according to UV-Vis spectrophotometry (General rule 0401), water was added to dissolve and quantitatively diluted to prepare a solution containing about 0.1 mg(50mg specification) or 0.2mg (10 mg specification) per 1 ml, and the dissolution amount of each tablet was calculated by the same method. The limit is 75% 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

Take 20 tablets of this product, precision weighing, fine grinding, precision weighing appropriate amount (equivalent to phenytoin sodium 25mg), put it in 50ml measuring flask, add appropriate amount of mobile phase, shake for 30 minutes to dissolve phenytoin sodium, dilute to scale with mobile phase, shake well, filter, Take 5ml of filtrate accurately, put it in 50ml measuring flask, dilute to scale with mobile phase, shake well, as a test solution, 20 u1 was accurately measured, and human liquid chromatograph was injected to record the chromatogram. An appropriate amount of phenytoin sodium reference was additionally taken, the mobile phase was added and dissolved and diluted to prepare a solution containing about 50ug per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.

5,5-diphenylhydantoin sodium sigmaultra - Phenytoin sodium for injection

Authoritative Data Verified Data

This product is a sterile powder of phenytoin sodium 10 parts mixed with anhydrous sodium carbonate 4 parts. Based on the average loading, the content of phenytoin sodium C15H11N2NaO2 shall be 93.0% to 107.0% of the labeled amount.

trait

This product is white powder.

identification

take an appropriate amount of this product (about 50mg equivalent to phenytoin sodium), add 5ml of water to dissolve phenytoin sodium, Dropwise add dilute sulfuric acid to precipitate phenytoin, and filter; the precipitate is dissolved by adding 8-10 drops of 1 ml of water and 0.4% sodium hydroxide solution, and a few drops of mercury dichloride test solution are added to form a white precipitate, which is insoluble in the ammonia test solution.
the same results were obtained according to the tests (2) and (4) in the case of phenytoin sodium.
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.

examination

alkalinity: take 0.35g of this product, Add 10ml of water to dissolve it, and measure it according to law (General rule 0631). The pH value should be 9.5~11.5.
the contents under the item of difference in loading amount of related substances shall be mixed evenly, the appropriate amount shall be accurately weighed, and the mobile phase shall be added to make a solution containing 1 mg of phenytoin sodium per 1 ml, which shall be used as the test solution; an appropriate amount was taken in a precise amount and quantitatively diluted with the mobile phase to prepare a solution containing log per 1 ml as a control solution. The determination was carried out according to the method for related substances of phenytoin sodium. 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%).
weight loss on drying this product shall be dried at 105°C to constant weight, and the weight loss shall not exceed 2.5% (General rule 0831).
sterile take this product, respectively, plus sterile water made per lml solution containing 25mg, according to the law (General Principles 1101), should comply with the provisions.
others should comply with the relevant provisions under injection (General 0102).

Content determination

take the contents under the difference of loading amount, mix evenly, accurately weigh appropriate amount (about 25mg equivalent to phenytoin sodium), put it in a 50ml measuring flask, and add appropriate amount of mobile phase, shake to dissolve phenytoin sodium, dilute to the scale with mobile phase, shake well, take 5ml accurately, put it in a 50ml measuring flask, dilute to the scale with mobile phase, shake well, and use it as a test solution, 20 u1 was accurately measured, and the liquid chromatograph was injected to record the chromatogram. An appropriate amount of phenytoin sodium reference substance was accurately weighed, dissolved and diluted with mobile phase to prepare a solution containing about 50ul per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.

specification

(1)0.lg (2)0.25g

storage

light shielding, closed storage.

Last Update：2022-01-01 13:34:05

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Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog

Shanghai Yuanye Bio-Technology Co., Ltd.

Multiple SpecificationsSpot supply

Product Name: 5,5-Diphenylhydantoin sodium salt Visit Supplier Webpage Request for quotation
CAS: 630-93-3
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409

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5,5-diphenylhydantoin sodium sigmaultra

5,5-diphenylhydantoin sodium sigmaultra Request for Quotation

5,5-diphenylhydantoin sodium sigmaultra

CAS: 630-93-3

Molecular Formula: C15H13N2NaO2

5,5-diphenylhydantoin sodium sigmaultra - Names and Identifiers

5,5-diphenylhydantoin sodium sigmaultra - Physico-chemical Properties

5,5-diphenylhydantoin sodium sigmaultra - Risk and Safety

5,5-diphenylhydantoin sodium sigmaultra - Reference

5,5-diphenylhydantoin sodium sigmaultra - Standard

Authoritative Data Verified Data

5,5-diphenylhydantoin sodium sigmaultra - Trait

Authoritative Data Verified Data

5,5-diphenylhydantoin sodium sigmaultra - Introduction

5,5-diphenylhydantoin sodium sigmaultra - Differential diagnosis

Authoritative Data Verified Data

5,5-diphenylhydantoin sodium sigmaultra - Exam

Authoritative Data Verified Data

clarity and color of solution

loss on drying

Heavy metals

sterile

5,5-diphenylhydantoin sodium sigmaultra - Content determination

Authoritative Data Verified Data

chromatographic conditions and system suitability test

assay

5,5-diphenylhydantoin sodium sigmaultra - Category

Authoritative Data Verified Data

5,5-diphenylhydantoin sodium sigmaultra - Storage

Authoritative Data Verified Data

5,5-diphenylhydantoin sodium sigmaultra - Phenytoin Sodium Tablets

Authoritative Data Verified Data

trait

identification

examination

Content determination

category

specification

storage

5,5-diphenylhydantoin sodium sigmaultra - Phenytoin sodium for injection

Authoritative Data Verified Data

trait

identification

examination

Content determination

category

specification

storage

Supplier List

5,5-diphenylhydantoin sodium sigmaultra