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L-VALINE 2-[(2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9YL)METHOXY]ETHYL ESTER, HYDROCHLORIDE SALT

Valaciclovir HCl

CAS: 124832-27-5;136489-37-7

Molecular Formula: C13H21ClN6O4

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  5. L-VALINE 2-[(2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9YL)METHOXY]ETHYL ESTER, HYDROCHLORIDE SALT

L-VALINE 2-[(2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9YL)METHOXY]ETHYL ESTER, HYDROCHLORIDE SALT - Names and Identifiers

Name Valaciclovir HCl
Synonyms Valtrex
Valaciclovir HCl
Valacyclovir hcl
valacyclover hydrochloric
valacycloverhydrochloride
valacyclovir hydrochloride
valaciclovir hydrochloride
L-Valacyclovir Hydrochloride
Valacyclovir Hydrochloride (200 mg)
9-((2-hydroxy-ethoxy)methyl)guanine l-valine ester hydrochloride
9-((2-Hydroxy-ethoxy)methyl)guanine L-valine ester hydrochloride
2-[(2-amino-6-oxo-3,6-dihydro-9H-purin-9-yl)methoxy]ethyl L-valinate
l-valine 2-[(2-amino-1,6-dihydro-6-oxo-9h-purin-9yl)methoxy]ethyl ester, hydrochloride salt
l-valine -2-[(2-amino-1,6-dihydro-6-oxo-9h-purin-9-yl) methoxy]ethylester monohydrochloride
(S)-2-((2-AMINO-6-OXO-1H-PURIN-9(6H)-YL)METHOXY)ETHYL 2-AMINO-3-METHYLBUTANOATE HYDROCHLORIDE
2-[(2-azanyl-6-oxo-3H-purin-9-yl)methoxy]ethyl (2S)-2-azanyl-3-methyl-butanoate hydrochloride
l-valine 2-[(2-amino-1,6-dihydro-6-oxo-9h-purin-9yl)methoxy]ethyl ester, hydrochlroride salt,
VALACYCLOVIR HYDROCHLORIDE [9-((2-HYDROXY-ETHOXY)MET HYL)GUANINE L-VALINE ESTER HYDROCHLORIDE]
L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride (9CI)
l-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9h-purin-9-yl)methoxy]ethyl ester, monohydrochloride (9ci)
CAS 124832-27-5
136489-37-7
EINECS 641-092-8
InChI InChI=1/C13H20N6O4/c1-7(2)8(14)12(21)23-4-3-22-6-19-5-16-9-10(19)17-13(15)18-11(9)20/h5,7-8H,3-4,6,14H2,1-2H3,(H3,15,17,18,20)/t8-/m0/s1

L-VALINE 2-[(2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9YL)METHOXY]ETHYL ESTER, HYDROCHLORIDE SALT - Physico-chemical Properties

Molecular FormulaC13H21ClN6O4
Molar Mass360.8
Density1.55g/cm3
Melting Point170-172°C
Boling Point588.4°C at 760 mmHg
Flash Point309.7°C
Solubility Soluble in Water: >20 mg/mL
Vapor Presure7.95E-14mmHg at 25°C
AppearanceWhite solid
Colorwhite
Maximum wavelength(λmax)['253nm(H2O)(lit.)']
Merck14,9899
Storage ConditionKeep in dark place,Sealed in dry,Store in freezer, under -20°C
StabilityHygroscopic
Refractive Index1.673
MDLMFCD01861507
UseFor anti-virus, anti-hepatitis, etc

L-VALINE 2-[(2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9YL)METHOXY]ETHYL ESTER, HYDROCHLORIDE SALT - Risk and Safety

Risk CodesR36/37/38 - Irritating to eyes, respiratory system and skin.
R22 - Harmful if swallowed
Safety DescriptionS26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S36 - Wear suitable protective clothing.
S24/25 - Avoid contact with skin and eyes.
UN IDs3077
WGK Germany3
HS Code29335990

L-VALINE 2-[(2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9YL)METHOXY]ETHYL ESTER, HYDROCHLORIDE SALT - Standard

Authoritative Data Verified Data

This product is L-valine -2-[(6-oxo-2-amino -1, 6-dihydro-9-phenanopurine -9-yl) methoxy] ethyl ester hydrochloride. The content of C13H20N604 • HCl shall not be less than 98.0% calculated as anhydrous.

Last Update：2024-01-02 23:10:35

L-VALINE 2-[(2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9YL)METHOXY]ETHYL ESTER, HYDROCHLORIDE SALT - Trait

Authoritative Data Verified Data
  • This product is white or off-white crystalline powder; Odorless; With hygroscopicity.
  • This product is soluble in water, slightly soluble in methanol, slightly soluble in ethanol, insoluble in dichloromethane.

specific rotation

take this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing about 40mg per lml, and determine according to law (General rule 0621), the specific rotation was -8.5 ° to -11.5 °.

Last Update：2022-01-01 14:23:03

L-VALINE 2-[(2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9YL)METHOXY]ETHYL ESTER, HYDROCHLORIDE SALT - Differential diagnosis

Authoritative Data Verified Data
  1. 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.
  2. The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1013).
  3. the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 14:23:03

L-VALINE 2-[(2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9YL)METHOXY]ETHYL ESTER, HYDROCHLORIDE SALT - Exam

Authoritative Data Verified Data

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 4.0~6.0.

Related substances

take the right amount of this product, precision weighing, plus O.Olmol/L potassium dihydrogen phosphate solution (adjusted to pH 3.0 with phosphoric acid) is dissolved and diluted to prepare a solution containing about 0.5mg per lml as a test solution, in a 0.01 measuring flask, dilute to the scale with the above 3.0 mol/L potassium dihydrogen phosphate solution (pH), shake well, and use it as a control solution; Take about 15mg of acyclovir reference substance, and weigh it precisely, in a 50ml measuring flask, add 0.1mol/L sodium hydroxide solution (2ml) was dissolved, then diluted with water to scale, and then shaken well as the reference stock solution of acyclovir, the mixture was diluted to the mark with the above 0.01mol/L potassium dihydrogen phosphate solution (pH 3.0) and shaken to obtain a control solution of acyclovir. According to the chromatographic conditions under the content determination item, the control solution, the acyclovir reference solution and the test solution are respectively accurately measured at 20 u1, and the human liquid chromatograph is respectively injected, the chromatogram was recorded to 6 times the peak retention time of valacyclovir. If there are impurity peaks in the chromatogram of the test solution, the content of acyclovir shall not exceed 1.5% calculated by the peak area according to the external standard method; The sum of other impurity peak areas shall not be greater than the main peak area of the control solution (0.5%).

residual solvents acetone, Tetrahydrofuran, methanol and ethanol

take an appropriate amount of this product, accurately weigh, add water to dissolve and quantitatively dilute to make a solution containing about 50mg per lml, as a test solution; Separately take acetone, Tetrahydrofuran, the appropriate amount of methanol and ethanol is precisely weighed and diluted with water to prepare a solution containing about 250ug of acetone, 8ug of tetrahydrofuran, 150ug of methanol and 250ug of ethanol per 1 ml, which is used as a reference solution. 5ml of each of the test solution and the reference solution were accurately measured, respectively placed in the headspace bottle and sealed. According to the determination method of residual solvent (General 0861 second method), a capillary column with 5% phenyl 95% dimethyl polysiloxane as stationary liquid was used; The initial temperature was 40 C, and the temperature was maintained for 7 minutes, the temperature was raised to 120°C at a rate of 8°C per minute for 5 minutes; The detector temperature was 250°C; The gasification chamber temperature was 200°C; The headspace bottle equilibrium temperature was 85°C for 30 minutes. Take the reference solution into the headspace, the separation degree between the peaks of each component shall meet the requirements. Then the sample solution and the reference solution were injected with headspace, and the chromatogram was recorded. According to the external standard method, the residual amount of acetone, Tetrahydrofuran, methanol and ethanol shall be calculated by the peak area.

N ,N-dimethylformamide

take an appropriate amount of this product, accurately weigh it, add water to dissolve and quantitatively dilute it to make a solution containing about 250mg per lml as a test solution; Take an appropriate amount of N, N-dimethylformamide, precision weighing, adding water to dissolve and quantitatively dilute to prepare a solution containing about 220ug of N, N-dimethylformamide per 1 ml as a reference solution. According to the determination method of residual solvent (General 0 861 third method), a capillary column with 5% phenyl 95% dimethyl polysiloxane as stationary liquid was used; The initial temperature was 60 C, and the time was maintained for 7 minutes, the temperature was raised to 120°C at a rate of 8°C per minute for 5 minutes; The detector temperature was 250°C; And the inlet temperature was 200°C. The lul of the test solution and the reference solution are accurately measured, respectively injected into the human gas chromatograph, the chromatogram is recorded, and the peak area is calculated according to the external standard method. The residual amount of N ,N-dimethylformamide should comply with the regulations.

moisture

take this product, according to the moisture determination method (General 0832 first method 1), containing water not more than 8.0%.

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 burning and flooding shall not contain more than 20 parts per million of heavy metals for examination by law (General rule 0821, Law II).

Last Update：2022-01-01 14:23:04

L-VALINE 2-[(2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9YL)METHOXY]ETHYL ESTER, HYDROCHLORIDE SALT - 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 as a filler; 0.Olmol/L potassium dihydrogen phosphate solution (adjusted to pH 3.0 with phosphoric acid)-methanol (85:15) as mobile phase; The detection wavelength was 251nm; The column temperature was 35°C. The acyclovir control solution (1 ml) and the Valacyclovir hydrochloride control solution (5ml) were mixed with each other and used as the applicable solution for the system, the resolution of valaciclovir peak and acyclovir peak should meet the requirements.

assay

take this product about 50mg, precision weighing, 100ml flask, plus O.Olmol /L potassium dihydrogen phosphate solution (pH 3.0) was dissolved and diluted to the scale, then shaken; The appropriate amount was accurately measured and diluted with mobile phase to prepare a solution containing about 50ug per 1 ml, as a test solution, 20ul was injected into the liquid chromatograph with precision, and the chromatogram was recorded. Another valaciclovir hydrochloride reference substance was determined by the same method. According to the external standard method to calculate the peak area, that is.

Last Update：2022-01-01 14:23:05

L-VALINE 2-[(2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9YL)METHOXY]ETHYL ESTER, HYDROCHLORIDE SALT - Category

Authoritative Data Verified Data

antiviral drugs.

Last Update：2022-01-01 14:23:05

L-VALINE 2-[(2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9YL)METHOXY]ETHYL ESTER, HYDROCHLORIDE SALT - Storage

Authoritative Data Verified Data

sealed and stored in a dry place.

Last Update：2022-01-01 14:23:05

L-VALINE 2-[(2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9YL)METHOXY]ETHYL ESTER, HYDROCHLORIDE SALT - Valaciclovir Hydrochloride Tablets

Authoritative Data Verified Data

This product contains valaciclovir hydrochloride (C13H20N604 • HCI) should be 90.0% ~ 110.0% of the label amount.

trait

This product is a film-coated tablet, white or off-white after removal of the coating.

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 control solution.

examination

  • Related substances the appropriate amount of fine powder under the content determination item (about 50mg equivalent to valacyclovir hydrochloride) was accurately weighed and placed in a 100ml measuring flask. 1 mol/L potassium dihydrogen phosphate solution (adjusted to pH 3.0 with phosphoric acid) to dissolve valacyclovir hydrochloride and dilute to the scale, shake, filter, and take the continued filtrate as a test solution. If there are impurity peaks in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and acyclovir shall not exceed 1.5% of the labeled amount of valacyclovir hydrochloride; the sum of the peak areas of other impurities shall not be greater than 2 times (1.0%) of the main peak area of the control solution.
  • dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.900ml of lmol /L hydrochloric acid solution is the dissolution medium, and the rotation speed is 50 revolutions per minute. The operation is carried out according to law. After 45 minutes, the appropriate amount of the solution is taken, filtered, and the appropriate amount of the filtrate is taken, the solution containing about 16ug of valacyclovir hydrochloride in 1 ml was prepared by quantitative dilution with dissolution medium, and then the absorbance was measured at the wavelength of 252nm by ultraviolet-visible spectrophotometry (General rule 0401); in addition, an appropriate amount of valaciclovir hydrochloride reference substance was accurately weighed, dissolved and quantitatively diluted with dissolution medium to prepare a solution containing about 16ug per lml, and the dissolution amount of each tablet was calculated by the same method. The limit is 85% 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 10 tablets of this product, precision weighing, fine grinding, precision weighing appropriate amount (about 50mg equivalent to valacyclovir hydrochloride), put it in a 100ml measuring flask, add O.Olmol/L potassium dihydrogen phosphate solution (adjusted to pH 3.0 with phosphoric acid) was dissolved and diluted to the scale, and then it was shaken, left standing, filtered, and then the appropriate amount of filtrate was taken, diluted with mobile phase to a solution containing about 50% per 1 ml, as a test solution, measured and calculated according to the method under valacyclovir hydrochloride.

category

with valaciclovir hydrochloride.

specification

(1)0.15g (2)0.3g (3)0.5g

storage

sealed and stored in a dry place.

Last Update：2022-01-01 14:23:06

L-VALINE 2-[(2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9YL)METHOXY]ETHYL ESTER, HYDROCHLORIDE SALT - Valaciclovir hydrochloride capsules

Authoritative Data Verified Data

This product contains valaciclovir hydrochloride (C13H20N604 • HCl) should be 90.0% ~ 110.0% of the label amount.

trait

The content of this product is white or white powder.

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 control solution.

examination

  • appropriate amount of contents (about 50mg of valacyclovir hydrochloride) under the item of difference in loading amount of related substances, A 0.01mol/L potassium dihydrogen phosphate solution (adjusted to pH 3.0 with phosphoric acid) was added to dissolve valacyclovir hydrochloride and dilute to the scale, shake well, filter, and take the continued filtrate as a test solution. If there are impurity peaks in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and acyclovir shall not exceed 1.5% of the labeled amount of valacyclovir hydrochloride; the sum of the peak areas of other impurities shall not be greater than 2 times (1.0%) of the main peak area of the control solution.
  • the dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method), water 900ml as the dissolution medium, the speed of 50 rpm, according to the law, after 45 minutes, take 10ml of the solution, filter, take the appropriate amount of the filtrate, quantitatively dilute with phosphate buffer (pH 7.0) to prepare a solution containing 16ug of valacyclovir hydrochloride in each lml, and shake well, UV-Vis spectrophotometry (General rule 0401), at the wavelength of 252nm were measured absorbance; Another valacyclovir hydrochloride reference standard amount, precision weighing, plus phosphate buffer (pH 7.0) dissolve and quantitatively dilute to prepare a solution containing about 16ug per 1 ml, and measure with the same method to calculate the amount of dissolution of each particle. The limit is 85% of the labeled amount and shall be in accordance with the provisions.
  • others should comply with the relevant provisions under the capsule (General 0103).

Content determination

take the contents under the item of difference in loading amount, mix them evenly, weigh an appropriate amount (about 50mg of valacyclovir hydrochloride) precisely, put it in a 100ml measuring flask, and add O.Olmol/L potassium dihydrogen phosphate solution (adjusted to pH 3.0 with phosphoric acid) was dissolved and diluted to the scale, and then it was shaken, left standing, filtered, and then the appropriate amount of filtrate was taken, diluted with mobile phase to a solution containing about 50ug per 1 ml, as a test solution, measured and calculated according to the method under the item valacyclovir hydrochloride.

category

with valaciclovir hydrochloride.

specification

0.15g

storage

sealed and stored in a dry place.

Last Update：2022-01-01 14:23:07
L-VALINE 2-[(2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9YL)METHOXY]ETHYL ESTER, HYDROCHLORIDE SALT
Supplier List
Guangzhou Yuanda New Material Co.,Ltd
Product Name: Valacyclovir hydrochloride Request for quotation
CAS: 124832-27-5
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Product Name: Valaciclovir HCl Request for quotation
CAS: 124832-27-5
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Shanghai Yuanye Bio-Technology Co., Ltd.
Multiple SpecificationsSpot supply
Product Name: Valacyclovir hydrochloride Visit Supplier Webpage Request for quotation
CAS: 124832-27-5
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409 Click to send a QQ message
Wechat: 18301782025
Guangzhou Yuanda New Material Co.,Ltd
Product Name: Valacyclovir hydrochloride Request for quotation
CAS: 124832-27-5
Tel: +86 19849939632
Email: 2470479589@qq.com
Mobile: +86 19849939632
QQ: 2470479589 Click to send a QQ message
Wechat: +86 19849939632
Hefei TNJ Chemical Industry Co.,Ltd.
Product Name: Valaciclovir HCl Request for quotation
CAS: 124832-27-5
Tel: 0086-551-65418684
Email: sales@tnjchem.com
　　　　 info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840 Click to send a QQ message
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: Valacyclovir hydrochloride Visit Supplier Webpage Request for quotation
CAS: 124832-27-5
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409 Click to send a QQ message
Wechat: 18301782025
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L-VALINE 2-[(2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9YL)METHOXY]ETHYL ESTER, HYDROCHLORIDE SALT
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