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GVC

Ganciclovir

CAS: 82410-32-0

Molecular Formula: C9H13N5O4

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GVC - Names and Identifiers

Name Ganciclovir
Synonyms GVC
2'-NDG
Denosine
Cytovene
Ganciclovir
GANCICILOVIR
2'-Nor-2'-deoxyguanosine
9-(1,3-Dihydroxy-2-propoxymethyl)guanine
9-((2-Hydroxy-1-(hydroxymethyl)ethoxy)-methyl)guanine
GANCICLOVIR [9-(1,3-DIHYDROXY-2-PROPOXYMETHYL)GUANINE]
2-AMINO-9-((1,3-DIHYDROXYPROPAN-2-YLOXY)METHYL)-1H-PURIN-6(9H)-ONE
2-AMINO-1,9-[[2-HYDROXY-1-(HYDROXYMETHYL)ETHOXY]METHYL]6H-PURIN-6-ONE
2-Amino-1,9-dihydro-9-((2-hydroxy-1-(hydroxymethyl)ethoxy)methyl)-6H-purin-6-one
2-AMINO-1,9-[[2-HYDROXY-1-(HYDROXYMETHYL)ETHOXY]METHYL]6H-PURIN-6-ONE(GANCICLOVIR)
CAS 82410-32-0
EINECS 627-054-3
InChI InChI=1/C9H13N5O4/c10-9-12-7-6(8(17)13-9)11-3-14(7)4-18-5(1-15)2-16/h3,5,15-16H,1-2,4H2,(H3,10,12,13,17)
InChIKey IRSCQMHQWWYFCW-UHFFFAOYSA-N

GVC - Physico-chemical Properties

Molecular FormulaC9H13N5O4
Molar Mass255.23
Density1.3559 (rough estimate)
Melting Point250°C
Boling Point398.46°C (rough estimate)
Flash Point9℃
Water Solubility3.6g/L(25 ºC)
Solubility 0.1M HCl
AppearanceWhite powder
Colorwhite
Merck14,4363
pKa9.33±0.20(Predicted)
Storage Condition2-8°C
Refractive Index1.7610 (estimate)
MDLMFCD00870588
Physical and Chemical PropertiesCrystallization from methanol, melting point 250 ℃ (decomposition); There are also reports of monohydrate obtained from water, melting point 248-249 ℃ (decomposition); Crystallization from water, melting point> 300 °c UV maximum absorption (methanol):254nm (Φ12880). Solubility in water at 25 ° C.: 4.3mg/Ml at Ph = 7 Acute toxicity LD50 mice (g/kg):1~2 intraperitoneal injection.
UseAnti-Virus, for the treatment of Cytomegalovirus Virus (CMV) infections due to immunocompromised

GVC - Risk and Safety

Hazard SymbolsT - Toxic
Toxic
Risk CodesR46 - May cause heritable genetic damage
R60 - May impair fertility
R61 - May cause harm to the unborn child
Safety DescriptionS53 - Avoid exposure - obtain special instructions before use.
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 IDsUN1230 - class 3 - PG 2 - Methanol, solution
WGK Germany3
RTECSMF8407000
HS Code29335990
ToxicityLD50 i.p. in mice: 1-2 g/kg (Martin)

GVC - Standard

Authoritative Data Verified Data

This product is 9-[[2-hydroxy-l-(hydroxymethyl) ethoxy] methyl] guanine. The content of C9H13N504 shall not be less than 99.0% calculated as dry product.

Last Update：2024-01-02 23:10:35

GVC - Trait

Authoritative Data Verified Data
  • This product is a white crystalline powder; Odorless; Has hygroscopicity.
  • This product is slightly soluble in water or glacial acetic acid, almost insoluble in methanol, insoluble in methane; Slightly soluble in hydrochloric acid solution or sodium hydroxide solution.
Last Update：2022-01-01 11:56:17

GVC - Differential diagnosis

Authoritative Data Verified Data
  1. take an appropriate amount of this product, add water 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 a wavelength of 252MN; There is a minimum absorption at a wavelength of 222nm.
  2. The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1266). If there is any difference, take an appropriate amount of this product and the reference product, add water separately to make saturated solution, filter, take the filtrate below 10°C overnight, wait for crystallization, filter, filter, filter residue after drying at 105°C, assay again.
Last Update：2022-01-01 11:56:17

GVC - Exam

Authoritative Data Verified Data

Related substances

Take 15mg of this product, put it in a 50ml measuring flask, add 1ml of 0.4% sodium hydroxide solution to dissolve it, dilute it with mobile phase to scale, shake well, and use it as a test solution. Take 1ml for precision measurement, set in a 100ml measuring flask, dilute to the scale with the mobile phase, and shake to serve as a control solution. According to high performance liquid chromatography (General rule 0512), silica gel bonded with eighteen alkyl silane was used as filler; Methanol-water (5:95) was used as mobile phase; Detection wavelength was 252nm; the number of theoretical plates is not less than 3000 according to the ganciclovir peak. 20ul of the test solution and the control solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded 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 (1.0%).

loss on drying

take this product, dry to constant weight at 105°C, weight loss shall not exceed 6.0% (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 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).

Last Update：2022-01-01 11:56:18

GVC - Content determination

Authoritative Data Verified Data

take this product about 0.15g, precision weighing, add glacial acetic acid 40ml, heat to dissolve, cool, add crystal violet indicator solution 1 drop, with perchloric acid titration solution (O. 1 mol/L) titration to the solution is green, and the result of the titration is corrected with a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 25.52mg of C9H13N5O4.

Last Update：2022-01-01 11:56:18

GVC - Category

Authoritative Data Verified Data

antiviral drugs.

Last Update：2022-01-01 11:56:18

GVC - Storage

Authoritative Data Verified Data

light shielding, sealed storage.

Last Update：2022-01-01 11:56:18

GVC - Ganciclovir and sodium chloride injection

Authoritative Data Verified Data

This product is a sterilized aqueous solution of ganciclovir and sodium chloride. Ganciclovir-containing (C0H13N5O4) shall be 90.0% to 110.0% of label and sodium chloride (NaCl)-containing shall be 95.0% to 105.0% of label.

trait

This product is colorless and clear liquid.

identification

  1. take an appropriate amount of this product (about equivalent to ganciclovir 20mg), put it on a water bath to evaporate, let it cool, add hydrochloric acid lml and potassium chlorate O.lg, the residue was evaporated to dryness on a water bath, and a few drops of ammonia test solution were added to the residue to show purplish red color; A few drops of sodium hydroxide test solution were added, and the purplish red color disappeared.
  2. 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 ganciclovir control solution.
  3. This product sodium salt identification (1) reaction and chloride identification (1) reaction (General rule 0301).

examination

  • the pH value should be 7.0 to 9.0 (General 0631).
  • Related substances a solution containing about 0.3mg of ganciclovir per 1 ml was prepared by diluting the product with the mobile phase, which was used as a test solution for determination according to the method for ganciclovir related substances. Except for the sodium chloride 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%).
  • take 50ml of heavy metal, evaporate to about 20ml on a water bath, let it cool, add 2ml of acetate buffer (pH 3.5) and appropriate amount of water to make 25ml, inspection according to law (General Principles 0821, Law 1), containing heavy metals must not exceed three million. The osmolality should be 270 to 310 mosmol/kg (General 0632).
  • bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per lml should be less than 0.50EU.
  • others should comply with the relevant provisions under injection (General 0102).

Content determination

  • ganciclovir was measured by high performance liquid chromatography (General 0512).
  • chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-water (5:95) as mobile phase; The detection wavelength was 252nm. The number of theoretical plates is not less than 3000 according to the ganciclovir peak.
  • determination precision: take an appropriate amount of this product and quantitatively dilute it with mobile phase to prepare a solution containing 40ug of ganciclovir per 1 ml as a test solution; Take about 25mg of ganciclovir reference substance, put it in a 25ml measuring flask, add 1 ml of 0.4% sodium hydroxide solution to dissolve it, dilute it to the scale with mobile phase, shake it, take an appropriate amount with precision, and dilute it with mobile phase to make a solution containing 40ug per 1 ml, as a control solution. 20 u1 of the test solution and the reference solution were respectively injected into the liquid chromatograph, and the chromatograms were recorded. According to the external standard method to calculate the peak area, that is.
  • sodium nitride precision measure 10ml of this product, add 40ml of water, 5ml of 2% dextrin solution, and 0.lg and fluorescent yellow indicator solution 5~8 drops, with silver nitrate titration solution (0.lmol/L) titration, each lm l silver nitrate titration solution (0.1 mol/L) corresponds to 5.844mg of NaCl.

category

Same as ganciclovir.

specification

  1. 100ml: 0.05g ganciclovir and 0.9g sodium chloride
  2. 100ml: ganciclovir 0.lg with sodium chloride 0.9g
  3. 250ml: ganciclovir 0.25g with sodium chloride 2.25g

storage

sealed storage.

Last Update：2022-01-01 11:56:19

GVC - Ganciclovir for injection

Authoritative Data Verified Data

This product is ganciclovir plus the right amount of sodium hydroxide solution, by freeze-drying of sterile products. Based on the average loading, ganciclovir (C9H13N5O4) should be 90.0%-110.0% of the standard water content.

trait

This product is a white loose block or powder; There is moisture.

identification

  1. take an appropriate amount of this product (about 20mg of ganciclovir), add 2ml of hydrochloric acid, put it on a water bath to evaporate, add lml of hydrochloric acid and about 30mg of potassium chlorate, put it on a water bath to evaporate dry, A few drops of ammonia test solution were added to the residue, and then several drops of sodium hydroxide test solution were added. The purple color disappeared. If there is interference, take the white precipitate under identification (3) and test again.
  2. 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.
  3. take an appropriate amount of this product, add water to dissolve, adjust to Neutral with dilute hydrochloric acid or ammonia test solution, that is, generate white precipitate, filter, filtrate sodium salt identification (1) reaction (General 0301).

examination

  • alkalinity this product is dissolved in water and diluted to prepare a solution containing 12.5mg of ganciclovir per 1 ml, which is measured according to law (General rule 0631). The pH value should be 10.5~11.5.
  • clarity of solution take this product, add water to dissolve and dilute into ganciclovir lOmg solution per 1 ml, the solution should be clear, if it is turbid, compared with No. 1 turbidity standard solution (General Principles 0902 first method), should not be more concentrated.
  • Related substances the product was taken, dissolved by adding mobile phase and diluted to give a solution containing about 0.3mg of ganciclovir per 1 ml, which was used as a test solution and measured according to the method under ganciclovir related substances. 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 area of the main peak of the control solution (1.0%).
  • the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 6.0%, first method 1).
  • bacterial endotoxin this product, according to the law inspection (General 1143), per 1 mg ganciclovir containing endotoxin should be less than 0.50EU.
  • sterile take this product, add 0.9% sterile sodium chloride solution to dissolve the appropriate amount, after the membrane filtration method, according to the law (General 1101), should comply with the provisions.
  • others should be in accordance with the relevant provisions under injection (General rule 0l02).

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; Methanol-water (5:95) as mobile phase; The detection wavelength was 252mn. The number of theoretical plates is not less than 3000 according to the ganciclovir peak.
  • 5 pieces of this product were measured, and the contents of each container were accurately weighed, and the contents of each container were dissolved with mobile phase, and then the whole amount was transferred to the same measuring flask and mixed well, take appropriate amount with precision and dilute quantitatively with mobile phase to make a solution containing 40ug of ganciclovir per 1 ml as a test solution. Take 25mg of ganciclovir as the control substance and place it in a 25ml measuring flask, add 0.4% sodium hydroxide solution lm l to dissolve, dilute to scale with mobile phase, shake well, take appropriate amount with precision, and quantitatively dilute with mobile phase to prepare a solution containing about 40ug per 1 ml as a reference solution. 20 u1 of the test solution and the reference solution were respectively injected into the human liquid chromatograph, and the chromatograms were recorded. According to the external standard method to calculate the peak area, that is.

category

Same as ganciclovir.

specification

(1)0.05g (2)0.15g (3)0.25g (4)0.5g

storage

light shielding, closed storage.

Last Update：2022-01-01 11:56:20
GVC
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Hubei YoungXin Pharmaceutical Tech Co.,Ltd.
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CAS: 82410-32-0
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CAS: 82410-32-0
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CAS: 82410-32-0
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Shanghai Yuanye Bio-Technology Co., Ltd.
Multiple SpecificationsSpot supply
Product Name: Ganciclovir Visit Supplier Webpage Request for quotation
CAS: 82410-32-0
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409 Click to send a QQ message
Wechat: 18301782025
Hubei YoungXin Pharmaceutical Tech Co.,Ltd.
Spot supply
Product Name: Ganciclovir Visit Supplier Webpage Request for quotation
CAS: 82410-32-0
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052 Click to send a QQ message
Wechat: 15671228036
Guangzhou Yuanda New Material Co.,Ltd
Product Name: Ganciclovir Request for quotation
CAS: 82410-32-0
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: Ganciclovir Request for quotation
CAS: 82410-32-0
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: Ganciclovir Visit Supplier Webpage Request for quotation
CAS: 82410-32-0
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409 Click to send a QQ message
Wechat: 18301782025
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GVC
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