Famciclovir
Famciclovir
CAS: 104227-87-4
Molecular Formula: C14H19N5O4
Famciclovir - Names and Identifiers
| Name | Famciclovir |
| Synonyms | Amciclovir famcyclovir Famciclover FAMCICLOVIR Famciclovir [2-(acetyloxymethyl)-4-(2-aminopurin-9-yl)-butyl] acetate [2-(acetyloxymethyl)-4-(2-aminopurin-9-yl)butyl] ethanoate 2-[(acetyloxy)methyl]-4-(2-amino-9H-purin-9-yl)butyl acetate 2-[2-(2-AMINO-9H-PURIN-9-YL)ETHYL]-1,3-PROPANEDIOL, DIACETATE ESTER |
| CAS | 104227-87-4 |
| EINECS | 630-411-6 |
| InChI | InChI=1/C14H19N5O4/c1-9(20)22-6-11(7-23-10(2)21)3-4-19-8-17-12-5-16-14(15)18-13(12)19/h5,8,11H,3-4,6-7H2,1-2H3,(H2,15,16,18) |
| InChIKey | GGXKWVWZWMLJEH-UHFFFAOYSA-N |
Famciclovir - Physico-chemical Properties
| Molecular Formula | C14H19N5O4 |
| Molar Mass | 321.33 |
| Density | 1.40±0.1 g/cm3(Predicted) |
| Melting Point | 102-104°C |
| Boling Point | 550.2±60.0 °C(Predicted) |
| Flash Point | 286.6°C |
| Solubility | DMSO 64 mg/mL (199.16 mM);Water 64 mg/mL (199.16 mM);Ethanol 48 mg/mL (149.37 mM). |
| Vapor Presure | 3.73E-12mmHg at 25°C |
| Appearance | grayish white powder |
| Color | White to Off-White |
| Maximum wavelength(λmax) | ['310nm(EtOH)(lit.)'] |
| pKa | 4.00±0.10(Predicted) |
| Storage Condition | 2-8°C |
| Refractive Index | 1.628 |
| MDL | MFCD00866964 |
| Physical and Chemical Properties | White crystals |
| Use | Antiviral drugs for the treatment of herpes zoster and genital blisters |
Famciclovir - Risk and Safety
| Hazard Symbols | T - Toxic |
| Risk Codes | R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. R45 - May cause cancer R61 - May cause harm to the unborn child |
| Safety Description | 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.) S53 - Avoid exposure - obtain special instructions before use. S24/25 - Avoid contact with skin and eyes. |
| WGK Germany | 3 |
| RTECS | TY3164000 |
| HS Code | 29335990 |
Famciclovir - Reference
| Reference Show more | 1. [IF=3.535] Hui Jiang et al."Determination of lipid–water partition coefficient of neutral and ionic drugs by liposome electrokinetic chromatography."Electrophoresis. 2021 Aug;42(14-15):1436-1449 2. [IF=3.935] Hui Jiang et al."Preparation of covalently bonded liposome capillary column and its application in evaluation of drug membrane permeability."J Pharmaceut Biomed. 2022 Feb;209:114513 |
Famciclovir - Nature
Open Data Verified Data
A white lustrous Flake crystal having a melting point of 102 to 104 ° C. Was obtained from ethyl acetate-hexane. UV maximum absorption (methanol):222nm, 244nm,309r Ⅱ n (e27500,4800,7160). Solubility in water (25 ° C.): Initial> 25% (Volume), the formation of monohydrate precipitates quickly [2%~ 3%(volume)]. Soluble in acetone or methanol, difficult to dissolve in ethanol or isopropanol. Calculated as dry product, containing C14 H19 Ns 04 shall not be less than 98.5% J ph value should be 6.0~7.5 'related substances should be in accordance with the provisions; Loss of drying, drying under reduced pressure at 80 ℃ to constant weight, loss of weight shall not exceed 0.5%; Ignition residue, residue shall not exceed 0.1% l of heavy metals, containing heavy metals must not pass 0. 002%.
Last Update：2025-06-10 22:55:16
Famciclovir - Preparation Method
Open Data Verified Data
2-amino -6-chloropurine was dissolved in water containing sodium hydroxide, and hydrogenated at a certain temperature and pressure in the presence of palladium-carbon to obtain 2-amino purine. The 2-amino purine, 2-(2-iodine ethyl) propylene glycol Diethyl ester and potassium carbonate in Dimethyl Formamide reaction to famciclovir. Alternatively, 8 chloroguanine is obtained from the reaction of guanine, triethylmethylammonium chloride and sulfoxide chloride. The 8 monochloroguanine was converted to the hydrochloride salt and dried in the presence of phosphorus pentachloride. A solution of triethylmethylammonium chloride in acetonitrile was added to the hydrochloride salt, and phosphorus oxychloride was added to obtain 2-amino -6,8-= chloropurine. This material is reacted with 2-(2-iodoethyl) propylene glycol diacetate, potassium carbonate in dimethylformamide, and the resulting compound is reduced by hydrogenation in the presence of palladium on carbon to give famciclovir.
Last Update：2025-06-10 22:55:16
Famciclovir - Standard
Authoritative Data Verified Data
This product is 2-[2-[9-(2-amino-9h-purinyl)] ethyl]-1, 3-propanediol diacetate. Calculated as dried product, including C14H19N504 shall not be less than 98.5%.
Last Update：2024-01-02 23:10:35
Famciclovir - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Odorless.
- This product is soluble in water, methanol, ethanol or dichloromethane, slightly soluble in ethyl acetate, almost insoluble in ether.
melting point
The melting point of this product (General 0612) is 102~104°C.
absorption coefficient
take this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing about 20ug per lml, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 305nm, and the absorption coefficient was 205 to 220.
Last Update：2022-01-01 11:59:16
Famciclovir - Application
Open Data Verified Data
developed by Beecham, UK, was first launched in the UK in 1994. Antiviral drugs. For the treatment of acute herpes zoster. Famciclovir is Penciclovir (Penciclovir) of 6 deoxy derivatives of two ethyl ester, high bioavailability, can be used instead of Penciclovir.
Last Update：2025-08-19 16:24:40
Famciclovir - Differential diagnosis
Authoritative Data Verified Data
- take an appropriate amount of this product, add water to dissolve and dilute to make a solution containing about 10ug per lml, and measure by UV-Vis spectrophotometry (General rule 0401) at 221nm, there is a maximum absorption at the wavelength of 243nm and 305nm.
- 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 956).
Last Update：2022-01-01 11:59:17
Famciclovir - Exam
Authoritative Data Verified Data
pH
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 6.0~7.5.
Related substances
take this product, add mobile phase to dissolve and dilute to make a solution containing about 0.2mg per lml as a test solution; Take lml for precision measurement and put it in a 200ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. Except that the detection wavelength is adjusted to 221mn, under other chromatographic conditions under the content determination item, 20 u1 of the test solution and 20 u1 of the control solution are accurately measured and injected into the human liquid chromatograph respectively, the chromatogram was recorded to 2.5 times the retention time of the main peak. If there are impurity peaks in the chromatogram of the test solution, the area of each single impurity peak shall not be greater than the area of the main peak of the control solution (0.5% ) , the sum of each impurity peak area shall not be greater than 2 times (1.0%) of the main peak area of the control solution.
residual solvent
take about 0.25g of this product, weigh it accurately, place it in the top empty bottle, add 5ml of water accurately to dissolve it, seal it, and use it as a test solution; Take methanol, the appropriate amount of ethyl acetate and methane is precisely weighed and quantitatively diluted with water to make a mixed solution containing about 0.15mg of methyl alcohol, 0.25mg of ethyl acetate and 0.03mg of dichloromethane per 1 ml, and the precise amount is 5ml, top empty bottle, sealed, as a control solution. According to the determination method of residual solvent (General Principle 0861 first method), the capillary column with 5% phenylmethylsiloxane as stationary liquid is used as the column; The column temperature is 50°C; The inlet temperature is 200°C; the detector temperature was 250°C; The headspace bottle equilibration temperature was 85°C and the equilibration time was 30 minutes. Take the reference solution into the headspace, the separation degree between the chromatographic peaks should 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 methanol, ethyl acetate and dichloromethane shall be calculated by the peak area.
loss on drying
take this product, at 80°C under reduced pressure drying to constant weight, weight loss should 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 11:59:17
Famciclovir - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
The mobile phase was acetonitrile -0.02mol/L potassium dihydrogen phosphate solution (20:80). The detection wavelength was 305nm. The number of theoretical plates is not less than 2500 calculated from the peak of famciclovir.assay
take an appropriate amount of this product, accurately weigh it, add the mobile phase to dissolve and quantitatively dilute to prepare a solution containing about 1 ml per 1 ml, as a test solution, and inject 20u1 into the liquid chromatograph with a precise amount, record the chromatogram; Take another famciclovir reference substance, the same method for determination, according to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 11:59:18
Famciclovir - Category
Authoritative Data Verified Data
antiviral drugs.
Last Update：2022-01-01 11:59:18
Famciclovir - Storage
Authoritative Data Verified Data
sealed and stored in a dry place.
Last Update：2022-01-01 11:59:18
Famciclovir - Famciclovir Tablets
Authoritative Data Verified Data
This product contains famciclovir (C14H19N504) should be labeled the amount of 90.0% to 110.0%.
trait
This product is a white to off-white tablet or film-coated tablet that appears white to off-white after removal of the coating.
identification
- take this product, grind (film-coated tablets to remove coating), take appropriate amount of fine powder, add water to shake to dissolve famciclovir and dilute to make a solution containing about 10ug of famciclovir per 1 ml, filter, the filtrate was taken and had absorption maxima at the wavelengths of 221nm, 243nm and 305nm as determined by UV-Vis spectrophotometry (pass 0401).
- 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
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method), with water as the dissolution medium, the speed is 100 rpm, according to the law, after 30 minutes, take 10ml of the solution, filter, take the appropriate amount of the filtrate, and dilute it quantitatively with water to make a solution containing about 25ug per lml, as a test solution, according to UV-visible spectrophotometry (General rule 0401), determine absorbance at the wavelength of 305nm; Take appropriate amount of famciclovir reference substance, water was added to dissolve and quantitatively diluted to prepare a solution containing about 25ug per 1 ml, which was determined by the same method, and the dissolution amount of each tablet was calculated. 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
Take 20 tablets of this product, precision weighing, fine grinding, precision weighing appropriate amount (about equivalent to famciclovir lOOmg), add mobile phase to dissolve famciclovir and dilute quantitatively to prepare a solution containing about 50ug of famciclovir per 1 ml, shake well, filter, and take the continued filtrate as the test solution, according to the method under famciclovir determination, calculation, that is obtained.
category
Same as famciclovir.
specification
(1)0.125g (2)0.25g
storage
sealed storage.
Last Update：2022-01-01 11:59:19
Famciclovir - Famciclovir Capsules
Authoritative Data Verified Data
This product contains famciclovir (C14H19N504) should be 90.0% to 110.0% of the label.
trait
The content of this product is white or white powder.
identification
- take an appropriate amount of the contents of this product, add water to shake to dissolve famciclovir and dilute it to make a solution containing about 10% of famciclovir per 1 ml, filter it, and take the filtrate, the absorption maxima were determined by UV-Vis spectrophotometry (General 0401) at the wavelengths of 221nm, 243nm and 305nm.
- 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
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method), with water as the dissolution medium, the speed is 100 rpm, according to the law, after 30 minutes, take 10ml of the solution, filter, take the appropriate amount of the filtrate, and dilute it quantitatively with water to make a solution containing about 25ug per lml, as a test solution, according to UV-visible spectrophotometry (General rule 0401), determine absorbance at the wavelength of 305nm; Take appropriate amount of famciclovir reference substance, water was added to dissolve and quantitatively diluted to prepare a solution containing about 25ug per 1 ml, which was determined by the same method, and the dissolution amount of each particle was calculated. The limit is 80% 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 loading amount difference, mix them evenly, weigh appropriately (about 100mg equivalent to famciclovir), add mobile phase to dissolve famciclovir and dilute quantitatively to prepare a solution containing about 50ug of famciclovir per 1 ml, shake well, filter, and take the continued filtrate as the test solution, according to the method under the item famciclovir determination, count, obtained.
category
Same as famciclovir.
specification
0.125g
storage
sealed storage.
Last Update：2022-01-01 11:59:20
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