2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Names and Identifiers

Name	acycloguanosine
Synonyms	Zoviax aciclovir acielovir Acyclovir cycloguanosine acycloguanosine aciclovirum(latin) Acyclovir (Patented-No Supply) 9-[(2-Hydroxyethoxy)methyl]guanine N(9)-Oxyethoxymethylguanine (Acyclovir) 2-AMINO-9-(2-HYDROXY-ETHOXYMETHYL)-1,9-DIHYDRO-PURIN-6-ONE 1,9-dihydro-2-amino-9-((2-hydroxyethoxy)methyl)-6h-purin-6-on 2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one 2-amino-1,9-dihydro-9-((2-hydroxyethoxy)-methyl)-6h-purin-6-on
CAS	59277-89-3
EINECS	261-685-1
InChI	InChI=1/C8H11N5O3/c9-8-11-6-5(7(15)12-8)10-3-13(6)4-16-2-1-14/h3,14H,1-2,4H2,(H3,9,11,12,15)
InChIKey	MKUXAQIIEYXACX-UHFFFAOYSA-N

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Physico-chemical Properties

Molecular Formula	C8H11N5O3
Molar Mass	225.2
Density	1.3654 (rough estimate)
Melting Point	256-257°C
Boling Point	366.71°C (rough estimate)
Water Solubility	Soluble in 1M HCl at 50mg/ml. Soluble in water at 0.7mg/ml. Also soluble in DMSO
Solubility	H2O: 0.7 mg/mL
Appearance	White solid
Color	white
Merck	14,146
pKa	pKa 2.27 (Uncertain);9.25 (Uncertain)
Storage Condition	2-8°C
Stability	Stable. Incompatible with strong oxidizing agents.
Refractive Index	1.8000 (estimate)
MDL	MFCD00057880
Physical and Chemical Properties	White crystalline powder. Odorless and tasteless, its sodium salt is soluble in water
Use	The product is a purine nucleoside derivatives, the synthesis of DNA inhibition, the anti-herpes Virus activity 160 times stronger than vidarabine. Clinical for herpes simplex Virus encephalitis, herpes Virus keratitis and genital infection, AIDS varicella zoster Virus infection and giant cell Virus infection, chronic hepatitis B and so on.

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Risk and Safety

Risk Codes	R36/37/38 - Irritating to eyes, respiratory system and skin. R40 - Limited evidence of a carcinogenic effect R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed.
Safety Description	S22 - Do not breathe dust. S24/25 - Avoid contact with skin and eyes. S36 - Wear suitable protective clothing. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S23 - Do not breathe vapour.
WGK Germany	2
RTECS	UP0791400
HS Code	29335990
Hazard Class	IRRITANT
Toxicity	LD50 in mice (mg/kg): >10,000 orally; 1000 i.p. (Schaeffer)

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Reference

Reference

1. An Qiong, Yang Jianxia, Zhao xiui et al. Optimization of cloud point extraction combined with HILIC for determination of four anti-AIDS drugs in rat serum by response surface methodology [J]. Journal of Sun Yat-sen University (Medical Sciences) 2020 041(001):P.149-160.
2. Jie Liu. Effect of MiR-B10-3p on reactivation of latent infection in vitro of bovine herpes Virus 5 [J]. Huazhong Agricultural University, 2020.
3. Qian Su et al. [IF = 9.229]. "Promoting Room Temperature radiation through Electron Transfer from Carbon Dots to Promethazine. Acs Appl Mater Inter. 2021;13(34):41238-41248
4. [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
5. [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

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Nature

Open Data Verified Data

This product is white crystalline powder; Odorless, tasteless. Slightly soluble in glacial acetic acid or hot water, slightly soluble in cold water, very slightly soluble in ethanol, almost insoluble in ether or chloroform, soluble in dilute alkaline solution, soluble in dilute hydrochloric acid, also soluble in ammonia solution and dimethyl sulfoxide.
This product is a new anti-Virus drug containing purine nucleus, which is the strongest anti-herpes Virus drug so far, and its efficacy is 160 times stronger than vidarabine and 10 times stronger than Iodo. The strongest effect on type Herpes Sinplex Virus and type II; Varicella zoster virus, EB virus, African lymphatic virus is also effective, effective on Cytomegalovirus but resistant strains. In addition, it has a certain effect on hepatitis B Virus, and is ineffective against the mutant of non-thymidine kinase of herpes simplex and EB Virus (latent infection) in the non-replicating phase and the vast majority of RNA Virus. It has no anti-Virus activity, and is preferentially absorbed by the cells infected with herpes Virus after entering the body, and is converted into a triphosphate compound in the infected cells, which has a selective inhibitory effect on Virus DNA polymerase, and can be incorporated into Virus of the DNA strand being extended, thereby inhibiting Virus of DNA synthesis or stopping DNA extension. The effect on normal cells is small, so the toxicity is low, has a high therapeutic index, and the antiviral effect is 160 times stronger than that of cytarabine.

Last Update：2024-01-02 23:10:35

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Preparation Method

Open Data Verified Data

with guanine as raw material. Guanine and acetic anhydride were mixed, a small amount of acetic acid and zinc acetate were added, and the mixture was refluxed with stirring. The amount of acetic anhydride was distilled under reduced pressure, cooled to 0 ° C. And filtered. The filter cake was washed with ethanol and water, and dried to obtain N,N'-= acetyl guanine. Acetic anhydride, acetic acid and p-toluenesulfonic acid were mixed and cooled to below 10 °c. Dioxane was added with stirring, and the temperature was controlled below 40 °c. After cooling to room temperature, toluene and n. N '-= acetyl guanine were added and stirred to reflux. Chloroform was added and filtered. The filter cake was washed with chloroform, dried and dissolved in a 40% aqueous solution of methylamine, and stirred for reflux. After cooling, filtration, the filtrate was concentrated under reduced pressure to a slurry, which was washed with ethanol and filtered. The filter cake was recrystallized with water to obtain acyclovir. Or guanine trimethylsilylation, and then 2 a benzyloxy ethoxy methyl chloride reaction, and then remove the benzyl acyclovir.

Last Update：2022-01-01 09:08:03

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Standard

Authoritative Data Verified Data

This product is 9-(2-hydroxyethoxymethyl) guanine. Calculated as dried product, containing no less than 98.0% of C8H11N503.

Last Update：2024-01-02 23:10:35

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Trait

Authoritative Data Verified Data

This product is white crystalline powder; Odorless.
This product is slightly soluble in glacial acetic acid or hot water, almost insoluble in ether or dichloromethane; Soluble in sodium hydroxide solution.

Last Update：2022-01-01 12:00:08

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Introduction

Acyclovir is a synthetic nucleoside analog that acts effectively on herpes virus.

Last Update：2022-10-16 17:26:45

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Use

Open Data Verified Data

applicable to Herpes Sinplex Virus of patients with impaired immune function mucosa and skin or recurrence. Varicella, herpes zoster infection, herpes zoster and genital herpes, herpes simplex encephalitis in immunocompetent patients. Also used to prevent severe immune-compromised herpes simplex infection.
usage and dose of intravenous drip, herpes zoster in adults with herpes simplex (except herpes encephalitis), normal immune function and normal renal function: the dosage is 5 mg/kg, once every 8 hours; varicella zoster and herpes encephalitis with normal immunity and renal function: 10 mg/kg every time, once every 8 hours; For patients with acute and chronic renal insufficiency, the dose should be adjusted as follows.

Last Update：2022-01-01 09:08:04

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Differential diagnosis

Authoritative Data Verified Data

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 213).

Last Update：2022-01-01 12:00:09

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Safety

Open Data Verified Data

occasionally blood urea nitrogen and creatinine increased, reversible nerve reaction such as hallucination, tremor, Coma, etc. Some people Nausea, Vomit and other gastrointestinal reactions. Inflammation, necrosis, or phlebitis at the injection site is common. It is not applicable to those who are allergic to this product. Renal dysfunction, pregnant women, lactating women with caution. Intravenous infusion should be slow. Infusion must enter the right amount of water, in order to avoid the accumulation of acyclovir crystals in the renal tubules and affect renal function. Probenecid can increase the half-life and the area under the plasma concentration curve of systemic use of this product; Diluted liquid should not be stored before use.
light-shielding, closed, and stored in a dry place.

Last Update：2022-01-01 09:08:05

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Exam

Authoritative Data Verified Data

clarity and color of solution

take 0.50g of this product and add 0902 of 1% sodium hydroxide solution to dissolve the solution. The solution should be clear and colorless, not more concentrated (for injection) or compared with No. 2 Turbidity standard liquid (General 0902 first method), not more concentrated (for oral, external use such as color, no deeper comparison with yellow No. 1 Standard Colorimetric solution (General rule 0901 method 1) or comparison with yellow No. 2 Standard Colorimetric solution (General rule 0901 method 1), not deeper (for oral, external use).

Related substances

This product is dissolved and diluted with dimethyl sulfoxide to prepare a solution containing 10 mg per 1 ml. According to the thin layer chromatography (General 0502) test, 5ul of the above solution is absorbed, on the silica gel GF254 thin layer plate, using three gas methane-methanol-concentrated ammonia solution (80:20:2) as the developing solvent, expand, take out, dry, and set the UV lamp (254nm) to view, in addition to the main spot, no other impurity spots.

Bird Midge and other related substances

accurately weigh about 40mg of this product, put it in a 0.4% measuring flask, add 2ml of 0.1% sodium hydroxide solution to dissolve, add 25ml of (VV) phosphoric acid solution, and dilute it with water to the scale, shake well, as a test solution; Take 1ml of precision, put in a 0.1% measuring flask, add 5ml of phosphoric acid solution, dilute with water to the scale, shake well, as a control solution; in addition, take 10 mg of guanine reference product, put it in a 50ml measuring flask, add 5ml of 0.4% sodium hydroxide solution to dissolve it, and add 5ml of 0.1% phosphoric acid solution, dilute it to the mark with water, and shake it well, as a guanine control stock solution; Take 1ml of precision, put in a 100ml measuring flask, dilute to the scale with water, shake, as a guanine impurity control solution. According to the determination of high performance liquid chromatography (General 0512), with eighteen alkyl silane bonded silica gel as filler; Water as mobile phase A, Methanol was used as mobile Phase B, and the gradient elution was carried out according to the following table; The column temperature was 35 ° C.; The detection wavelength was 254nm. The appropriate amount of guanine reference solution and control solution was mixed in equal volume, then it was shaken, and 20u1 was injected into the liquid chromatograph to adjust the chromatographic system. The resolution between acyclovir peak and guanine peak should be greater than 3.0. The sample solution, guanine reference solution and control solution of 20 u1 were respectively injected into the liquid chromatograph, and the chromatograms were recorded. 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 the guanine content shall not exceed 0.7%; The sum of the peak areas of other impurities 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

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 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).

Last Update：2022-01-01 12:00:10

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - 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 the filler; Methanol-water (10: 90) was used as the mobile phase; The detection wavelength was 254nm. Take 5ml of aciclovir reference solution, add 1ml of guanine and other related substances under the item of guanine reference solution, shake, take 20u1 injection human liquid chromatograph, adjust the chromatographic system, the resolution of acyclovir peak and guanine peak should meet the requirements.

assay

take about 50mg of this product, weigh it accurately, put it in a 50ml measuring flask, add 5ml of 0.4% sodium hydroxide solution to dissolve it, dilute it with water to the scale, shake it well, and take 2ml of it accurately, set it in a 100ml measuring flask, dilute it to scale with water, shake well, use it as a test solution, and inject it into a liquid chromatograph to record the chromatogram. According to the external standard method to calculate the peak area, that is.

Last Update：2022-01-01 12:00:10

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Category

Authoritative Data Verified Data

antiviral drugs.

Last Update：2022-01-01 12:00:11

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Storage

Authoritative Data Verified Data

light shielding, sealed storage.

Last Update：2022-01-01 12:00:11

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Aciclovir Tablets

Authoritative Data Verified Data

This product contains acyclovir (C8H11N503) should be 93.0% to 107.0% of the label.

trait

This product is white or off-white.

identification

take an appropriate amount of fine powder of this product (about 10mg equivalent to acyclovir), add 10ml of water, shake, filter, take the filtrate and add ammonia to prepare several drops of silver nitrate test solution, which will produce white flocculent precipitate.
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 continued filtrate under the content determination item was taken as the test solution; Another 10mg of guanine reference substance was taken, precision weighed and placed in a 50ml measuring flask, add 5ml of 0.4% sodium hydroxide solution to dissolve, dilute to scale with water, shake well, take 1ml with precision, put it in a ml measuring flask, dilute to scale with water, shake well, and use as a reference solution. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution and the reference solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded. Calculated by peak area as external standard method, containing guanine shall not exceed 1.0% of the labeled amount of acyclovir.
dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.lmol/L hydrochloric acid solution 900ml as the dissolution medium, the rotation speed is 50 revolutions per minute, according to the operation, after 30 minutes, take the solution 10ml, filter, take the appropriate amount of filtrate, with 0.1 mol/L hydrochloric acid solution was quantitatively diluted to prepare a solution containing about 10ug per 1 ml. According to UV-visible spectrophotometry (General rule 0401), immediately measure the absorbance at the wavelength of 254nm; Take the appropriate amount of acyclovir control, precision weighing, with 0.1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 10ug per 1 ml, which was measured 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 fine powder appropriate amount (about equivalent to acyclovir 50mg), put in 250ml measuring flask, add 0.4% sodium hydroxide solution 5ml, ultrasonic 1 min, add appropriate amount of water, shake in hot water bath for 10 minutes, cool, dilute to scale with water, shake, filter, take appropriate amount of filtrate accurately, A solution containing about 20ug per 1 ml was prepared by quantitative dilution with water, and as a test solution, it was measured and calculated according to the method under the item of acyclovir.

category

Same as acyclovir.

specification

(1)0.lg (2)0.2g (3)0.4g

storage

sealed storage.

Last Update：2022-01-01 12:00:11

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Acyclovir chewable tablets

Authoritative Data Verified Data

This product contains acyclovir (C8H11N503) should be labeled the amount of 93.0% to 107.0%.

trait

This product is white or off-white; Sweet.

identification

take an appropriate amount of fine powder of this product (about 10mg equivalent to acyclovir), add 10ml of water, shake, filter, take the filtrate and add several drops of silver nitrate test solution to produce white flocculent precipitate.
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

take the continued filtrate under the content determination item of guanine as the test solution; Take 10mg of guanine reference product, weigh it accurately, put it in a 50ml measuring flask, and add 5ml of 0.4% sodium hydroxide solution to dissolve it, dilute with water to the scale, shake, take 1 ml of precision, put in 100ml measuring flask, dilute with water to the scale, shake, as a reference solution. According to the chromatographic conditions under the content determination item, 20ul of the test solution and the reference solution are accurately measured, respectively injected into the human liquid chromatograph, the chromatogram is recorded, and the peak area is calculated according to the external standard method, guanine content should not exceed 1.0% of the labeled amount of acyclovir.
In addition to the disintegration time, the relevant provisions under the item of tablets (General Principle 0101) shall be met.

Content determination

Take 10 tablets of this product, precision weighing, fine grinding, precision weighing fine powder appropriate amount (about equivalent to acyclovir 50mg), put in 250ml measuring flask, add 0.4% sodium hydroxide solution 5ml, ultrasonic 1 min, add appropriate amount of water, shake in hot water bath for 10 minutes, let it cool, dilute to scale with water, shake well, filter, take appropriate amount of filtrate with precision, and dilute quantitatively with water to make a solution containing about 20ug per lml, as a test solution, the test solution was measured and calculated according to the method of acyclovir.

category

Same as acyclovir.

specification

0.4g

storage

sealed and stored in a dry place.

Last Update：2022-01-01 12:00:12

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Acyclovir cream

Authoritative Data Verified Data

This product contains acyclovir (C8H11N503) should be labeled the amount of 90.0% to 110.0%.

trait

This product is white cream.

identification

take 50ml of the filtrate of the test sample under the content determination item, put it in an evaporation dish, put it on a water bath and evaporate it to dryness, add 2ml of hydrochloric acid to the residue and put it on a water bath to evaporate it to dryness, then hydrochloric acid (1 ml) and potassium chlorate (about 30mg) were added. The residue was evaporated to dryness on a water bath.
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 filtrate under the content determination item was taken as the test solution; Another 10 mg of guanine reference substance was taken for precision weighing and placed in a 50ml measuring flask, add 5ml of 0.4% sodium hydroxide solution to dissolve, dilute to scale with water, shake well, take 1 ml with precision, put it in a 100ml measuring flask, dilute to scale with water, shake well, and use as a reference solution. According to the chromatographic conditions under the content determination item, 20ul of the test solution and the reference solution are respectively injected into the liquid chromatograph, the chromatogram is recorded, and the peak area is calculated according to the external standard method, the amount containing avidin should not exceed 1.0% of the labeled amount of acyclovir.
others should be in accordance with the relevant provisions under the term milk origin (General rule 0109).

Content determination

take an appropriate amount of this product (about 50mg equivalent to acyclovir), accurately weigh it, put it in a beaker, add 5ml of 0.4% sodium hydroxide solution, place it in a hot water bath for 1 minute, and mix well, add 5g of sodium vaporized with stirring, transfer to 250ml measuring flask with appropriate amount of hot water, shake in hot water bath for 10 minutes, let cool, dilute to scale with water, shake well, filter, an appropriate amount of the continuous filtrate was accurately taken and quantitatively diluted with water to prepare a solution containing about 20ug of acyclovir per 1 ml, which was obtained as a test solution, measured and calculated according to the method under the item acyclovir.

category

Same as acyclovir.

specification

storage

sealed and stored in a cool dark dry place.

Last Update：2022-01-01 12:00:13

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Aciclovir capsules

Authoritative Data Verified Data

This product contains 93.0% ~ 107.0% of the labeled amount of acyclovir.

trait

The contents of this product are white to off-white powder.

identification

take an appropriate amount of the content of this product (about 10mg equivalent to acyclovir), add 10ml of water, shake, filter, take the filtrate and add several drops of silver nitrate test solution to produce white flocculent precipitate.
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 filtrate under the content determination item was taken as the test solution; Another 10 mg of guanine reference substance was taken for precision weighing and placed in a 50ml measuring flask, add 5ml of 0.4% sodium hydroxide solution to dissolve, dilute to scale with water, shake well, take 1ml with precision, put it in a ml measuring flask, dilute to scale with water, shake well, and use as a reference solution. According to the chromatographic conditions under the content determination item, 20ul of the test solution and the reference solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded. According to the external standard method calculated by Peak area, containing avidin shall not exceed 1.0% of the labeled amount of acyclovir.
dissolution of this product, according to the dissolution and release determination method (General 0931 first method), with 0.lmol/L hydrochloric acid solution 900ml as the dissolution medium, the rotation speed is 100 revolutions per minute, according to the operation, after 30 minutes, take the solution 10ml, filter, take the appropriate amount of filtrate, with 0. The lmol/L hydrochloric acid solution is quantitatively diluted to prepare a solution containing about lOug per lml, and the absorbance is immediately measured at the wavelength of 254mn by ultraviolet-visible spectrophotometry (General rule 0401); take an appropriate amount of aciclovir control, precision weighing, with 0.1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 10ug per 1 ml, which was measured 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 difference of loading, mix evenly, weigh an appropriate amount (about 50mg equivalent to acyclovir) accurately, put it in a 250ml measuring flask, add 5ml of 0.4% sodium hydroxide solution, and sonicate for 1 min, add appropriate amount of water, shake in hot water bath for 10 minutes, let it cool, dilute to scale with water, shake well, filter, take appropriate amount of filtrate, dilute quantitatively with water to prepare about 1 ml of solution, as a test solution, the test solution was measured and calculated according to the method of acyclovir.

category

Same as acyclovir.

specification

0.2g

storage

sealed storage.

Last Update：2022-01-01 12:00:14

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Acyclovir and glucose injection

Authoritative Data Verified Data

This product is a sterile aqueous solution of acyclovir and glucose, containing acyclovir (C8H11N503) should be 95.0% ~ 105.0% of the label amount, containing glucose (C6H1206 • H20) should be 95.0% ~ 105.0% of the label amount.

trait

This product should be colorless or almost colorless clear liquid.

identification

take this product and slowly drop the warm alkaline copper tartrate solution to generate red precipitate of cuprous oxide.
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 pH value should be 3.5 to 0631 (general).
Guanine and other related substances: take 10ml of this product with precision, put it in a 50ml measuring flask, dilute it with water to scale, shake it well, and use it as a test solution, add 10mg of guanine reference product to 50ml of measuring flask, add 5ml of 0.4% sodium hydroxide solution to dissolve, dilute with water to the scale, shake, as a guanine reference stock solution; Take 1ml of precision, put in a 100ml measuring flask, add 2ml of 0.5% phosphoric acid solution, dilute with water to the scale, shake, as a guanine control solution. Determination of acyclovir guanine and related substances according to the method. 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 the guanine content shall not exceed 1.0% of the labeled amount of acyclovir; the sum of the peak areas of other impurities shall not be greater than the main peak area of the control solution (1.0%).
S-hydroxymethylfurfural an appropriate amount of a 5-hydroxymethylfurfural reference substance was accurately weighed, and dissolved in water and quantitatively diluted to a solution containing 3ug per 1 ml as a 5-hydroxymethylfurfural reference solution. According to the chromatographic conditions under the item of acyclovir content determination, the detection wavelength was 284nm. The standard solution of 5-hydroxymethylfurfural, the test solution of guanine and the test solution of other related substances, 20 u1 respectively, were accurately measured and injected into the human liquid chromatograph, and the chromatograms were recorded. The amount of 5-hydroxymethylfurfural contained in the test product shall not exceed 0.03% of the labeled amount of glucose calculated by the peak area according to the external standard method.
osmolality should be 250-0632 mosmol/kg (general rule).
take an appropriate amount of heavy metal (about 3g of glucose), evaporate to about 20ml, let it cool, add 2ml of acetate buffer (pH 3.5) and water to make 25ml, inspection by law (General Principles 0821, law I), the content of heavy metals must not exceed 5 parts per million of the amount of glucose marked.
bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per lml should be less than 1.0EU.
others should comply with the relevant provisions under injection (General 0102).

Content determination

accurate measurement of acyclovir an appropriate amount of this product is quantitatively diluted with water to prepare a solution containing about 20ug per 1 ml, which is used as a test solution and measured according to the method under the item of acyclovir content measurement.
glucose the content (g) of glucose (C6H1206 • H20) in the test product is obtained by measuring the optical rotation (General rule 0621) at 25 ° C. And multiplying it by 2.0852.

category

Same as acyclovir.

specification

100ml: acyclovir O.lg with glucose 5G
250ml: acyclovir 0.125g with glucose 12.5g
250ml: acyclovir 0.25g with glucose 12.5g

storage

It was sealed and stored at 10°C or higher.

Last Update：2022-01-01 12:00:15

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Aciclovir eye drops

Authoritative Data Verified Data

This product contains acyclovir (C8H1N503) should be labeled the amount of 90.0% to 110.0%.

trait

This product is a clear colorless liquid. At low temperature, there may be crystallization and precipitation, which is soluble at low temperature.

identification

take 20ml of this product, put it in an evaporation dish, put it on a water bath to dry, add 2ml of hydrochloric acid to the residue, put it on a water bath to dry, add lml of hydrochloric acid and about 30mg of potassium chlorate, put it on a water bath to dry, the residue was purplish red by adding ammonia solution Dropwise, followed by several drops of sodium hydroxide solution. The purplish red color disappeared.
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 pH value should be 7.5 to 9.0 (General 0631).
bird's eye precision: take an appropriate amount of this product and dilute it with water to make a solution containing 200ug of acyclovir per 1ml as a test solution; Take 10mg of Bird's methotrexate control, add 5ml of 0.4% sodium hydroxide solution to dissolve, dilute with water to the scale, shake well, take 1ml of precision measurement, put in 100ml measuring flask, dilute with water to the scale, shake well as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution and the reference solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded. According to the external standard method calculated by Peak area, containing avidin shall not exceed 1.0% of the labeled amount of acyclovir.
ethylparaben, benzalkonium and thimerosal were selected and measured according to the bacteriostatic agent used. Determined by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; 1% triethylamine solution (adjusted to pH 3.0 with phosphoric acid) as mobile phase A, methanol as mobile Phase B, the gradient elution was carried out as follows; The detection wavelength was 262mn. The degree of separation between ethyl paraben peak, benzalkonium bromide peak and thimerosal peak shall be in accordance with the regulations.
about 20mg of thiomersal reference material was weighed accurately, dissolved with water and diluted to 100ml, and used as stock solution of thiomersal; About 25mg of benzalkonium bromide reference material was weighed accurately, dissolved with water and diluted to 50ml, as a stock solution of benzalkonium bromide; 25mg of a reference substance of ethylparaben was accurately weighed, placed in a 100ml measuring flask, and 5ml of ethanol was added to dissolve and diluted to the mark with water, as a stock solution of ethylparaben. The thiomersal stock solution 5MK, the benzalkonium bromide stock solution 10ml and the ethylparaben stock solution 1ml were respectively precisely weighed in the same 50ml measuring flask, diluted to the mark with water, and shaken well, as a mixed reference solution. Take this product as a test solution (containing thimerosal, benzalkonium bromide sample), or take this product 2ml, 100ml flask, diluted with water to the scale, shake, as a test solution (sample containing ethylparaben). 20 u1 of the test solution and the mixed reference solution were respectively injected into the liquid chromatograph, and the chromatograms were recorded. According to the external standard method and the peak area, the amount of the test product containing ethylparaben, benzalkonium bromide or thimerosal bacteriostatic agent shall not exceed 120% of the labeled amount.
The osmolality should be 250 to 310 mosmol/kg (General 0632).
others shall comply with the relevant provisions under Ophthalmic Preparations (General rule 0105).

Content determination

an appropriate amount of this product was quantitatively diluted with water to prepare a solution containing about 20ug of acyclovir per 1 ml, which was used as a test solution and measured according to the method of acyclovir.

category

Same as acyclovir.

specification

(1)0.5ml:0.5mg (2)5ml:5mg (3)8ml:8mg

storage

sealed, stored in the cool dark.

Last Update：2022-01-01 12:00:16

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Aciclovir Granules

Authoritative Data Verified Data

This product contains acyclovir (C8H11N503) should be labeled the amount of 90.0% to 110.0%.

trait

This product is white to off-white soluble particles; Taste slightly sweet.

identification

take an appropriate amount of fine powder of this product (about 10mg equivalent to acyclovir), add 10ml of water, shake, filter, take the filtrate and add several drops of silver nitrate test solution to produce white flocculent precipitate.
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

weight loss on drying the product shall be dried at 105°C to constant weight (General rule 0831), and the weight loss shall not exceed 6.0%.
take the continued filtrate under the content determination item of guanine as the test solution; Take 10mg of guanine reference product, weigh it accurately, put it in a 50ml measuring flask, and add 5ml of 0.4% sodium hydroxide solution to dissolve it, dilute with water to the scale, shake, take 1 ml of precision, put in 100ml measuring flask, dilute with water to the scale, shake, as a reference solution. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution and the reference solution are accurately measured, respectively injected into the human liquid chromatograph, the chromatogram is recorded, and the peak area is calculated according to the external standard method, containing guanine not exceeding 1.0% of the labeled amount of acyclovir.
others should comply with the relevant provisions under The granule (General Principle 0104).

Content determination

take the contents under the difference of loading amount, grind them finely, mix them evenly, weigh an appropriate amount (about 50mg equivalent to acyclovir) precisely, put them in a 250ml measuring flask, and add 5ml of 0.4% sodium hydroxide solution, ultrasonic wave for 1 min, add appropriate amount of water, shake in hot water bath for 10 min, cool, dilute to scale with water, shake, filter, take appropriate amount of filtrate with precision, A solution containing about 20% per 1 ml was prepared by quantitative dilution with water. As a test solution, the solution was measured and calculated according to the method under the item of acyclovir.

category

Same as acyclovir.

specification

0.2g

storage

sealed storage.

Last Update：2022-01-01 12:00:17

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Aciclovir for Injection

Authoritative Data Verified Data

This product is acyclovir plus sodium hydroxide solution, freeze-dried or spray-dried and then made of sterile products. The content of acyclovir (C8H11N503) shall be between 90.0% and 110.0% of the labeled amount calculated as the average loading.

trait

This product is white powder or loose lumps.

identification

take about 20mg of this product, add 2ml of hydrochloric acid, and dry it on water bath, then add about 30mg of hydrochloric acid and potassium chlorate, and dry it on water bath, and add ammonia test solution to the residue, after adding several drops of sodium hydroxide solution, the purple color disappeared.
take an appropriate amount of the content of this product (about 10mg equivalent to acyclovir), add 10ml of water, shake to dissolve, add several drops of silver nitrate test solution to produce white flocculent precipitate.
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 product of the aqueous solution of sodium salt identification (1) of the reaction (General 0301).
(1) and (2) above can be selected.

examination

alkalinity this product is dissolved in water and diluted to prepare a solution containing about 12.5mg of acyclovir per 1 ml, which is measured according to law (General rule 0631). The pH value should be 10.5~11.5.
clarity and color of solution take this product, add water to dissolve and dilute to make a solution containing about 50mg of acyclovir per 1 ml, the solution should be clear and colorless; If it is turbid, it should not be more concentrated than the turbidity standard solution No. 2 (General rule 0902 method 1); If the color is colored, it should not be deeper than the yellow or yellow-green standard solution No. 1 (General rule 0901 method 1).
the appropriate amount of the content under the difference between guanine and other related substances (about 50mg equivalent to acyclovir) shall be accurately weighed, placed in a 250ml measuring flask, dissolved with water and diluted to the scale, shake, as a test solution, according to the method under acyclovir measurement. 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 the guanine content shall not exceed 1.0% of the labeled amount of acyclovir; the sum of the peak areas of other impurities shall not be greater than the main peak area 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 5.5%, first method 1).
bacterial endotoxin this product is taken and checked according to law (General rule 1143). The amount of endotoxin contained in acyclovir per 1 mg should be less than 0.17EU.
others should comply with the relevant provisions under injection (General 0102).

Content determination

take an appropriate amount of content (about 50mg equivalent to acyclovir) under the difference of loading amount, weigh it accurately, put it in a 250ml measuring flask, dissolve it with water, dilute it to the scale, shake it well, A solution containing 20ug of acyclovir per 1 ml was prepared by quantitatively diluting an appropriate amount with water. As a test solution, the solution was measured and calculated according to the method of acyclovir.

category

Same as acyclovir.

specification

(1)0.25g (2)0.5g

storage

light shielding, closed storage.

Last Update：2022-01-01 12:00:18

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one

Hefei TNJ Chemical Industry Co.,Ltd.

Product Name: acycloguanosine Request for quotation
CAS: 59277-89-3
Tel: 0086-551-65418684
Email: sales@tnjchem.com
　　　　 info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840

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: Aciclovir Visit Supplier Webpage Request for quotation
CAS: 59277-89-3
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409

Wechat: 18301782025

Hefei TNJ Chemical Industry Co.,Ltd.

Product Name: acycloguanosine Request for quotation
CAS: 59277-89-3
Tel: 0086-551-65418684
Email: sales@tnjchem.com
　　　　 info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840

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: Aciclovir Visit Supplier Webpage Request for quotation
CAS: 59277-89-3
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409

Wechat: 18301782025

View History

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one
2'-氟-[1,1'-联苯]-4-羧酸
mk0244

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one Request for Quotation

acycloguanosine

CAS: 59277-89-3

Molecular Formula: C8H11N5O3

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Names and Identifiers

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Physico-chemical Properties

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Risk and Safety

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Reference

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Nature

Open Data Verified Data

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Preparation Method

Open Data Verified Data

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Standard

Authoritative Data Verified Data

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Trait

Authoritative Data Verified Data

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Introduction

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Use

Open Data Verified Data

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Differential diagnosis

Authoritative Data Verified Data

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Safety

Open Data Verified Data

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Exam

Authoritative Data Verified Data

clarity and color of solution

Related substances

Bird Midge and other related substances

loss on drying

ignition residue

Heavy metals

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Content determination

Authoritative Data Verified Data

chromatographic conditions and system suitability test

assay

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Category

Authoritative Data Verified Data

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Storage

Authoritative Data Verified Data

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Aciclovir Tablets

Authoritative Data Verified Data

trait

identification

examination

Content determination

category

specification

storage

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Acyclovir chewable tablets

Authoritative Data Verified Data

trait

identification

examination

Content determination

category

specification

storage

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Acyclovir cream

Authoritative Data Verified Data

trait

identification

examination

Content determination

category

specification

storage

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Aciclovir capsules

Authoritative Data Verified Data

trait

identification

examination

Content determination

category

specification

storage

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one - Acyclovir and glucose injection

Authoritative Data Verified Data

trait

identification

examination

2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6h-purin-6-one