INOSINE
Inosine
CAS: 58-63-9
Molecular Formula: C10H12N4O5
INOSINE - Names and Identifiers
| Name | Inosine |
| Synonyms | HXR Atorel Inosine beta-Inosine hypoxanthined-riboside hypoxanthinenucleoside Hypoxanthine D-riboside Hypoxanthine ribonucleoside Hypoxanthine-9-beta-D-ribofuranoside Hypoxanthine, 9-beta-D-ribofuranosyl- beta-D-Ribofuranoside, hypoxanthine-9 9-pentofuranosyl-3,9-dihydro-6H-purin-6-one 9-(alpha-D-xylofuranosyl)-3,9-dihydro-6H-purin-6-one |
| CAS | 58-63-9 |
| EINECS | 200-390-4 |
| InChI | InChI=1/C10H12N4O5/c15-1-4-6(16)7(17)10(19-4)14-3-13-5-8(14)11-2-12-9(5)18/h2-4,6-7,10,15-17H,1H2,(H,11,12,18)/t4-,6-,7-,10?/m1/s1 |
| InChIKey | UGQMRVRMYYASKQ-PKJMTWSGSA-N |
INOSINE - Physico-chemical Properties
| Molecular Formula | C10H12N4O5 |
| Molar Mass | 268.23 |
| Density | 1.3846 (rough estimate) |
| Melting Point | 222-226 °C (dec.) (lit.) |
| Boling Point | 226 C (dec.) |
| Specific Rotation(α) | -49.2 º (c=1,H2O 18 ºC) |
| Flash Point | 397°C |
| Water Solubility | 2.1 g/100 mL (20 ºC) |
| Solubility | Slightly soluble in water, insoluble in chloroform and ethanol, and easily soluble in alkaline solutions such as dilute hydrochloric acid or sodium hydroxide. |
| Vapor Presure | 1.52E-22mmHg at 25°C |
| Appearance | White crystalline powder |
| Color | White |
| Odor | Odorless |
| Merck | 14,4975 |
| BRN | 624889 |
| pKa | 13.24±0.70(Predicted) |
| Storage Condition | Keep in dark place,Sealed in dry,Room Temperature |
| Stability | Hygroscopic |
| Refractive Index | -52 ° (C=1, H2O) |
| MDL | MFCD00066770 |
| Physical and Chemical Properties | This product is white crystalline powder; Odorless; Slightly bitter taste. Slightly soluble in water, insoluble in chloroform, ethanol, in dilute hydrochloric acid or sodium hydroxide and other alkali solution soluble. The saturated aqueous solution of this product contains about 1.5% of inosine. mp218 C (decomposition). |
| Use | Used as a coenzyme drug |
INOSINE - Risk and Safety
| Hazard Symbols | Xi - Irritant |
| Risk Codes | 36/37/38 - Irritating to eyes, respiratory system and skin. |
| Safety Description | 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. |
| WGK Germany | 2 |
| RTECS | NM7460000 |
| FLUKA BRAND F CODES | 10 |
| TSCA | Yes |
| HS Code | 29389090 |
| Toxicity | LD50 oral in rat: > 10gm/kg |
INOSINE - Nature
Open Data Verified Data
- This product is white crystalline powder; Odorless; Slightly bitter taste. In chloroform, ethanol insoluble in dilute hydrochloric acid or hydroxide solution soluble. The saturated aqueous solution of this product contains about 1.5% inosine. Melting point 218 °c (decomposition).
- This product is a normal component of the human body, is an intermediate product of nucleotide metabolism in the body, under the action of the relevant enzymes, can form hypoxanthine nucleoside, and further converted into adenine nucleotides or guanine nucleotides, this also provides a starting material for the synthesis of ATP. It can directly enter the cell, participate in glucose metabolism, improve the activity of coenzyme A and activate Pyruvate oxidase, so that the cells in the low energy and hypoxia state continue to carry on the metabolism smoothly, which is helpful to the recovery of the function of the damaged liver cells.
Last Update：2024-01-02 23:10:35
INOSINE - Preparation Method
Open Data Verified Data
(1) Corynebacterium fermentation inosinic acid, and then take off the chemical phosphate inosine. (2) with adenine and thiamine double auxotrophic mutant Bacillus strain, one-step fermentation preparation of inosine.
Last Update：2022-01-01 11:12:46
INOSINE - Standard
Authoritative Data Verified Data
This product is 9b-d-ribose hypoxanthine. The content of C10H12N4O5 shall be between 98.0% and 102.0% calculated on the dried product.
Last Update：2024-01-02 23:10:35
INOSINE - Trait
Authoritative Data Verified Data
- This product is white crystalline powder; Odorless.
- This product is slightly soluble in water, insoluble in ethanol, and soluble in dilute hydrochloric acid and sodium hydroxide solution.
Last Update：2022-01-01 11:53:27
INOSINE - Use
Open Data Verified Data
- for white blood cells or thrombocytopenia, liver disease and heart disease.
- usage and dosage for heart disease, 0.2~0.4G each time, for liver disease, 0.4~0. 8g each time. All were 3 times a day. Intravenous injection or infusion, 0.2~0. 6G each time, 1~2 times a day. Ophthalmic application after injection of eyeball, each time 40mg,8 days 1 times, 5 times for a course of treatment.
Last Update：2022-01-01 11:12:47
INOSINE - Differential diagnosis
Authoritative Data Verified Data
- take the right amount of 0.01% solution of this product, add equal volume of 3, 5-dihydroxytoluene solution (take 3, 5-dihydroxytoluene and ferric chloride 0.lg, add hydrochloric acid to make 100ml), mix well, after heating in a water bath for about 10 minutes, a green color was observed.
- 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 605).
Last Update：2022-01-01 11:53:28
INOSINE - Safety
Open Data Verified Data
- can cause mild Diarrhea, not with orotic acid, chloramphenicol, Dipyridamole and thiopental sodium injection.
- under shading, sealed and preserved.
Last Update：2022-01-01 11:12:47
INOSINE - Exam
Authoritative Data Verified Data
transmittance of solution
take 0.5g of this product, add 50ml of water to dissolve, according to UV-visible spectrophotometry (General rule 0401), determine the transmittance at 430nm wavelength, not less than 98.0%. (For injection)
Related substances
take this product, add water to dissolve and dilute to make a solution containing 0.5mg per 1ml as a test solution; Take 1ml for precision measurement, put it in a 100ml measuring flask, dilute it with water to the scale, as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution and the control solution are respectively injected into the liquid chromatograph, and the chromatogram is recorded to 2 times of the retention time of the main 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 1.0% (General rule 0831).
ignition residue
not more than 0.1% (for injection), or not more than 0.2% (for oral use) (General rule 0841).
Heavy metals
take this product 1.0g, inspection according to law (General Principles 0821 second law), containing heavy metals shall not exceed 10 parts per million.
abnormal toxicity
take this product, add sodium chloride injection to dissolve and dilute the solution containing inosine lOmg per lml, check according to law (General rule 1141), should comply with the provisions. (For injection)
Last Update：2022-01-01 11:53:29
INOSINE - 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 248nm. Take about 10mg of inosine reference, add 1 mol/L hydrochloric acid solution (1ml), heat in water bath at 80 ℃ for 10 minutes, let it cool, add 1ml of 1 mol/L sodium hydroxide solution, add water to 50ml, 20u1 injection liquid chromatograph, adjust the chromatographic system, the separation degree of inosine peak and adjacent impurity peak should meet the requirements, the number of theoretical plate according to the inosine peak calculation is not less than 2000.
assay
take an appropriate amount of this product, accurately weigh it, add water to dissolve and quantitatively dilute it to make a solution containing about 20ug per lml, shake it, and use it as a test solution, A 20ul injection liquid chromatograph was accurately measured and the chromatogram was recorded. An appropriate amount of inosine reference was accurately weighed and determined by the same method, and the peak area was calculated according to the external standard method.
Last Update：2022-01-01 11:53:29
INOSINE - Category
Authoritative Data Verified Data
cell metabolism improving drugs.
Last Update：2022-01-01 11:53:29
INOSINE - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 11:53:30
INOSINE - Inosine Oral Solution
Authoritative Data Verified Data
This product contains inosine (C10H12N4O5) should be 90.0% to 110.0% of the label children.
trait
This product is colorless to yellowish liquid.
identification
take this product, according to the item (2) under the identification of inosine test, showed the same results.
examination
- the pH value should be 7.5 to 8.5 (General 0631).
- others should comply with the relevant provisions under the item of oral solution (General rule 0123).
Content determination
precision take an appropriate amount of this product, quantitatively dilute with water to make a solution containing about 20ug of inosine per 1 ml, as a test solution, measure and calculate according to the method under the item of inosine.
category
Same as inosine.
specification
(l)10ml:O.lg (2)10ml:0.2g (3)20ml:0.2g (4)20ml: 0.4g
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:53:30
INOSINE - Inosine tablets
Authoritative Data Verified Data
This product contains inosine (C10H12N4O5) should be 93.0% to 107.0% of the label.
trait
This product is white tablet or sugar-coated tablet or film-coated tablet, White after removing the coating.
identification
- Take 2 tablets of this product, triturate, add 10ml of water, shake to dissolve inosine, filter, take filtrate, according to the identification (1) Test under the item of inosine, show the same reaction.
- 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 second method), water 900ml as the dissolution medium, the speed of 75 rpm, according to the law, after 30 minutes, take 10ml of the solution, filter, take 5ml of the filtrate accurately, put it in a 100ml measuring flask, dilute it with water to the scale, shake it well, according to UV-visible spectrophotometry (General rule 0401), measure absorbance at the wavelength of 248nm; Take appropriate amount of inosine reference substance, water was added to dissolve and quantitatively diluted to prepare a solution containing about 10ug 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 10 tablets of this product (if it is sugar-coated tablets, the coating should be removed), precise weighing, fine grinding, precise weighing to take an appropriate amount (about equivalent to inosine O.lg), put it in a 100ml measuring flask, add about 70ml of water, fully shake to dissolve inosine, dilute to the scale with water, shake well, filter, and take 2ml of continuous filtrate with precision, in a 100ml measuring flask, dilute to the scale with water, shake well, as a test solution, measure and calculate according to the method under the item of inosine.
category
Same as inosine.
specification
0.2g
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:53:31
INOSINE - Inosine Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of inosine. The inosine content (C10H12N4O5) shall be between 90.0% and 110.0% of the labeled amount.
trait
This product is colorless or almost colorless clear liquid.
identification
take this product, according to the item of inosine identification (1), (2) test, showed the same results.
examination
- the pH value should be 8.5 to 9.5 (General 0631).
- appropriate amount of related substances should be taken and diluted with water to make a solution containing 0.5mg of inosine per 1ml, which should be used as a test solution; 1ml should be accurately measured and placed in a 50ml measuring flask, as a control solution, it was diluted to the scale with water and shaken. Determination according to the method under the item of inosine related substances. 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 (2.0%).
- abnormal toxicity of this product, diluted with sodium chloride injection to prepare a solution containing inosine lOmg per lml, and checked according to law (General rule 1141), should comply with the provisions.
- bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per 1 mg inosine should be less than 0.25EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
precision take an appropriate amount of this product, diluted with water to make a solution containing about 20ug of inosine per 1 ml, as a test solution, according to the method under the item of inosine determination, calculation, that is.
category
Same as inosine.
specification
(l)2ml:50mg (2) 2ml:lOOmg (3) 5ml:lOOmg (4)5ml:200mg (5) 10ml:500mg
storage
light shielding, closed storage.
Last Update：2022-01-01 11:53:32
INOSINE - Inosine capsules
Authoritative Data Verified Data
This product contains inosine (C10H12N4O5) 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 (equivalent to 0.2g of inosine), add 10ml of water to shake, dissolve inosine, filter, take the filtrate, according to the identification of inosine (1) one trial showed the same response.
- 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
should comply with the relevant provisions under the capsule (General rule 0103).
Content determination
take the contents under the difference of loading amount, grind evenly, weigh an appropriate amount (about 0.lg of inosine) accurately, put it in a 100ml measuring flask, and add about 70ml of water, fully shake to dissolve inosine, dilute to scale with water, shake well, filter, precisely take 2ml of continuous filtrate, put it in 100ml measuring flask, dilute to scale with water, shake well, as the test solution, according to the method under the item of inosine measurement, calculation, that is obtained.
category
Same as inosine.
specification
0.2g
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:53:32
INOSINE - Inosine and glucose injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of inosine and glucose. Inosine (C10H12N405) shall be between 90.0% and 110.0% of the label amount and glucose (C6H1206 • H20) shall be between 95.0% and 105.0% of the label amount.
trait
This product is a clear colorless liquid.
identification
- take this product, according to the identification (1) Test under the item of inosine, show the same reaction.
- take this product and slowly drop it into the warm alkaline copper tartrate test solution to generate red precipitate of cuprous oxide.
- in the chromatogram recorded under the determination of inosine content, 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
- the pH value should be 4.0 to 6.0 (General 0631).
- appropriate amount of related substances should be taken and diluted with water to make a solution containing 0.2 mg of inosine per 1ml, which should be used as a test solution. Take 1ml for precision measurement and put it in a 100ml measuring flask, as a control solution, it was diluted to the scale with water and shaken. Determination according to the method under the item of inosine related substances. 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%).
- 5-hydroxymethylfurfural an appropriate amount of 5-hydroxymethylfurfural reference substance was accurately weighed, dissolved with water and quantitatively diluted to prepare a solution containing 1.0ug per 1 ml, which was used as the reference solution; take an appropriate amount of this product and dilute it quantitatively with water to make a solution containing 5mg of glucose per 1 ml as a test solution. According to the chromatographic condition test under the item of related substances, the detection wavelength was 284nm. Take 10 u1 of each of the reference solution and the test solution, respectively inject the human liquid chromatograph, and record the chromatogram. If there is a peak corresponding to the retention time of 5-hydroxymethylfurfural in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and the content of 5-hydroxymethylfurfural shall not exceed 0.02% of the labeled amount of glucose.
- take 50ml of heavy metal, evaporate to about 3.5, let it cool, add 2ml of acetate buffer (pH 0821) and an appropriate amount of water to make 25ml, and check it according to law (General rule first law), heavy metals should not exceed three million of the labeled amount of glucose. The osmolality should be between 270 and 0632 mosmol/kg (general).
- 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
- precise amount of inosine: take an appropriate amount of this product and quantitatively dilute it with water to make a solution containing about 20% inosine per 1 ml, which is used as a test solution, and then measure and calculate according to the method under the item of inosine, that's right.
- glucose this product was taken and measured by optical rotation spectrophotometry (General rule 0621) at 25 ° C., and the content of C10H12N405 was calculated by the following formula.
category
Same as inosine.
specification
- lOOml: inosine 0.2g and glucose 5.0g
- 100ml: inosine 0.6g and glucose 5.0g
- 200ml: inosine 0.4g with glucose 10G
- 250ml: inosine 0.6g with glucose 12.5g
storage
light shielding, closed storage.
Last Update：2022-01-01 11:53:33
INOSINE - Inosine and Sodium Chloride Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of inosine and sodium chloride. Inosine-containing (C10H12N405) shall be 90.0% to 110.0% of the label amount and sodium chloride (NaCl) shall be 95.0% to 105.0% of the label amount.
trait
This product is a clear colorless liquid.
identification
- The product was taken and the same results were shown in the identification tests (1) and (2) under the item of inosine.
- This product shows the reaction of sodium salt identification (1) and chloride identification (1) (General rule 0301).
examination
- the pH value should be 6.0 to 8.0 (General 0631).
- appropriate amount of related substances should be taken and diluted with water to make a solution containing 0.5mg of inosine per 1ml, which should be used as a test solution; 1ml should be accurately measured and placed in a 100ml measuring flask, as a control solution, it was diluted to the scale with water and shaken. Determination according to the method under the item of inosine related substances. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area (except the sodium chloride peak) shall not be greater than the main peak area of the control solution (1.0%).
- take 50ml of heavy metal, evaporate to about 20ml, let it cool, add 2ml of acetate buffer (pH3.5) and an appropriate amount of water to make 25ml, and check it according to law (General rule 0821, Law 1), heavy metals should not exceed three million.
- The osmolality should be 270 to 320 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
precise amount of inosine take an appropriate amount of this product and quantitatively dilute it with water to make a solution containing about 20 puffs of inosine per lml, which is used as a test solution, and measure and calculate according to the method under the item of inosine, that's right.
Sodium chloride precision take 10ml of this product, plus nitric acid 5ml, precision plus silver nitrate titration solution (0.lmol/L)25ml, plus dibutyl phthalate 3ml, after strong shaking, add ammonium ferric sulfate indicator solution 2ml, with ammonium thiocyanate titration solution (0.1 mol/L) titration, and the results of the titration were corrected with a blank test. Each 1 ml of silver nitrate titration solution (0.1 mol/L) corresponds to 5.844mg of NaCl.
category
Same as inosine.
specification
- 100ml: inosine 0.2g with sodium chloride 0.87g
- 100ml: inosine 0.2g and sodium chloride 0.9g
- 100ml: inosine 0.3g and sodium chloride 0.9g
- 100ml: inosine 0.5g with sodium chloride 0.9g
- 100ml: inosine 0.6g with sodium chloride 0.9g
- 200ml: inosine 0.4g with sodium chloride 1.8g
- 250ml: inosine 0.5g with sodium chloride 2.25g
storage
light shielding, closed storage.
Last Update：2022-01-01 11:53:34
INOSINE - Inosine for Injection
Authoritative Data Verified Data
This product is a sterile lyophilized product of inosine. The inosine content (C10H12N4O5) shall be between 90.0% and 110.0% of the labeled amount calculated as the average loading.
trait
This product is white loose lumps or powder.
identification
take this product, according to the item of inosine identification (1), (2) test, showed the same results.
examination
- alkalinity: take this product, add water to dissolve and dilute to make a solution containing about 50mg of inosine per 1 ml, and measure it according to law (General rule 0631). The pH value should be 8.5~9.5.
- clarity of solution: Take appropriate amount of this product, add water to dissolve and dilute to prepare a solution containing about 10 mg of inosine per 1 ml, according to UV-Vis spectrophotometry (General 0401), the light transmittance was measured at a wavelength of 430mn., not less than 98.0%.
- Related substances take this product, add water to dissolve and dilute to make a solution containing 0.5mg inosine per 1ml as a test solution; Take 1ml for precision measurement and put it in a 100ml measuring flask, as a control solution, it was diluted to the scale with water and shaken. According to the determination method under the item of inosine related substances, the chromatogram was recorded to 4 times of the retention time of the main 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%).
- weight loss on drying this product shall be dried to constant weight at 105°C, and the weight loss shall not exceed 5.0% (General rule 0831).
- abnormal toxicity: take this product, add sodium chloride injection to dissolve and dilute to prepare a solution containing 10 mg of inosine per lml, and check according to law (General rule 1141), and meet the requirements.
- bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per 1 mg inosine should be less than 0.25EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
appropriate amount of mixed content (about equivalent to 0.lg of inosine) under the item of difference in loading amount shall be accurately weighed, dissolved and quantitatively diluted with water to make a solution containing about 20ug of inosine per lml, as the test solution, according to the method under the item of inosine measurement, calculation, that is obtained.
category
Same as inosine.
specification
(l)0.2g (2)0.3g (3)0.4g (4)0.5g(5)0.6g
storage
light shielding, closed storage.
Last Update：2022-01-01 11:53:35
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