Inosine CAS 58-63-9 Assay 98.0~102.0% Factory High Quality

Inosine (CAS: 58-63-9) ChP2020 Test Method
Inosine - DEFINITION
The content of C10H12N4O5 shall be between 98.0% and 102.0% calculated on the dried product.
Inosine - Trait 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.
Inosine - IDENTIFICATION
1. 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.
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. The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 605).
Inosine - Analysis
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).
Residue on Ignition (Sulfated)
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 10mg per 1ml, check according to law (General rule 1141), should comply with the provisions. (For injection)
Inosine - Content determination
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.
Inosine - Category
Cell metabolism improving drugs.
Inosine - Storage
Light shielding, sealed storage.
Pharmaceuticals: (1) Inosine Oral Solution (2) Inosine Tablets (3) Inosine Injection (4) Inosine Capsules (5) Inosine and Glucose Injection (6) Inosine and Sodium Chloride Injection (7) Inosine for Injection