Adenosine 3′,5′-Cyclic Monophosphate (Cyclic AMP; cAMP) CAS 60-92-4 Assay 97.0%~103.0% (HPLC)

Basic Information
Contains NLT 97.0% and NMT 103.0% of C10H12N5O6P, calculated on the dried basis.
Characteristics
This product is white or white powder, odorless.
This product is slightly soluble in water and almost insoluble in ethanol or ether.
Identify
1. Take about 10mg of this product, dissolve it with 1ml dilute nitric acid, add 1ml ammonium molybdate test solution, heat for a few minutes, cool it, precipitate yellow precipitate.
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 control solution.
Analysis
Acidity
After taking 0.10g of this product and dissolving it with 50mL of water, determine according to law (general rule 0631), and the pH value should be 2.0~4.0.
Clarity and color of the solution
After taking 0.10g of this product and dissolving it with 50mL of water, check according to law (general rule 0901 first method and general rule 0902 first method), the solution should be clear and colorless.
Related substance
According to high performance liquid chromatography (general rule 0512) determination.
Test product solution: Take this product, dissolve it with water and dilute it quantitatively into a solution containing about 0.5mg per 1mL.
Control solution: Accurately measure 1mL of the test product solution, place it in a 100mL measuring bottle, dilute it with water to the scale, and shake well.
System suitability solution: Take about 10mg of cyclic adenosine reference product, add 5mL of water to dissolve it, add 1mol/L hydrochloric acid solution to 1mL, heat in a water bath for 30 minutes, then cool it, adjust it to neutral with sodium hydroxide test solution, and dilute it with water to make a solution containing about 0.2mg per 1mL.
Chromatographic conditions: Octadecylsilane bonded silica gel was used as the filling agent, a mixture of potassium dihydrogen phosphate solution and tetrabutylammonium bromide (6.8g potassium dihydrogen phosphate and 3.2g tetrabutylammonium bromide were dissolved with water and diluted to 1000mL, shaken well, and the pH value was adjusted with phosphoric acid to 4.3) -acetonitrile (85:15) was used as the mobile phase, and the detection wavelength was 258nm. The sample volume is 20μL.
System suitability requirements: In the chromatogram of system suitability solution, the separation degree of adenosine cyclic phosphorus peak and adjacent impurity peak should meet the requirements. The theoretical plate number calculated by the peak of cyclic adenosine phosphate should not be less than 2000, and the trailing factor should be less than 1.4.
Determination method: The test solution and control solution were precisely measured and injected into the liquid chromatograph respectively, and the chromatogram was recorded to about 4 times the retention time of the main peak (to the peak of adenosine triphosphate).
Limit: If there are impurity peaks in the chromatogram of the test solution, the sum of the impurity peak areas shall not be greater than the main peak area of the control solution (1.0%).
Loss on drying
Take this product, dry at 105℃ to constant weight, weight loss shall not exceed 10.0% (general rule 0831).
Residue on ignition
Take 1.0g of this product, place it in a platinum crucible, check according to law (General rule 0841), and the remaining residue shall not exceed 0.1%.
Heavy metals
Take 0.50g of this product, check according to law (General rule 0821 third Law), containing heavy metals shall not exceed 20 parts per million.
Bacterial endotoxin
Take this product, check according to law (general rule 1143), the amount of endotoxin contained in 1mg of cyclic adenosine phosphorus should be less than 3.75EU.
Content determination
According to high performance liquid chromatography (general rule 0512) determination.
Test solution
Take an appropriate amount of this product, weigh it accurately, dissolve it with water and dilute it quantitatively to make a solution containing about 0.1mg per 1mL.
Reference solution
Appropriate amount of cyclic adenosine was taken from the control product, accurately weighed, dissolved with water and quantitatively diluted to make a solution containing about 0.1mg per 1mL.
System suitability solutions, chromatographic conditions and system suitability requirements
See related substances.
Measurement method
The test solution and the control solution were precisely measured, injected into the liquid chromatograph respectively, and the chromatogram was recorded. The peak area is calculated by external standard method.
Category Vasodilators.
Storage Seal tightly and store in a cool place.
Inhibitor Cyclic AMP for injection.