Molecular Formula | C22H38O5 |
Molar Mass | 382.54 |
Density | 1.096±0.06 g/cm3(Predicted) |
Boling Point | 501.7±50.0 °C(Predicted) |
pKa | 14.66±0.29(Predicted) |
Use | Prostaglandin drugs for termination of early pregnancy, mid-term labor induction, etc |
This product is (Z)-7-[(lR, 2R,3R, 5S)-3, 5-dihydroxy-2-[(E)-(3S)-3-methyl-1-octene-3-hydroxy] cyclopentyl]-5-heptanoic acid methyl ester. Calculated as dried product, the content of C22H38O5 shall not be less than 91.0%.
take this product, add methylated solution and dilute to make a solution containing about 0.2mg per lml as a test solution; Take 2ml for precision measurement and put it in a 50ml measuring flask, as a control solution, it was diluted to the scale with methanol and shaken. According to the chromatographic conditions under the item of Holter determination, 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 component peak. If there are 15-episomer chromatographic peaks corresponding to those in the test solution for system suitability in the chromatogram of the test solution, the peak area shall not be greater than that of the main peak area of the control solution (4.0%).
take this product, put it in a phosphorus pentoxide dryer, and dry it under reduced pressure for 24 hours. The weight loss shall not exceed 3.0% (General rule 0831).
measured by high performance liquid chromatography (General rule still 12).
with eighteen alkyl silane bonded silica gel as the filler; Methanol-water (70:30) as the mobile phase; The detection wavelength was 202 nm, dissolving and diluting the fermentation broth to make a solution containing about 0.2mg of each 15-episomer and carboprost methyl ester in 1 ml, as the system suitability test solution, taking 20u1 injection human liquid chromatograph, the theoretical plate number is not less than 2000 calculated by the carboprost methyl ester peak, and the separation degree between the 15-episomer peak and the carboprost methyl ester peak should be greater than 1.2.
take an appropriate amount of this product, weigh it accurately, dissolve it with fermentation and dilute it quantitatively to make a solution containing 0.2mg per 1 ml, and use it as a sample solution, and take 20ul for precision measurement, inject into liquid chromatograph, record the chromatogram; Take the carboprost methyl ester reference substance, with the same method, according to the external standard method to calculate the peak area, obtained.
prostaglandins.
shading, sealing, low temperature (below -5°C) storage.
This product contains carboprost methyl ester (C22H38O5) should be 90.0% ~ 110.0% of the label amount.
This product is milky white to light yellow suppository.
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.
should comply with the relevant provisions under suppository (General rule 0107).
Take 10 capsules of this product, precise weighing, let them grind in an onyx mortar, weigh an appropriate amount (about 2mg equivalent to carboprost methyl ester) precisely, and put them in a sealed Erlenmeyer flask, add methylated 10ml accurately, plug, place in water bath at 45°C, sonicate for about 3 minutes to dissolve methyl carboprost, take it out, put it in ice bath, and centrifuge it after the matrix solidifies, put it to room temperature, take the solution as a test solution, and take 20 u1 for precision children, and measure it according to the method under the item of determination of carprost nail content.
methyl isocarboprost.
(1)0.5mg (2)lmg
shading, closed, low temperature (less than a 5°C) storage.