Molecular Formula | C27H44O2 |
Molar Mass | 400.64 |
Density | 1.01±0.1 g/cm3(Predicted) |
Melting Point | 134-136°C |
Boling Point | 531.5±50.0 °C(Predicted) |
Flash Point | 222.6°C |
Solubility | Practically insoluble in water, freely soluble in ethanol (96 per cent), soluble in fatty oils. |
Vapor Presure | 1.62E-13mmHg at 25°C |
Appearance | White crystalline solid |
Maximum wavelength(λmax) | 264nm(Diethyl ether)(lit.) |
Merck | 14,4819 |
pKa | 14.43±0.40(Predicted) |
Storage Condition | −20°C |
Refractive Index | 1.534 |
MDL | MFCD00868328 |
Use | For the treatment of osteoporosis, vitamin D-dependent rickets and osteomalacia |
Risk Codes | R26/27/28 - Very toxic by inhalation, in contact with skin and if swallowed. R36/37/38 - Irritating to eyes, respiratory system and skin. |
Safety Description | S28 - After contact with skin, wash immediately with plenty of soap-suds. S36/37 - Wear suitable protective clothing and gloves. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36 - Wear suitable protective clothing. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. |
UN IDs | UN 2811 6.1/PG 1 |
WGK Germany | 3 |
RTECS | VS2851000 |
FLUKA BRAND F CODES | 8-10 |
HS Code | 29361000 |
Hazard Class | 6.1(a) |
Packing Group | I |
This product is (5Z,7E)-9, 10-ring-opening cholestere-5, 7,10(19)-triene-1a, 3B-diol. The content of C27H4402 shall be 97.5% ~ 102.0%.
The melting point of this product (General rule 0612) is 137~142°C, and it is decomposed at the same time during melting.
take this product, precision weighing, plus absolute ethanol dissolution and quantitative dilution to make a solution containing about 0621 mg per lml, determination according to law (general rule), the specific rotation was 46.0 ° to 52.0 °.
take this product, precision weighing, plus absolute ethanol dissolution and quantitative dilution to prepare about 10ug solution per lml, according to UV-visible spectrophotometry (General 0401 ), the absorbance was measured at a wavelength of 265nm, and the absorption coefficient was 420 to 447.
Related substances take this product, add mobile phase to dissolve and dilute to make about 0.1 mg of the solution was used as a test solution; 1ml was accurately weighed into a 100ml measuring flask, diluted to the scale with the mobile phase, and shaken to obtain a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution and the control solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded to 2 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, except for the former alfacalcidol peak, the area of a single impurity peak shall not be greater than 0.5 times (0.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
measured by high performance liquid chromatography (General 0512).
silica gel was used as a filler; Petroleum ether (60-90 ° C.)-ethyl acetate-chloroform (44:42:14) was used as a mobile phase; The detection wavelength was 265nm. Alfacalcidol was taken, dissolved and diluted with mobile phase to make about 0.lmg solution, under sunlight or tungsten light irradiation for 0.5 hours, take 20u1 injection human liquid chromatography, record chromatogram, relative retention time of trans alfacalcidol peak relative to alfacalcidol peak is about 0.92, the resolution of alfacalcidol peak and trans-alfacalcidol peak shall be in accordance with the requirements; 2ml of the above solution shall be taken separately, heated and refluxed in a water bath at 80°C for 2 hours, and allowed to cool, the relative retention time of the former alfacalcidol peak to the former alfacalcidol peak is about 1.3, and the degree of separation between the former alfacalcidol peak and the former alfacalcidol peak should meet the requirements. The number of theoretical plates is not less than 2000 based on the peak of alfacalcidol.
take this product, precision weighing, adding mobile phase to dissolve and quantitatively dilute to make a solution containing about lug per lml, as a test solution, take 20ml of precision volume and inject human liquid chromatograph, the chromatogram was recorded; The alfacalcidol reference substance was taken and determined by the same method. According to the external standard method to calculate the peak area, that is.
calcium metabolism regulator.
shading, nitrogen filling, sealing, storage in cold place.
This product contains alfacalcidol (C27H4402) should be labeled the amount of 85.0% ~ 115.0%.
This product is white tablet.
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.
Take 20 tablets of this product, precision weighing, fine, precision weighing an appropriate amount (about 1ug equivalent to alfacalcidol), put it in a plug centrifuge tube, Precision Plus mobile phase-dichloromethane (1:l)2ml, the vortex and ultrasonic treatment were performed for 4 minutes, and the alfacalcidol was dissolved, and the high speed centrifugation was carried out. The supernatant was taken as a test solution, and the measurement was carried out according to the method under the item of measuring the content of alfacalcidol.
with alfacalcidol.
(1)0.25ug(2)0.5ug
light shielding, sealing, and storage in a dry, cool and dark place.
This product is made of alfacalcidol plus refined edible vegetable oil and suitable antioxidant, containing alfacalcidol (C27H4402) should be 90.0% ~ 120.0% of the label amount.
The content of this product is light yellow to deep yellow oily liquid.
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 the capsule (General rule 0103).
with alfacalcidol.
(1)0.25ug(2)0.5ug
It was shielded from light, sealed, and stored in a cool-dark dry place.