1-hydroxycholecalciferol
alphacalcidol
CAS: 41294-56-8
Molecular Formula: C27H44O2
1-hydroxycholecalciferol - Names and Identifiers
1-hydroxycholecalciferol - Physico-chemical Properties
| 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 |
1-hydroxycholecalciferol - Risk and Safety
| 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 |
1-hydroxycholecalciferol - Standard
Authoritative Data Verified Data
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%.
Last Update：2024-01-02 23:10:35
1-hydroxycholecalciferol - Trait
Authoritative Data Verified Data
- This product is white crystalline powder; Odorless; Easy to deteriorate when exposed to light, humidity and heat.
- This product is soluble in ethanol or methylene chloride, soluble in ether, almost insoluble in water.
melting point
The melting point of this product (General rule 0612) is 137~142°C, and it is decomposed at the same time during melting.
specific rotation
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 °.
absorption coefficient
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.
Last Update：2022-01-01 12:00:35
1-hydroxycholecalciferol - Differential diagnosis
Authoritative Data Verified Data
- take about 0.02mg of this product, add 0.2ml of chloroform to dissolve, add 3 drops of acetic acid and 1 drop of sulfuric acid, shake, the initial yellow, instant red, gradually into yellow-green.
- 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 reference product (General rule 0402).
Last Update：2022-01-01 12:00:35
1-hydroxycholecalciferol - Exam
Authoritative Data Verified Data
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%).
Last Update：2022-01-01 12:00:36
1-hydroxycholecalciferol - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
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.
assay
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.
Last Update：2022-01-01 12:00:37
1-hydroxycholecalciferol - Category
Authoritative Data Verified Data
calcium metabolism regulator.
Last Update：2022-01-01 12:00:37
1-hydroxycholecalciferol - Storage
Authoritative Data Verified Data
shading, nitrogen filling, sealing, storage in cold place.
Last Update：2022-01-01 12:00:37
1-hydroxycholecalciferol - Bon-One (Alfacalcidol Tablets)
Authoritative Data Verified Data
This product contains alfacalcidol (C27H4402) should be labeled the amount of 85.0% ~ 115.0%.
trait
This product is white tablet.
identification
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.
examination
- Content uniformity: Take 1 tablet of this product, crush it in a centrifugal tube with a specific plug, precision add mobile phase-dichloromethane (1:l)lml, plug, vortex oscillation and ultrasonic treatment cross for 4 minutes, alfacalcidol was dissolved, centrifuged at high speed, and the content was measured according to the method under the content measurement item. The limit shall be ± 25% and shall be in accordance with the regulations (General rule 0941).
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
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.
category
with alfacalcidol.
specification
(1)0.25ug(2)0.5ug
storage
light shielding, sealing, and storage in a dry, cool and dark place.
Last Update：2022-01-01 12:00:38
1-hydroxycholecalciferol - Alfacalcidol Soft Capsules
Authoritative Data Verified Data
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.
trait
The content of this product is light yellow to deep yellow oily liquid.
identification
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.
examination
should comply with the relevant provisions under the capsule (General rule 0103).
Content determination
- light-shielding operation. Determined by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test silica gel was used as the filler; Petroleum ether (60-900 ethyl acetate-tetrahydrofuran (2:1:1) was used as the mobile phase; The detection wavelength was 265mn. Take alfacalcidol reference solution and irradiate under sunlight or tungsten light for 0.5 hours to produce a certain amount of trans alfacalcidol. Inject 20u1 into human liquid chromatograph, the relative retention time of the peak of trans-alfacalcidol relative to the peak of alfacalcidol is about 0.94, the degree of separation between the peak of alfacalcidol and the peak of trans-alfacalcidol should meet the requirements, and the tailing factor of the peak of alfacalcidol should be less than 1.5, the number of theoretical plates is not less than 2500 based on the peak of alfacalcidol.
- determination method 60 capsules (0.25ug specification) or 40 capsules (0.5ug specification) of this product were accurately weighed, the contents were poured out, and the capsule shell was washed with diethyl ether. The ether was purified, and the average weight of each content was determined by precision weighing. Mix the contents evenly, weigh the appropriate amount accurately, add the mobile phase to dissolve and quantitatively dilute to prepare the solution containing alfacalcidol lug per lml as the test solution, and inject 20u1 into human liquid chromatograph with precise amount, record the chromatogram; Take an appropriate amount of alfacalcidol reference substance, weigh it precisely, dissolve it with mobile phase and dilute it quantitatively to make a solution containing lug in every lml, and measure it with the same method. According to the external standard method to calculate the peak area, that is.
category
with alfacalcidol.
specification
(1)0.25ug(2)0.5ug
storage
It was shielded from light, sealed, and stored in a cool-dark dry place.
Last Update：2022-01-01 12:00:39
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