595-33-5
megestrol acetate
CAS: 595-33-5
Molecular Formula: C24H32O4
595-33-5 - Names and Identifiers
| Name | megestrol acetate |
| Synonyms | megestrol acetate Megesgtrol Acetate Megestrol Acetate (250 mg) * Megestrol acetate acetate 6-MethleneProgesterone Acetate Megestrol acetate, progesterone 3,20-dioxopregna-4,6-dien-17-yl acetate 17-Acetoxy-6-methylpregna-4,6-diene-3,20-dione 17-alpha-acetoxy-6-dehydro-6-methylprogesterone 6-methyl-3,20-dioxopregna-4,6-dien-17-yl acetate 17-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione 17-hydroxy-6-methylpregna-4,6-diene-3,20-dione 17-acetate |
| CAS | 595-33-5 |
| EINECS | 209-864-5 |
| InChI | InChI=1/C23H30O4/c1-14(24)23(27-15(2)25)12-9-20-18-6-5-16-13-17(26)7-10-21(16,3)19(18)8-11-22(20,23)4/h5-6,13,18-20H,7-12H2,1-4H3/t18-,19+,20+,21+,22+,23+/m1/s1 |
595-33-5 - Physico-chemical Properties
| Molecular Formula | C24H32O4 |
| Molar Mass | 384.51 |
| Density | 1.0474 (rough estimate) |
| Melting Point | 214°C |
| Boling Point | 431.17°C (rough estimate) |
| Specific Rotation(α) | D24 +5° (chloroform) |
| Flash Point | 218.7°C |
| Solubility | Practically insoluble in water, soluble in acetone, sparingly soluble in alcohol. |
| Vapor Presure | 2.59E-10mmHg at 25°C |
| Appearance | neat |
| Color | White |
| Merck | 14,5805 |
| BRN | 1917291 |
| Storage Condition | Sealed in dry,Room Temperature |
| Refractive Index | 11 ° (C=2, CHCl3) |
| MDL | MFCD00056470 |
| Physical and Chemical Properties | Melting Point: 214°C |
| In vitro study | Megestrolacetate inhibits the expression of cytoplasmic aromatase by nuclear C/EBPβ in the hippocampus of ischemic rats induced by reperfusion injury. Megestrol acetate significantly increased adipose-derived stem cell (ASCs) proliferation, migration, and adipogenic differentiation in a dose-dependent manner. In adipose stem cells (ASCs), megestrol acetate also upregulates genes downstream of the glucocorticoid receptor (GR). |
| In vivo study | Megestrol acetate significantly reduced circulating concentrations of estradiol (E2) and testosterone (T) in female fish and significantly reduced circulating concentrations of 11-ketostosterone (11-KT) in male fish. Megestrol acetate significantly downregulates transcription of specific genes along the hypothalamic-pituitary-gonadal (HPG) axis. In cats, megestrol acetate progressively worsens glucose tolerance, with a significant increase in mean fasting blood glucose concentration and a decrease in mean plasma glucose clearance at 6 and 12 months after treatment. In cats following ACTH stimulation, megestrol acetate also progressively decreased resting plasma cortisol concentrations and cortisol concentrations. Treatment with megestrol acetate(50 mg/kg/day) for 9 days significantly increased food and water intake compared to untreated controls. In the rat arcuate nucleus (where neuropeptide Y is synthesized), the lateral thalamic area (neurons through the arch), the medial preoptic area, the ventromedial nucleus, and the dorsomedial nucleus, megestrol acetate(50 mg/kg/day) significantly increased the concentration of neuropeptide Y (90-140%). |
595-33-5 - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R40 - Limited evidence of a carcinogenic effect R48 - Danger of serious damage to health by prolonged exposure |
| Safety Description | S22 - Do not breathe dust. S24/25 - Avoid contact with skin and eyes. |
| WGK Germany | 3 |
| RTECS | TU4075000 |
| HS Code | 29372390 |
| Toxicity | LD50 intravenous in mouse: 56mg/kg |
595-33-5 - Reference
| Reference Show more | 1. [IF=7.514] Suo Decheng et al."Trace analysis of progesterone and 21 progestins in milk by ultra-performance liquid chromatography coupled with high-field quadrupole-orbitrap high-resolution mass spectrometry."Food Chem. 2021 Nov;361:130115 |
595-33-5 - Compound Megestrol Acetate Tablets
Authoritative Data Verified Data
This product contains acetic acid (C24H3204) and ethinyl estradiol (C20H2402) should be 90.0% to 110.0% of the label amount.
prescription
megestrol acetate lg
Ethinylestradiol 0.035g
Appropriate amount of excipients
Made into 1000 tablets
trait
This product is a film-coated tablet, which shows internal color or similar internal color after removing the coating.
identification
- take 1 tablet of this product, grind, add anhydrous ethanol 5ml, grind for several minutes, filter, take the filtrate to dry in water bath, add sulfuric acid 1ml Dropwise to the residue, that is orange red.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks of the control solution.
examination
- Content uniformity 1 tablet of megestrol acetate and ethinylestradiol was dissolved by ultrasonic wave, placed in a test tube with a specific plug, and then centrifuged, the content of the supernatant was determined by the method under the content determination item. The limit of megestrol acetate was ± 15%, and the limit of ethinyl estradiol was ± 20%, which should be in accordance with the regulations (General 0941).
- dissolution: according to the dissolution and release determination method (General rule 0931 second method), 0.5% sodium dodecyl sulfate was used as the dissolution medium, and the rotation speed was 75 rpm, after 60 minutes, the appropriate amount of the solution was taken, filtered, and the filtrate was taken as the test solution. Determined by high performance liquid chromatography (General 0512). Ethyl acetate-water (60:40) was used as mobile phase. The detection wavelength of megestrol acetate was 288nm. Ethinyl estradiol was measured with a fluorescence detector at an excitation wavelength of 285nm and an emission wavelength of 310mn. The number of theoretical plates shall not be less than 2000 based on the peak of megestrol acetate. The sample solution was accurately weighed and injected into the liquid chromatograph to record the chromatogram. Another reference substance of megestrol acetate was accurately weighed, dissolved with methanol and quantitatively diluted to make the O content in each lml. lmg solution, as a reference stock solution (1); Take the ethinyl estradiol reference, precision weighing, add the appropriate amount of methanol, ultrasonic dissolution, cool, A solution containing 3.5ug per 1 ml was prepared by quantitative dilution and used as a reference stock solution (2). 2ml of each of the stock Solutions (1) and (2) of the reference substance were accurately weighed, placed in a 100ml measuring flask, diluted to a scale with a dissolution medium, and shaken to obtain a reference solution, which was measured by the same method. The dissolution amount of each tablet was calculated by the peak area according to the external standard method. Limits for megestrol acetate and ethinylestradiol are 75% of the labeled amount and should be met.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Acetonitrile-water (60:40) as mobile phase; The detection wavelength was 220nm. The number of theoretical plates shall not be less than 2000 based on the peak of megestrol acetate, and the separation degree of megestrol acetate peak and ethinyl estradiol peak shall meet the requirements.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 5mg equivalent to megestrol acetate), put it in a 50ml measuring flask, add an appropriate amount of mobile phase, the megestrol acetate and ethinyl estradiol were dissolved by ultrasound, allowed to cool, diluted to scale with mobile phase, shaken, centrifuged, and the supernatant was taken as the test solution, and 20u1 was injected into the liquid chromatograph in a precise amount, record the chromatogram; Take appropriate amounts of megestrol acetate and ethinyl estradiol respectively, weigh them precisely, dissolve them with mobile phase and dilute them quantitatively to make a solution containing megestrol acetate 100ug and ethinyl estradiol 3.5ug per 1 ml. According to the external standard method to calculate the peak area, that is.
category
birth control pills.
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:43:52
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