Triamcinolone acetonide
Triamcinolone acetonide
CAS: 76-25-5
Molecular Formula: C24H31FO6
Triamcinolone acetonide - Names and Identifiers
Triamcinolone acetonide - Physico-chemical Properties
| Molecular Formula | C24H31FO6 |
| Molar Mass | 434.5 |
| Density | 1.1517 (estimate) |
| Melting Point | 274-278°C (dec.) |
| Boling Point | 576.9±50.0 °C(Predicted) |
| Specific Rotation(α) | D23 +109° (c = 0.75 in chloroform) |
| Flash Point | 302.7°C |
| Water Solubility | Soluble in DMSO or ethanol. Slightly soluble in water. |
| Solubility | Very slightly soluble in water, slightly soluble in ethanol, soluble in chloroform, slightly soluble in acetone. |
| Vapor Presure | 1.04E-15mmHg at 25°C |
| Appearance | White to off-white crystalline powder |
| Color | White to Off-White |
| Merck | 9596 |
| pKa | 12.87±0.10(Predicted) |
| Storage Condition | Refrigerator |
| Stability | Combustible. Incompatible with strong oxidizing agents. |
| Refractive Index | 1.5980 (estimate) |
| MDL | MFCD00056834 |
| Use | For the adrenal cortex hormone drugs, for neurodermatitis, eczema, psoriasis, Arthralgia, bronchial asthma and other diseases |
Triamcinolone acetonide - Risk and Safety
| Hazard Symbols | T - Toxic |
| Risk Codes | 61 - May cause harm to the unborn child |
| Safety Description | S53 - Avoid exposure - obtain special instructions before use. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) |
| WGK Germany | 3 |
| RTECS | TU3920000 |
| TSCA | Yes |
| HS Code | 29372290 |
| Toxicity | LD50 oral in mouse: 5gm/kg |
Triamcinolone acetonide - Standard
Authoritative Data Verified Data
This product is 9-fluoro-11b, 21-dihydroxy-16a, 17[(1-methylethylidene) BIS (OXY)]-pregnan-1, 4-dien-3, 20-dione. The content of C24H31F06 shall be between 97.0% and 102.0% based on the dry product.
Last Update：2024-01-02 23:10:35
Triamcinolone acetonide - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Odorless.
- This product is dissolved in acetone, slightly soluble in chloroform, slightly soluble in methanol or ethanol, and slightly soluble in water.
specific rotation
take this product, precision weighing, plus dioxane dissolution and quantitative dilution of about 10 mg per lml solution, according to the law (General 0621), the specific rotation was 101 ° to 107 °.
absorption coefficient
take this product, precision weighing, plus ethanol dissolution and quantitative dilution to make a solution containing about 10ug per lml, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 239nm, and the absorption coefficient was 340 to 370.
Last Update：2022-01-01 11:44:54
Triamcinolone acetonide - Differential diagnosis
Authoritative Data Verified Data
- 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 control (Spectrum set 603).
Last Update：2022-01-01 11:44:55
Triamcinolone acetonide - Exam
Authoritative Data Verified Data
fluorine
take this product, check according to law (General 0805), fluorine content should be 4.0% ~ 4.75%.
Related substances
take about 25mg of this product, put it in a 50ml measuring flask, add 35ml of methanol, shake to dissolve, dilute with water to the scale, shake well, as a test solution; take 1ml accurately, put it in a 70% measuring flask, add methanol solution to dilute to the scale, shake, as a control solution. 20 u1 of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 3.5 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.3 times (0.3%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 0.8 times (0.8%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which were 0.01 times smaller than the main peak area of the control solution were ignored.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 1.5% (General rule 0831).
ignition residue
not more than 0.2% (General rule 0841).
selenium
take this product 0.10g, inspection according to law (General 0804), should meet the requirements (0.005%).
Last Update：2022-01-01 11:44:55
Triamcinolone acetonide - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane was used as the filler; Methanol-water (525:475) was used as the mobile phase; The detection wavelength was 240nm. Triamcinolone acetonide and triamcinolone were dissolved and diluted with 70% methanol solution to prepare 5ug solutions each in 1 ml. 20u1 was injected into human liquid chromatograph and the chromatogram was recorded, the number of theoretical plates shall not be less than 5000 calculated by triamcinolone acetonide peak, and the separation degree between triamcinolone acetonide peak and triamcinolone acetonide peak shall be greater than 15.
assay
take this product, precision weighing, adding methanol to dissolve and quantitatively dilute to make a solution containing about 30ug per lml, as a test solution, take 20u1 injection of human liquid chromatograph for precision measurement, record the chromatogram; Another triamcinolone acetonide reference substance, the same method for determination. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 11:44:56
Triamcinolone acetonide - Category
Authoritative Data Verified Data
adrenocortical hormone drugs.
Last Update：2022-01-01 11:44:56
Triamcinolone acetonide - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 11:44:56
Triamcinolone acetonide - Triamcinolone Acetonide Injection
Authoritative Data Verified Data
This product is a sterile suspension of triamcinolone acetonide. Triamcinolone acetonide-containing (C24H31F06) shall be between 90.0% and 110.0% of the labeled amount.
trait
This product is a suspension of fine particles. After standing, the fine particles sink and form a uniform Milky White suspension after shaking.
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 reference solution.
- take an appropriate amount of this product (about 50mg equivalent to triamcinolone acetonide), extract with diethyl ether for 2 times, 10ml each time, discard the diethyl ether, separate the water layer, filter, and wash the residue with a small amount of water, dry at 105°C for 1 hour. The dried residue was dissolved in absolute ethanol and diluted to give a solution containing about 12ug per 1 ml, and the absorption maximum was measured by UV-Vis spectrophotometry (General 0401) at a wavelength of Nm.
- take an appropriate amount of this product (about 40mg equivalent to triamcinolone acetonide), add 5ml of water, add 10ml of diethyl ether, shake extraction, take the water layer, water bath to dry, the residue is dried under reduced pressure, and determined according to law. The infrared absorption spectrum of this product should be consistent with the spectrum of the control (Spectrum set 603 figure).
examination
- the pH value should be 5.0 to 7.5 (General 0631).
- Related substances take this product, shake, take 5ml accurately, put it in a 200ml measuring flask, add an appropriate amount of mobile phase, shake to dissolve triamcinolone acetonide, dilute it to scale with mobile phase, shake well, after filtration, the secondary filtrate was taken as a test solution. Test according to the method under triamcinolone acetonide related substances. If there are impurity peaks in the chromatogram of the test solution, 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 1.5 times (1.5%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which were 0.01 times smaller than the main peak area of the control solution were ignored.
- particle size take this product, fully shake, take 1 drop, according to particle size determination method (General 0982 first method) check 3 visual field, particles should be less than 15um, the particles below 5mm shall not be less than 70%, and the particles below 10um shall not be less than 97%.
- the bacterial endotoxin of this product is taken and checked according to law (General rule 1143). The amount of endotoxin per 1 mg of triamcinolone acetonide should be less than 3.0EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take this product, shake, take 2ml, put it in 50ml measuring flask, add the appropriate amount of methanol, ultrasonic dissolve triamcinolone acetonide, let it cool, dilute it to scale with methanol, shake it well, after filtration, an appropriate amount of the filtrate was accurately taken and quantitatively diluted with methanol to prepare a solution containing about 30ug per 1 ml as a test solution. According to triamcinolone acetonide content determination method under the item of determination, calculation, that is obtained.
category
Same as triamcinolone acetonide.
specification
(l)lml:40mg (2)2ml:80mg
storage
light shielding, closed storage.
Last Update：2022-01-01 11:44:57
Triamcinolone acetonide - Triamcinolone Acetonide and Econazole Nitrate Cream
Authoritative Data Verified Data
This product contains triamcinolone acetonide (C24H31F06) should be 90.0% ~ 115.0% of the label amount; Containing econazole nitrate (C18H15C13N20 • HNO3) should be 90.0% ~ 110.0% of the label amount.
trait
This product is white cream.
identification
- take about 2g of this product, add 18ml of acetone, shake for 15 minutes, filter, take the filtrate as the test solution; Take the appropriate amount of triamcinolone acetonide and econazole nitrate, triamcinolone acetonide in 1 ml was prepared by adding acetone respectively. A solution of 1 mg and 1 mg of econazole nitrate was used as the Control Solutions (1) and (2). According to the thin layer chromatography (General 0502) test, absorb the above three solutions of 10 u1, respectively, on the same silica gel GF254 thin layer plate, with toluene-ethanol-ethyl acetate-formic acid (55:20:20:5) for the development of the solvent, expand, dry, first set the UV lamp (254nm) under the inspection, then set the saturated iodine vapor in the color, the position and color of the two principal component spots displayed by the test solution should be the same as that of the control solution.
- 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 two main peaks of the control solution.
- two items (1) and (2) above can be selected as one item.
examination
should comply with the relevant provisions under the term "milk aids" (chapter 0109).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using octyl silane bonded silica gel as filler; [take 0.94g of sodium hexanesulfonate, add acetonitrile-isopropanol-water-85% Phosphoric acid (140:140:720:1) dissolved and diluted to 1000ml] as mobile phase A, [take sodium hexanesulfonate 0.94g, add methanol-water-85% Phosphoric acid (900:100:1) dissolve and dilute to 1000ml] as mobile Phase B, and perform gradient elution according to the following table; Column temperature is 40 ° C.; Detection wavelength is 227nm. The separation of triamcinolone acetonide peak and econazole peak should meet the requirements.
- determination method: take 1.25g of this product, weigh it accurately, put it in a 25ml measuring flask, add 2ml of tetrahydrofuran, shake for 1 min to dissolve triamcinolone acetonide and econazole nitrate, and dilute it to the scale with metronidazole, shake well, filter, take the continued filtrate as the test solution, take the continued filtrate 10 u1 accurately, inject human liquid chromatograph, record the chromatogram; Take the triamcinolone acetonide reference about 15.6mg, in a 25ml measuring flask, dissolve in methanol and dilute to the scale, shake well to be used as triamcinolone acetonide reference solution; Another econazole nitrate reference about 12.5mg, in a 25ml measuring flask, add 2ml of triamcinolone acetonide reference solution and 2ml of tetrahydrofuran, dilute with methanol to scale, shake well, measure with the same method, and calculate with peak area according to external standard method.
category
antifungal drugs.
storage
sealed and stored in a cool place.
Last Update：2022-01-01 11:44:58
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