Name | Etretin |
Synonyms | Etretin acitretin ACITRETIN Soriatane SORIATANE Neotigason Acritretin NEOTIGASON Neotigason, Soriatane 9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid (all-e)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraen (ALL-E)-9-(4-METHOXY-2,3,6-TRIMETHYLPHENYL)-3,7-DIMETHYL-2,4,6,8-NONATETRAENOIC ACID (2Z,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid |
CAS | 55079-83-9 |
EINECS | 259-474-4 |
InChI | InChI=1/C21H26O3/c1-14(8-7-9-15(2)12-21(22)23)10-11-19-16(3)13-20(24-6)18(5)17(19)4/h7-13H,1-6H3,(H,22,23)/b9-7+,11-10+,14-8+,15-12- |
Molecular Formula | C21H26O3 |
Molar Mass | 326.43 |
Density | 1.1348 (rough estimate) |
Melting Point | 228-230°C |
Boling Point | 404.46°C (rough estimate) |
Flash Point | 180.3°C |
Solubility | Almost insoluble in water, soluble in tetrahydrofuran, slightly soluble in acetone and ethanol (96%), very slightly soluble in cyclohexane |
Vapor Presure | 1.08E-11mmHg at 25°C |
Appearance | powder |
Maximum wavelength(λmax) | ['352nm(MeOH)(lit.)'] |
Merck | 14,112 |
pKa | 4.72±0.33(Predicted) |
Storage Condition | -20°C |
Stability | LIGHT SENSITIVE |
Sensitive | Photosensitivity |
Refractive Index | 1.4700 (estimate) |
MDL | MFCD00866632 |
Physical and Chemical Properties | Crystallization from hexane, melting point 228-230 °c. Acute toxicity LD50 mice by intraperitoneal injection (mg/kg):>4000(1 day),700(10 days),700(20 days). |
Use | For the treatment of psoriasis and other intractable skin diseases |
Risk Codes | R61 - May cause harm to the unborn child R36/38 - Irritating to eyes and skin. R50/53 - Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. |
Safety Description | S53 - Avoid exposure - obtain special instructions before use. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S60 - This material and its container must be disposed of as hazardous waste. S61 - Avoid release to the environment. Refer to special instructions / safety data sheets. S37/39 - Wear suitable gloves and eye/face protection |
UN IDs | UN 3077 9/PG 3 |
WGK Germany | 3 |
RTECS | RA8460000 |
FLUKA BRAND F CODES | 8-10-21 |
HS Code | 2918992090 |
Hazard Class | 9 |
Packing Group | III |
Toxicity | LD50 i.p. in mice (mg/kg): >4000 (1 day), 700 (10 days), 700 (20 days) (Bollag, 1978) |
This product is all-trans -9-(4-methoxy-2, 3, 6-trimethylphenyl)-3, 7-dimethyl-2, 4,6, 8-nontetraenoic acid. The content of C21H2603 shall be between 98.5% and 102.0% based on the dry product.
operation in the dark. Take an appropriate amount of this product, precision weigh, add about 5ml of tetrahydrofuran to dissolve, quantitatively dilute with methanol to make a solution containing 0.25mg of acitretin a per 1 ml as the test solution; Take an appropriate amount of precision, A solution containing 0.25ug of acitretin a per 1 ml was prepared by dilution with methanol and used as a control solution; 13-cis-acitretin a (impurity I), 9-cis-acitretin a (impurity II). With 13-ethyl acitretin a (impurity III) each appropriate amount of reference, precision weighing, and tetrahydrofuran about 5ml after dissolving, quantitative dilution with methanol to make each 1 ml containing impurities I 0.75ug, the solution of impurity III 0.5ug and impurity III 1.0ug shall be used as the reference solution; In addition, appropriate amounts of the reference products of impurity I, 11-cis-acitretin a (impurity IV), acitretin A, impurity II and impurity III shall be taken, after about 5ml of tetrahydrofuran is added and dissolved, the mixture is diluted with methanol to give a content of impurity I 0.75ug, impurity IV 0.5ug, avermectin a 250ug, impurity II 0.5ug and impurity III l per 1 ml. Oug's solution, as a system-suitable solution. The test shall be carried out according to the method under determination of inclusion of director, and the system applicable solution 20u1 shall be injected into the liquid chromatograph, and the chromatogram shall be recorded. The number of theoretical plates shall not be less than 5000 based on avermectin a peak, the degree of separation between adjacent chromatographic peaks shall meet the requirements. The control solution, the reference solution and the test solution were respectively injected with 20 u1, and the chromatogram was recorded to 2 times of the retention time of the main component peak. If the chromatographic peaks in the chromatogram of the test solution are consistent with the retention time of impurity I peak, impurity II peak and impurity III peak, the peak area shall not exceed 0.3%, 0.2% and 0.4% respectively according to the external standard method; the Peak area of other single unknown impurities shall not be greater than the main peak area of the control solution (0.1% ); The total amount of all impurities shall not exceed 1.0%.
take this product, at 60°C under reduced pressure drying to constant weight, weight loss should not exceed 0.5% (General rule 0831).
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
measured by high performance liquid chromatography (General 0512).
silica gel bonded with eighteen alkyl silane was used as the filler; Methanol-0.5% acetic acid solution (83:17) was used as the mobile phase; The injection temperature was the detection wavelength of 360nm. The theoretical plate number is not less than 3000 based on the acitretin a peak.
operation in the dark. Take about 25mg of this product, precision weighing, add about 5ml of tetrahydrofuran, shake to dissolve, dilute with methanol to make a solution containing about 50ug of acitretin a per 1 ml, 20u1 was injected into the liquid chromatograph accurately, and the chromatogram was recorded. An appropriate amount of acitretin a reference substance was taken and determined by the same method, and the peak area was calculated according to the external standard method.
antikeratotic agents.
sealed and kept in cool and dark place.
This product contains avermectin a (C21H2603) should be 90.0% ~ 110.0% of the label amount.
The content of this product is yellow granules or powder.
operation in the dark. Take 20 capsules of this product, precision weighing, calculate the average loading. Take the contents, mix well, weigh an appropriate amount accurately, add about 5ml of N,N-dimethylformamide to dissolve acitretin A, and dilute with anhydrous ethyl yeast to make a solution containing about 5ug of acitretin a per 1 ml, shake, filter, take the continued filtrate as a test solution, take 20ul of precision, according to the method under the determination of the content of acitretin A, obtained.
Same as Avi
(l)10mg (2)25mg
shade, seal, and store in a cool place.