Name | Testosterone Undecanoate |
Synonyms | Andriol andriol TESTOSTERONE UNDECANOATE Testosterone Undecanoate TESTOSTERONE UNDECANOILATE testosterone,undecanoate(ester) 3-oxoandrost-4-en-17-yl undecanoate 4-ANDROSTEN-17-BETA-OL-3-ONE UNDECANOATE 17-[(1-oxoundecyl)oxy]-androst-4-en-3-one 4-ANDROSTEN-17BETA-OL-3-ONE 17-UNDECANOATE (17beta)-3-oxoandrost-4-en-17-yl undecanoate 17-beta-hydroxy-5-alpha-androstan-3-onundecanoate |
CAS | 5949-44-0 |
EINECS | 227-712-6 |
InChI | InChI=1/C30H48O3/c1-4-5-6-7-8-9-10-11-12-28(32)33-27-16-15-25-24-14-13-22-21-23(31)17-19-29(22,2)26(24)18-20-30(25,27)3/h21,24-27H,4-20H2,1-3H3 |
Molecular Formula | C30H48O3 |
Molar Mass | 456.71 |
Density | 1.03±0.1 g/cm3(Predicted) |
Melting Point | 59-61°C |
Boling Point | 550.7±50.0 °C(Predicted) |
Flash Point | 230.285°C |
Vapor Presure | 0mmHg at 25°C |
Storage Condition | Controlled Substance, -20°C Freezer |
Refractive Index | 1.522 |
Use | Male hormone drugs for male sexual dysfunction, aplastic anemia, etc |
This product is 17b-hydroxyandrostene-4-en-3-one 11-alkanoic acid. The content of C30H4803 shall be 97.0% ~ 103.0% based on the dry product.
The melting point of this product (General 0612) is 60~63°C.
take this product, precision weighing, and two oxygen six ring dissolved and quantitative dilution of each 1 ml containing about 14mg of solution, according to the law (General 0621), the specific rotation was 68 ° to 72 °.
take this product, dissolve and dilute with mobile phase to make a solution containing about 2mg per 1ml as a test solution; Take 1ml for precision measurement and put it in a 50ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. Except that the mobile phase is acetonitrile-isopropanol-water (40:40:20), 20ul of the test solution and the control solution are accurately measured according to the chromatographic conditions under the content determination item, human liquid chromatograph was injected respectively, and the chromatogram was recorded to 3 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 0.25 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 (2.0%). The peaks in the chromatogram of the test solution which were 0.02 times smaller than the main peak area of the control solution were ignored.
take this product, with phosphorus pentoxide as desiccant, under reduced pressure drying to constant weight, weight loss should not exceed 0.5% (General rule 0831).
measured by high performance liquid chromatography (General 0512).
silica gel bonded with eighteen alkyl silane was used as a filler; Acetonitrile-isopropanol-water (43:43:14) was used as a mobile phase; The detection wavelength was 240nm. The number of theoretical plates is not less than 4000 as calculated from the peak of testosterone 11.
take this product, precision weighing, adding methanol to dissolve and quantitatively dilute to make a solution containing about 0.5mg per lml, as a test solution, take 10u1 injection of human liquid chromatograph for precision measurement, record the chromatogram; Another testosterone 11 acid reference substance was determined by the same method. According to the external standard method to calculate the peak area, that is.
androgens.
light shielding, sealed storage.
This product contains testosterone 11 (C3()H4803) should be labeled the amount of 90.0% ~ 110.0%.
The content of this product is light yellow to light brown yellow oily liquid.
should comply with the relevant provisions under the capsule (General rule 0103).
take the contents under the difference of loading amount, mix evenly, weigh an appropriate amount (about 50mg equivalent to testosterone 11) accurately, put it in a 100ml measuring flask, add methanol to dissolve and dilute to the scale, shake well, filter, take the continued filtrate as a test solution, take 10M1 precision, according to the method under the item of testosterone 11 acid content determination, that is obtained.
Same as testosterone 11.
40mg
light shielding, sealed storage.
This product is a sterile oil solution of testosterone 11. The content of testosterone 11 (C30H48O3) shall be 90.0% to 110.0% of the labeled amount.
This product is an almost colorless to yellowish clear oily liquid.
take an appropriate amount of this product (about 125mg equivalent to testosterone 11/0) with a volume pipette, put it in a 50ml measuring flask, wash the inner wall of the pipette with diethyl ether for several times, wash the liquid and put it in the measuring flask, dilute with diethyl ether to the scale, shake, Take 5ml accurately, put it in a 10ml plug centrifuge tube, volatilize the diethyl ether in a warm water bath; Shake and extract with methanol for 4 times (5ml, 5ml, 5ml, 3ml), shake for 10 minutes each time and then centrifuge for 15 minutes, combine the methanol extract, put it in a 25ml measuring flask, dilute to the scale with methanol, shake well, as a test solution, from the "precision amount of 10M1 injection liquid chromatography", according to the method under the determination of testosterone 11 acid content, it is obtained.
Same as testosterone 11
2ml : 0.25g
light shielding, closed storage.
Overview | Testosterone undecanoate, also known as Andio; Antel; Undecanone; Testosterone undecanate; Testosterone undecanate; An Xiong; Testosterone undecanonate, is an androgenic drug, is an undecanate of testosterone, is a derivative of testosterone. It has an exciting effect on normal hematopoiesis, can promote the production of erythropoietin and enhance its effect, and also has a direct stimulating effect on erythroid progenitor cells. Testosterone replacement therapy for male sexual dysfunction, such as after orchiectomy, anorchidism, endocrine impotence, hypopituitarism, male middle-aged and elderly symptoms (such as loss of libido, mental and physical strength) and due to spermatogenesis Certain infertility caused by disorders. It can also be used for osteoporosis caused by androgen deficiency. |
pharmacological action | this product is a androgenic drug, an undecanoate of testosterone, and a derivative of testosterone. It can promote male growth, the development of male secondary sex signs and the structure of testis and accessory gonads, promote protein synthesis, reduce decomposition, enhance immune function, promote bone growth, promote erythropoiesis, feedback inhibit gonadotropin secretion, Inhibit estrogen secretion. |
pharmacokinetics | this product has rapid oral absorption, strong first pass metabolism and low bioavailability. The peak time of serum after oral administration has obvious individual differences, with an average of about 4 hours. After continuous administration, the serum testosterone level gradually increases and reaches a steady state in 2 to 3 weeks. After a single dose of intramuscular injection, the peak time of serum testosterone was on the 7th day and returned to the pre-intramuscular level after 21 days. |
indications | 1. primary or secondary testicular hypofunction; 2. delayed puberty in boys; 3. palliative treatment of female patients with breast cancer metastasis; 4. aplastic anemia; 5. rheumatoid arthritis; 6. male hormone deficiency syndrome in middle-aged and old people. |
adverse reactions | 1. hirsutism, acne, priapism, sperm reduction, semen volume reduction, water and sodium retention. 2. precocious puberty or epiphysis closure in prepubertal boys. 3. Occasionally gastrointestinal discomfort or allergic reaction. |
taboo | 1. those who are allergic to this product are prohibited. 2. Prostate cancer, breast cancer patients and suspicious persons, pregnant and lactating women are contraindicated. |
precautions | 1. when serious adverse reactions occur, treatment should be stopped immediately, and after the symptoms disappear, start again from a lower dose. 2. Patients with heart failure (including asymptomatic type), renal failure, prostatic hypertrophy, hypertension, epilepsy or trigeminal neuralgia (or those with a history of the above diseases) should be used with caution and closely observed. Androgen may cause water and sodium retention. 3. Prepubertal boys should be used with caution to avoid premature epiphysis closure or precocious puberty. 4. patients with kidney disease and heart disease with edema tendency should be used with caution. 5. This medicine must be swallowed in the whole pill and not chewed. |
drug interaction | 1. when combined with cyclosporine, cyclosporine toxicity is enhanced, causing kidney damage, cholestasis, paresthesia and other adverse reactions, which should be avoided. 2. Combined with adrenal cortex hormone, it can aggravate edema. 3. Combined with oral anticoagulants, the risk of bleeding increases. 4. Combined with barbiturates, the metabolism of this drug can be accelerated and the curative effect can be reduced. 5. Combined with prasestosterone, it produces synergistic androgen effect, which can cause liver toxicity. 6. Combined with Angelica sinensis, inhibit the metabolism of this drug, increase its androgen effect and the incidence of adverse reactions. 7. the application of this drug in diabetic patients can reduce blood sugar, so the dosage of insulin should be reduced. 8. when combined with paclitaxel, it can inhibit the metabolism of paclitaxel and lead to enhanced toxicity. |
usage and dosage | 1. oral administration: the initial dose is 120-160mg per day, and after 2-3 weeks of continuous administration, the dose is 40-120mg per day. Swallow twice in the morning and evening after meals. If you take an odd number of capsules every day, you can take one more capsule in the morning. 2. Injection: 250mg each time, once a month, the course of treatment is 4-6 months. If used in patients with aplastic anemia, it can also be increased to 500mg each time. |
main reference materials | [1] Chen Shaoping, Chen Zhuohui, Chen Peizhu editor-in-chief. Handbook of Oral Clinical Drugs. Guangzhou: South China University of Technology Press. 2005. [2] Xu Jingfeng, editor-in-chief Yang Benming. Manual of Clinical Prescription Drugs. Nanjing: Jiangsu Science and Technology Press. 2009. Page 204. [3] Editor-in-Chief Chen Jisheng. New clinical pharmacology. Beijing: China Traditional Chinese Medicine Press. 2013. |
use | male hormone drugs are used for male sexual dysfunction, aplastic anemia, etc. |