Testosterone Undecanoate
Testosterone Undecanoate
CAS: 5949-44-0
Molecular Formula: C30H48O3
Testosterone Undecanoate - Names and Identifiers
| 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 |
Testosterone Undecanoate - Physico-chemical Properties
| 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 |
Testosterone Undecanoate - Standard
Authoritative Data Verified Data
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.
Last Update：2024-01-02 23:10:35
Testosterone Undecanoate - Trait
Authoritative Data Verified Data
- This product is white crystal or crystalline powder; Odorless.
- This product is very soluble in chloroform, dissolved in ethanol, slightly soluble in methanol, vegetable oil, insoluble in water.
melting point
The melting point of this product (General 0612) is 60~63°C.
specific rotation
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 °.
Last Update：2022-01-01 11:30:25
Testosterone Undecanoate - Differential diagnosis
Authoritative Data Verified Data
- take about 5mg of this product, add sulfuric acid-ethanol (2:l ) lml to dissolve, that is, yellow with yellow-green fluorescence.
- 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 584).
Last Update：2022-01-01 11:30:26
Testosterone Undecanoate - Exam
Authoritative Data Verified Data
Related substances
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.
loss on drying
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).
Last Update：2022-01-01 11:30:27
Testosterone Undecanoate - 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 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.
assay
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.
Last Update：2022-01-01 11:30:27
Testosterone Undecanoate - Category
Authoritative Data Verified Data
androgens.
Last Update：2022-01-01 11:30:27
Testosterone Undecanoate - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 11:30:28
Testosterone Undecanoate - Andriol Testocaps（Testosterone Undecanoate Soft Capsules）
Authoritative Data Verified Data
This product contains testosterone 11 (C3()H4803) should be labeled the amount of 90.0% ~ 110.0%.
trait
The content of this product is light yellow to light brown yellow oily liquid.
identification
- an appropriate amount of the content of this product (about equivalent to lOOmg of testosterone 11 acid) was taken, and 10ml of n-hexane was added to dissolve testosterone 11 acid, which was used as a test solution. In addition, a testosterone 11 acid control product was dissolved and diluted with n-hexane to prepare a solution containing about 10 mg per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb 5 u1 of each of the above two solutions, respectively point on the same silica gel G thin layer plate, with n-hexane-acetone (6:1) as the developing solvent, it was developed, dried, and sprayed with 2, 4-dinitrophenylhydrazine solution to develop color. The position and color of the main spot displayed by the test solution should be the same as that of the reference solution.
- 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 the content of this product (about 20mg equivalent to testosterone 11), add methanol to dissolve testosterone 11 and dilute it to make a solution containing about 10mg per 1 ml, there is an absorption maximum at a wavelength of 0401 nm as determined by UV-Vis spectrophotometry (general).
- two items (1) and (2) above can be selected as one item.
examination
should comply with the relevant provisions under the capsule (General rule 0103).
Content determination
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.
category
Same as testosterone 11.
specification
40mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:30:29
Testosterone Undecanoate - Testosterone 11/1 injection
Authoritative Data Verified Data
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.
trait
This product is an almost colorless to yellowish clear oily liquid.
identification
- take 1 drop of this product, add 1 ml of sulfuric acid-ethanol (2:1) solution, shake well, then show yellow with yellow-green fluorescence.
- take an appropriate amount of this product (about equivalent to testosterone 11 acid lOOmg), add 10ml of n-hexane, shake, as a test solution; Take testosterone 11 Acid Control, A solution containing about 10mg per 1 ml was prepared by dissolving and diluting with n-hexane as a control solution. According to the thin layer chromatography (General 0502) test, absorb 5 u1 of each of the above two solutions, respectively point on the same silica gel G thin layer plate, with n-hexane-acetone (6:1) as the developing solvent, expand, dry, spray with 2, 4-dinitrophenylhydrazine test solution to make color, the position and color of the main spot of the test solution should be the same as the main spot of the reference solution.
- 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.
- two items (2) and (3) above can be selected as one item.
examination
- the relevant substances should be accurately measured with the internal volume pipette. Take an appropriate amount of this product (about 250mg equivalent to testosterone 11/0) and put it in a 25ml measuring flask, dilute with diethyl ether to the scale, shake, Take 5ml, put it in a 10ml plug centrifuge tube, volatilize the diethyl ether in a warm water bath; Shake it with methanol for 4 times (5ml, 5ml 5ml, 3ml), shake for 10 minutes each time, centrifuge for 15 minutes, combine methanol extract, put in 25ml measuring flask, dilute to the scale with methanol, shake well, as a test solution; precision lml, 50ml flask, diluted with methanol to the scale, shake, as a control solution. Test of the method under the feeding of related substances of testosterone 11. If there are impurity peaks in the chromatogram of the test solution, the peak of the auxiliary material before the retention time of the relative main peak of 0.3 is subtracted, and the area of the single impurity peak shall not exceed 0.25 times (0.5%) of the area of the main peak of the control solution, the sum of the area of each impurity bee 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.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
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.
category
Same as testosterone 11
specification
2ml : 0.25g
storage
light shielding, closed storage.
Last Update：2022-01-01 11:30:30
Testosterone Undecanoate - Reference Information
| 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. |
Last Update：2024-04-09 15:16:46
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Product Name: Testosterone Undecanoate Request for quotationCAS: 5949-44-0
Tel: +86-17551318830
Email: r@reformchem.com
Mobile: +86-17551318830
QQ: 3785839865
Product Name: Testosterone Undecanoate Request for quotation
CAS: 5949-44-0
Tel: 17505222756
Email: pules.cn@gmail.com
Mobile: +86-17551318830
Wechat: 17505222756
CAS: 5949-44-0
Tel: 17505222756
Email: pules.cn@gmail.com
Mobile: +86-17551318830
Wechat: 17505222756
Product Name: Testosterone undecanoate Request for quotation
CAS: 5949-44-0
Tel: +86-21-56795779
Email: charles7788@worldyachem.com
Mobile: +86-13651600618
QQ: 2850607228
Wechat: 13651600618
WhatsApp: +8613651600618
CAS: 5949-44-0
Tel: +86-21-56795779
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