Okasa-mascul - Names and Identifiers
Name | Testosterone Propionate
|
Synonyms | TP Vulvan Testex Nasdol Oreton Orchiol Telipex Testrex Tostrin nsc9166 Enarmon Masenate Testoxyl Testodet Androlon NSC 9166 TP (VAN) Testogen Testosid Synerone Agovirin Homandren Testolets Uniteston CCRIS 575 Testodrin Propiokan Orchistin Solvotest Testormol Andronate Pantestin Synandrol Testaform Aquaviron AI3-26378 Andrusol-P Testonique Sterandryl Enarmon-oil Androtest P Hormoteston Androteston Primotestone DEA No. 4000 Okasa-Mascul Okasa-mascul Orchisterone Androsteston neo-Hombreol Bio-testiculina Oreton propionate Testosteroni propionas TESTOSTERONE PROPIONATE Testosterone Propionate Recthormone testosterone TESTOSTERON 17-PROPIONATE TESTOSTERONE 17-PROPIONATE Testosterone-17beta propionate Testosterone-17beta-propionate Testosterone-17-beta-propionate 3-oxoandrost-4-en-17-yl propanoate 17beta-(Propionyloxy)androst-4-en-3-one 17beta-Hydroxyandrost-4-en-3-one propionate 17beta-Hydroxy-4-androsten-3-one 17-propionate Androst-4-en-3-one, 17beta-hydroxy-, propionate delta(sup 4)-Androstene-17-beta-propionate-3-one Androst-4-en-3-one, 17-(1-oxopropoxy)-, (17beta)- 17beta-Hydroxyandrost-4-en-3-one-17beta-propionate (8xi,9xi,14xi,17beta)-3-oxoandrost-4-en-17-yl propanoate
|
CAS | 57-85-2
|
EINECS | 200-351-1 |
InChI | InChI=1/C22H32O3/c1-4-20(24)25-19-8-7-17-16-6-5-14-13-15(23)9-11-21(14,2)18(16)10-12-22(17,19)3/h13,16-19H,4-12H2,1-3H3/t16?,17?,18?,19-,21-,22-/m0/s1 |
InChIKey | PDMMFKSKQVNJMI-BLQWBTBKSA-N |
Okasa-mascul - Physico-chemical Properties
Molecular Formula | C22H32O3
|
Molar Mass | 344.5 |
Density | 1.0906 (rough estimate) |
Melting Point | 118-123°C |
Boling Point | 419.57°C (rough estimate) |
Specific Rotation(α) | D25 +83 to +90° (100 mg in 10 ml dioxane) |
Flash Point | 196.3°C |
Water Solubility | <0.1 g/100 mL at 24.5 ºC |
Solubility | This product is soluble in chloroform (50 mg/ml). |
Vapor Presure | 1.89E-08mmHg at 25°C |
Appearance | solid |
Color | white |
Merck | 13,9255 |
BRN | 3221760 |
Storage Condition | 2-8℃ |
Sensitive | Photo`sensitive` solid |
Refractive Index | 1.5000 (estimate) |
MDL | MFCD00003653 |
Physical and Chemical Properties | melting point 118°C water-soluble <0.1g/100 mL at 24.5°C
|
Use | For the treatment of breast cancer, ovarian cancer, uterine fibroids, multiple myeloma and kidney cancer |
Okasa-mascul - Risk and Safety
Hazard Symbols | T - Toxic
|
Risk Codes | R45 - May cause cancer
R22 - Harmful if swallowed
R63 - Possible risk of harm to the unborn child
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Safety Description | S53 - Avoid exposure - obtain special instructions before use.
S36/37 - Wear suitable protective clothing and gloves.
S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.)
|
UN IDs | 2811 |
WGK Germany | 3 |
RTECS | XA3115000 |
HS Code | 29372900 |
Toxicity | LD50 oral in rat: 1gm/kg |
Okasa-mascul - Introduction
Open Data Unverified Data
androgens, clinically applicable to the absence of testis, cryptorchidism, male hypogonadism; Gynecological diseases such as menorrhagia, uterine fibroids; Senile osteoporosis and aplastic anemia.
Last Update:2022-01-01 08:48:25
Okasa-mascul - Nature
Open Data Unverified Data
Last Update:2022-01-01 08:48:26
Okasa-mascul - Standard
Authoritative Data Verified Data
This product is 17 [hydroxyandrostin-4-diluted -3-ketone propionate. The content of C22H3203 shall be 97.0% ~ 103.0% based on the dry product.
Last Update:2024-01-02 23:10:35
Okasa-mascul - Trait
Authoritative Data Verified Data
- This product is white crystalline or white crystalline powder; Odorless.
- This product is easily soluble in chloroform, soluble in methanol, ethanol or ether, soluble in ethyl acetate, slightly soluble in vegetable oil, insoluble in water.
melting point
The melting point of this product (General 0612) is 118~123°C.
specific rotation
take this product, precision weighing, plus ethanol dissolution and quantitative dilution of about 10mg per lml solution, according to the law (General 0621), the specific rotation was 84 ° to 90 °.
Last Update:2022-01-01 11:35:30
Okasa-mascul - Introduction
Insoluble in water, soluble in alcohol, ether, pyridine, vegetable oil.
Last Update:2022-10-16 17:26:31
Okasa-mascul - Uses and methods of synthesis
Open Data Unverified Data
pharmacological action
- testosterone propionate is also known as testosterone propionate, testosterone propionate, white crystal or white crystalline powder at room temperature, odorless. Insoluble in water, soluble in ethanol or ether, slightly soluble in vegetable oil, very soluble in chloroform. The pharmacological effect was similar to that of methyltestosterone, but the effect was slightly stronger than that of methyltestosterone. Due to oral easily destroyed by the liver, oral invalid. Often intramuscular injection of its oil solution, absorption is slow, the role of strong and lasting, can be maintained for several days. Testosterone Propionate can promote the development of male organs and secondary sexual characteristics, promote protein synthesis and bone formation, fight against estrogen, inhibit endometrial growth and ovarian, pituitary function. It is used for the treatment of non-testis, cryptorchidism, male hypogonadism, gynecological diseases such as menorrhagia, uterine fibroids, Senile osteoporosis and aplastic anemia.
- This product is first converted into 5α-dihydrotestosterone (5α-dihydrotestosterone) in vivo, and then binds to cell receptors, enters the nucleus, interacts with chromatin, activates RNA polymerase, promotes protein synthesis and cellular metabolism. In addition, testosterone propionate can stimulate the production and differentiation of red blood cells by erythropoietin. Although oral testosterone propionate can be absorbed, but in the liver will be rapidly destroyed and failure, it is generally used intramuscular injection. After intramuscular injection of testosterone propionate, the absorption is slow, and the effect is prolonged for 2 to 4 days. In Blood, 98% of testosterone is bound to the sex hormone globulin and only 2% is free. The half-life was 10~20min. After testosterone was inactivated in the liver, the metabolites were androsterone, isoandrosterone and procyanidone. They are 90% excreted in the urine in combination with glucuronic acid and sulfuric acid. About 6% of the unbound form of the product is excreted by bile, a small fraction of which is still resorbed, forming the enterohepatic circulation.
purpose
for the treatment of breast cancer, ovarian cancer, uterine fibroids, multiple myeloma and kidney cancer.
Last Update:2022-01-01 08:48:26
Okasa-mascul - 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 72).
Last Update:2022-01-01 11:35:30
Okasa-mascul - Safety Information
Open Data Unverified Data
- dangerous goods Mark T
- hazard category code 45-22-63
- safety instructions 53-36/37-45
- dangerous goods transport number 2811
- WGK Germany 3
- RTECS No. XA3115000
Last Update:2022-01-01 08:48:27
Okasa-mascul - Exam
Authoritative Data Verified Data
Related substances
take this product, add methanol to dissolve and dilute to prepare a solution containing about every 1ml, as a test solution, take 1ml for precision measurement, and put it in a 100ml measuring flask, as a control solution, it was diluted to the scale with methanol and shaken. According to the chromatographic conditions under the content determination item, each lol of the test solution and the control solution is accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram is recorded to 2 times of the retention time of the main component chromatographic 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 0.5 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 the main peak area of the control solution (1.0%). 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, in 105C dry to constant weight, weight loss should not exceed 0.5% (General rule 0831).
Last Update:2022-01-01 11:35:31
Okasa-mascul - Usage and dosage
Open Data Unverified Data
- intramuscular injection: usually 25mg once, 2-3 times per week. Androgen Deficiency: intramuscular injection of 1 times 10~50mg, 2~3 times a week. Menorrhagia or uterine fibroids: each intramuscular injection of 25~50mg, 2 times a week. Functional uterine bleeding, with the use of progesterone: each intramuscular injection of 25~50mg, once every other day, a total of 3~4 times. Aplastic anemia: daily or every other day intramuscular injection of 100mg, used for more than 6 months. Senile osteoporosis: each intramuscular injection of 25mg, 2 to 3 times a week, 3 to 6 months.
- female breast cancer and breast cancer bone metastasis: 50~100mg every time, once every other day, 2~3 months. Large doses can cause female virilization, edema, liver damage, jaundice, dizziness and so on. Patients with allergic reactions should be discontinued. Liver, renal insufficiency, prostate cancer patients and pregnant women. Injection such as crystallization, can be heated to dissolve after injection. Pregnant and lactating women, patients with prostate cancer should be disabled; Liver function should be checked regularly during medication, if there is liver damage, drugs should be reduced or discontinued; Children before puberty should be reduced, and every 6 months to measure a bone age. Injection: each 10mg(1ml), 25mg(1ml), 50mg(1ml).
Last Update:2022-01-01 08:48:27
Okasa-mascul - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
using eighteen alkyl silane bonded silica gel as filler I with methanol-water (80:20) as mobile phase, the flow rate was adjusted so that the retention time of testosterone propionate peak was about 12 minutes; the detection wavelength is about 50mg of this product, add an appropriate amount of methanol to dissolve, add 5ml of lmol/L sodium hydroxide solution, shake, place at room temperature for 30 minutes, adjust to Neutral with lmol/L hydrochloric acid solution, transfer to 50ml measuring flask, dilute to the calibration with methanol, shake well, take 10ul injection liquid chromatograph, record chromatogram, testosterone propionate peak and degradation product peak (relative retention time is about 0.4) the degree of separation between should not be less than 20. The number of theoretical plates is not less than 4000 calculated from the testosterone propionate peak.
assay
take about 25mg of this product, precision weighing, put in 25ml measuring flask, add methanol to dissolve and dilute to the scale, shake, take 5ml precision, put in 25ml measuring flask, dilute to scale with methanol, shake, as a test solution, take 10ul injection liquid chromatograph with precision, record chromatogram; Take testosterone propionate reference substance, and calculate the peak area according to external standard method, that's right.
Last Update:2022-01-01 11:35:32
Okasa-mascul - Function
Open Data Unverified Data
- The effect is the same as testosterone and methyltestosterone, but the time of intramuscular injection is more lasting, and it can be injected once every 2 to 3 days. It is clinically applicable to the disease of non-testis, cryptorchidism, male hypogonadism; Gynecological diseases such as menorrhagia, uterine fibroids; Senile osteoporosis and aplastic anemia. By stimulating the kidney to secrete erythropoietin, or has a direct stimulating effect on the bone marrow. Androgen replacement therapy for primary Testicular hypofunction; Hypoplasia of sexual organs.
- Large doses can cause female virilization, edema, liver damage, jaundice, dizziness and so on. Patients with allergic reactions should be discontinued. Liver, renal insufficiency, prostate cancer patients and pregnant women. Injection such as crystallization, can be heated to dissolve after injection. Developmental delay of adolescence and dwarfism; Various chronic wasting diseases, etc.
Last Update:2022-01-01 08:48:28
Okasa-mascul - Category
Authoritative Data Verified Data
Last Update:2022-01-01 11:35:32
Okasa-mascul - Adverse reactions
Open Data Unverified Data
- 17-alpha alkyl substituted testosterone has some toxicity to the liver and can cause jaundice. Long-term use in female patients may cause acne, hirsutism, voice thickening, sexual desire change and other male performance. When hepatic dysfunction and virilizing manifestations of the female are noted, the drug should be discontinued immediately. Large doses can cause female virilization, edema, liver damage, jaundice, dizziness and so on.
- patients with allergic reactions should be discontinued. Liver, renal insufficiency, prostate cancer patients and pregnant women. Injection such as crystallization, can be heated to dissolve after injection. Pregnant and lactating women, patients with prostate cancer should be disabled; Liver function should be checked regularly during medication, if there is liver damage, drugs should be reduced or discontinued; Children before puberty should be reduced, and every 6 months to measure a bone age.
Last Update:2022-01-01 08:48:28
Okasa-mascul - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update:2022-01-01 11:35:32
Okasa-mascul - Testosterone Propionate injection
Authoritative Data Verified Data
This product is a sterile oil solution of testosterone propionate. The content of testosterone propionate should be 90.0% to 110.0% of the labeled amount.
trait
This product is colorless to light yellow clear oily liquid.
identification
- take an appropriate amount of this product (about 10mg equivalent to testosterone propionate), add 10ml of anhydrous ethanol, shake strongly, place it in an ice bath to make it layered, take the upper ethanol solution and centrifuge it in a centrifuge tube, the supernatant was taken as the test solution, and the testosterone propionate control was taken, and anhydrous ethanol was added to prepare a solution containing about 1 mg per 1 ml as the control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions 10u1, respectively, on the same silica gel GF254 thin layer plate, with dichloromethane-methanol (19:0.5) as the developing solvent, open, dry, and set the UV light (254nm) to view. 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.
- (1), (2) and (2) above can be selected as one part.
examination
- for related substances, take the test solution under the content determination item as the test solution; Take 1 ml for precise measurement, put it in a 100ml measuring flask, dilute it to the scale with methanol, and shake it well, as a control solution. The test was performed according to the method under the item testosterone propionate related substances. If there are impurity peaks in the chromatogram of the test solution, the peak of the auxiliary material (benzyl alcohol) before the retention time of the relative main peak is 0.25, the single impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, and 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 0.02 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 50mg equivalent to testosterone propionate) with a volume pipette, put it in a 50m l measuring flask, wash the inner wall of the pipette with ether for several times, wash the liquid and the flask, dilute with diethyl ether to the scale, shake, Take 5ml accurately, place the plug in the centrifuge tube, volatilize the diethyl ether in a warm water bath, and shake 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, take 10 u1 for precision measurement and get it by the method under the item of testosterone propionate content determination.
category
Same as testosterone propionate.
specification
- lml:11mg
- lml:25mg
- lml:50mg
- lml:lOOmg
storage
light shielding, closed storage.
Last Update:2022-01-01 11:35:33
Okasa-mascul - Exam
Open Data Unverified Data
- the relevant substances should be weighed accurately, dissolved in methanol and diluted to prepare a solution containing about 1mg per 1ml, which should be used as a sample solution, set in a 50ml measuring flask, dilute to the scale with methanol, and shake well to serve as a control solution. According to the chromatographic conditions under the content measurement item, 10 μl of the control solution is injected into the liquid chromatograph, and the detection sensitivity is adjusted so that the peak height of the main component reaches 50% of the full scale of the recorder. Then 10 μl of the test solution and the control solution are respectively injected into the liquid chromatograph, and the chromatogram is recorded to 1.5 times of the retention time of the main component peak.
- if there are impurity peaks in the chromatogram of the test solution, it should not be more than 1. The peak area shall not be greater than 3/4 of the main peak area of the control solution. Weight loss on drying take this product, dry to constant weight at 105 ℃, weight loss shall not exceed 0.5%.
Last Update:2022-01-01 08:48:30
Okasa-mascul - Content determination
Open Data Unverified Data
- was measured by high performance liquid chromatography (Appendix V D). Chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica as filler; Methanol-water (65:35) as mobile phase; The detection wavelength was 254nm. The number of theoretical plates should be no less than 1000 according to the calculation of progesterone peak, and the separation degree of progesterone peak and internal standard substance peak should meet the requirements. Preparation of internal standard solution about 25mg of diethylstilbestrol was accurately weighed and placed in a 25ml measuring flask.
- The solution was dissolved in methanol and diluted to the scale. Measure about 25mg of this product, accurately weigh it, put it in a 25ml measuring flask, dissolve it in methanol and dilute it to the scale, shake it well; Take 5ml of the solution and 5ml of the internal standard solution, place in a 25ml measuring flask, dilute to the scale with methanol, shake well, inject 5 μl into the liquid chromatograph, and record the chromatogram.
Last Update:2022-01-01 08:48:30
Okasa-mascul - Precautions
Open Data Unverified Data
The liver function should be checked regularly in the course of medication, and the drug should be stopped in time if any damage is found. Injection such as crystallization, can be dissolved after heating and then use. Should be used for deep intramuscular injection, not for intravenous infusion. For breast cancer treatment, within 3 months should be effective, if the disease is still progressing, should immediately stop. It is generally not changed with other testosterone preparations because of their different duration of action.
Last Update:2022-01-01 08:48:31