17alpha-Hydroxyprogesterone caproate - Names and Identifiers
Name | 17A-hydroxyprogesterone hexanoate
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Synonyms | Hydroxyprogesterone Caproate Hydroxy progesterone caproate HYDROXYPROGESTERONECAPROATE,USP 17A-Hydroxyprogesterone Caproate PREGN-4-ENE-3,20-DIONE HEXANOATE 17α-Hydroxyprogesterone hexanoate 17A-hydroxyprogesterone hexanoate 17α-Hydroxyprogesterone n-caproate 17α-Caproyloxypregn-4-ene-3,20-dione 3,20-dioxopregn-4-en-17-yl hexanoate 3,20-Dioxopregn-4-en-17α-yl caproate 17alpha-Hydroxyprogesterone caproate 3,20-dioxopregn-4-en-17-alpha-yl hexanoate (8xi,9xi,14xi)-3,20-dioxopregn-4-en-17-yl hexanoate (8xi,10xi,13xi)-3,20-dioxopregn-4-en-17-yl hexanoate Pregn-4-ene-3,20-dione, 17-hydroxy-, hexanoate (7CI, 8CI) Hexanoic acid, ester with 17-hydroxypregn-4-ene-3,20-dione (8CI)
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CAS | 630-56-8
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EINECS | 211-138-8 |
InChI | InChI=1/C27H40O4/c1-5-6-7-8-24(30)31-27(18(2)28)16-13-23-21-10-9-19-17-20(29)11-14-25(19,3)22(21)12-15-26(23,27)4/h17,21-23H,5-16H2,1-4H3/t21?,22?,23?,25-,26-,27-/m0/s1 |
InChIKey | DOMWKUIIPQCAJU-LJHIYBGHSA-N |
17alpha-Hydroxyprogesterone caproate - Physico-chemical Properties
Molecular Formula | C27H40O4
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Molar Mass | 428.6 |
Density | 1.0148 (rough estimate) |
Melting Point | 119°C |
Boling Point | 463.43°C (rough estimate) |
Specific Rotation(α) | +44~+50°(D/20℃)(c=1,CH3OH) |
Flash Point | 227.6°C |
Solubility | Chloroform (Slightly), Methanol (Slightly) |
Vapor Presure | 1.4E-11mmHg at 25°C |
Appearance | Solid |
Color | Off-White |
Merck | 4839 |
Storage Condition | Sealed in dry,Room Temperature |
Refractive Index | 1.4840 (estimate) |
MDL | MFCD00072134 |
Use | Used as progestogen |
In vivo study | Pregnant rats were treated with hydroxyprogestone caproate to test the effect of intraperitoneal injection of supernormal levels on the reproductive potential of first-generation males. The number of caudal epididymal sperm and their motility were significantly reduced in rats treated with Hydroxyprogesterone caproate during embryonic development. After treatment in the embryonic period, adult rats will show a decrease in serum testosterone levels and an increase in follicle-stimulating hormone and luteinizing hormone. |
17alpha-Hydroxyprogesterone caproate - Risk and Safety
Hazard Symbols | T - Toxic
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Risk Codes | 61 - May cause harm to the unborn child
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Safety Description | S53 - Avoid exposure - obtain special instructions before use.
S22 - Do not breathe dust.
S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection.
S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.)
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WGK Germany | 3 |
RTECS | TU5085000 |
HS Code | 2937230000 |
17alpha-Hydroxyprogesterone caproate - Standard
Authoritative Data Verified Data
This product is (17a)-17-hydroxyprogestin -4-ene -3,20-diketocaproate. The content of C27H40O4 shall be 97.0% ~ 103.0% calculated as dry product.
Last Update:2024-01-02 23:10:35
17alpha-Hydroxyprogesterone caproate - Trait
Authoritative Data Verified Data
- This product is white or white crystalline powder; Odorless.
- This product is soluble in ethanol, acetone or ether, slightly soluble in tea oil or castor oil, insoluble in water.
melting point
The melting point of this product (General 0612) is 120~124°C.
specific rotation
take this product, precision weighing, plus chloroform dissolved and quantitatively diluted to make about 10mg per lml solution, according to the law (General 0621), the specific rotation was 58 ° to 64 °.
Last Update:2022-01-01 11:31:22
17alpha-Hydroxyprogesterone caproate - Differential diagnosis
Authoritative Data Verified Data
- take about 1 mg of this product, add 1ml of sulfuric acid, place it for 2 minutes, gradually yellow; Add 0.5ml of water, and the solution changes from green to red to red-purple with blue 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 28).
Last Update:2022-01-01 11:31:22
17alpha-Hydroxyprogesterone caproate - Exam
Authoritative Data Verified Data
acidity
take 0.20g of this product, add 25ml of neutral anhydrous ethanol (neutral to the indicator solution of bromothymol blue) to dissolve, immediately add several drops of the indicator solution of bromothymol blue and use sodium hydroxide titration solution (0.02mol/L) titrate to a microscopic blue color and consume no more than 0.02 of sodium hydroxide titrant (0.50 mol/L).
Related substances
take an appropriate amount of this product, add methanol to dissolve and dilute to prepare a solution containing about 1 mg per 1 ml as a test solution; Take an appropriate amount for precision measurement, A solution containing about 16ug per 1 ml was prepared as a control solution by quantitative dilution with methanol. According to the chromatographic conditions under the content determination item, 5 u1 of the test solution and the control solution are accurately taken, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded to 2 times of the retention time of the main component peak. If there are no more than 4 impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be more than 0.5 times (0.8%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 0.75 times (1.2%) of the main peak area of the control solution.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).
Last Update:2022-01-01 11:31:23
17alpha-Hydroxyprogesterone caproate - 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; Methanol-water (85:15) was used as a mobile phase; The detection wavelength was 254mn. The number of theoretical plates shall not be less than 2000 calculated by the peak of hydroxyprogesterone caproate, and the separation degree between the peak of hydroxyprogesterone caproate and the peak of internal standard substance shall meet the requirements. Preparation of internal standard solution norethisterone was dissolved in methanol and diluted to prepare a solution containing about 1 mg per 1 ml.
assay
take an appropriate amount of this product, accurately weigh it, add methanol to dissolve and quantitatively dilute it to make a solution containing about 1 mg per 1 ml. Take 2ml of the solution and 2ml of the internal standard solution for precision measurement, in a 10ml measuring flask, dilute to the scale with methanol, shake well, as a test solution, take 5M1 injection liquid chromatograph, record the chromatogram; Take the two reference substances of hexanoic acid hydroxypregnancy, and determine with the same method. According to the internal standard method to calculate the peak area, that is.
Last Update:2022-01-01 11:31:23
17alpha-Hydroxyprogesterone caproate - Category
Authoritative Data Verified Data
Last Update:2022-01-01 11:31:24
17alpha-Hydroxyprogesterone caproate - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update:2022-01-01 11:31:24
17alpha-Hydroxyprogesterone caproate - Hydroxyprogesterone caproate injection
Authoritative Data Verified Data
This product is a sterile oil solution of hydroxyprogesterone caproate. Containing hydroxyprogesterone caproate (C27H4004) shall be between 90.0% and 110.0% of the labeled amount.
trait
This product is a light yellow to yellow clear oily liquid.
identification
- take an appropriate amount of this product, diluted with chloroform made per lml containing hydroxyprogesterone caproate l. Solution of Om g, as a test solution: another hydroxyprogesterone caproate control was taken, dissolved and diluted with chloroform to make 1 per 1 ml. 0 mg solution, as a control solution. According to the thin layer chromatography (General 0502) test, take 10 ml of each of the above two solutions, respectively point on the same silica gel HF254 thin layer plate, with cyclohexane-ethyl acetate (1:1) as the developing solvent, expand, dry, and put under UV light (254mn). 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.
- two items (1) and (2) above can be selected as one item.
examination
should comply with the relevant provisions under the injection (General Principle 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-water (85:15) as mobile phase; The detection wavelength was 254mn. Take appropriate amount of hydroxyprogesterone caproate reference substance and estradiol valerate reference substance, dissolve them with methanol and make a mixed solution containing about 20ug in each lml, take 10u1 injection human liquid chromatograph, record chromatogram, the resolution of the hydroxyprogesterone caproate peak and the estradiol valerate peak should meet the requirements.
- The determination method uses a volume pipette to precisely measure an appropriate amount of this product, and quantitatively dilute it with methanol to prepare a solution containing about 20ug per lml, which is used as a test solution, note human liquid chromatograph, record chromatogram; Take the reference substance of hydroxyprogesterone caproate, precisely weigh, add methanol to dissolve and quantitatively dilute to make a solution containing about 20ug per lml, and determine with the same method, according to the external standard method to calculate the peak area, that is.
category
hydroxyprogesterone hexanoate
specification
- lml:0.125g
- 2ml:0.25g
- lml:0.25g
storage
light shielding, closed storage.
Last Update:2022-01-01 11:31:25
17alpha-Hydroxyprogesterone caproate - Compound hydroxyprogesterone caproate injection
Authoritative Data Verified Data
This product is a sterile oil solution of hydroxyprogesterone caproate and estradiol valerate. Containing hydroxyprogesterone caproate (C27H40O4) and estradiol valerate (C23H32O3) should be 90.0% to 110.0% of the label amount.
trait
This product is a light yellow to yellow clear oily liquid.
identification
- take this product and dilute it with absolute ethanol to make a solution containing 1 mg of estradiol valerate and 5mg of hydroxyprogesterone caproate per 1 ml as the test solution; Take estradiol valerate and hydroxyprogesterone caproate as the control, dissolve and dilute with absolute ethanol to make estradiol valerate 0. A solution of 1 mg and 5mg of hydroxyprogesterone caproate was used as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions of 20 u1, respectively, on the same silica gel G thin layer plate, with cyclohexane-ethyl acetate-triethanolamine (50:50:50:0.5) for the development of the agent, expand, dry, spray with sulfuric acid-ethanol (1:1), heated at 110°C for 5~10 minutes to color, the position and color of the two main spots displayed by the test solution should be the same as the main spots corresponding to 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 corresponding 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 injection (General Principle 0102).
Content determination
- determined by HPLC (General 0512) ^
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-water (85:15) as mobile phase, the flow rate was 0.7 per minute; The detection wavelength was 225nm. The resolution of the hydroxyprogesterone caproate peak and the estradiol valerate peak should meet the requirements.
- with the internal volume pipette, take 1ml of this product accurately, put it in a 25ml measuring flask, dilute it to the scale with methanol, shake well, take 1ml accurately and put it in a 10ml measuring flask, dilute with methanol to the scale, shake well, as estradiol valerate test solution; Take this solution 1ml, put in 50ml measuring flask, dilute with methanol to the scale, shake well, as the test solution of hydroxyprogesterone caproate; Take 10ul of each of the above two test solutions, respectively inject human liquid chromatography, record the chromatogram; Take estradiol valerate and hydroxyprogesterone caproate reference, precision weighing, dissolving and quantitatively diluting with methanol to make a solution containing about 20ug of estradiol valerate and 20ug of hydroxyprogesterone caproate in each lml, which is used as a reference solution and determined by the same method, and calculated by peak area according to external standard method.
category
progesterone drugs.
specification
lml: hydroxyprogesterone caproate 250mg vs estradiol valerate 5Mg
storage
sealed and protected from light.
Last Update:2022-01-01 13:43:09