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125-04-2

Hydrocortisone Sodium Succinate

CAS: 125-04-2

Molecular Formula: C25H33O8.Na

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125-04-2 - Names and Identifiers

Name Hydrocortisone Sodium Succinate
Synonyms Hydorcortisone Sodium Succinate
Hydrocortisone Sodium Succinate
HYDROCORTISONE SODIUM SUCCINATE
Hydrocortisone-21-sodium Succinate
HYDROCORTISONE 21-HEMISUCCINATE SODIUM
HYDROCORTISONE HEMISUCCINATE SODIUM SALT
HYDROCORTISONE 21-HEMISUCCINATE SODIUM SALT
HYDROCORTISONE-HYDROGEN SUCCINATE SODIUM SALT
11b,17a,21-trihydroxy-4-pregnene-3,20-dione 21-hemisuccinate sodium salt
sodium 4-[(11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl)oxy]-4-oxobutanoate
11BETA,17ALPHA,21-TRIHYDROXY-4-PREGNENE-3,20-DIONE 21-HEMISUCCINATE SODIUM SALT
sodium 4-{[(11beta)-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl]oxy}-4-oxobutanoate
11BETA,17ALPHA,21-TRIHYDROXY-4-PREGNENE-3,20-DIONE 21-HEMISUCCINATE SODIUM-POTASSIUM SALT
CAS 125-04-2
EINECS 204-725-5
InChI InChI=1/C25H34O8.Na/c1-23-9-7-15(26)11-14(23)3-4-16-17-8-10-25(32,24(17,2)12-18(27)22(16)23)19(28)13-33-21(31)6-5-20(29)30;/h11,16-18,22,27,32H,3-10,12-13H2,1-2H3,(H,29,30);/q;+1/p-1/t16-,17-,18-,22+,23-,24-,25-;/m0./s1
InChIKey HHZQLQREDATOBM-CODXZCKSSA-M

125-04-2 - Physico-chemical Properties

Molecular FormulaC25H33O8.Na
Molar Mass484.52
Melting Point169.0-171.2°
Boling Point685.5°C at 760 mmHg
Flash Point231.1°C
Solubility H2O: 50mg/mL
Vapor Presure9.36E-22mmHg at 25°C
Appearancepowder
ColorWhite to Off-White
Storage Condition−20°C
UseUsed as a pharmaceutical Intermediate

125-04-2 - Risk and Safety

WGK Germany3
RTECSGM9015000

125-04-2 - Standard

Authoritative Data Verified Data

This product is 11B, 17a-dihydroxy-21-(3-alkyl -1-hydroxypropoxy) pregnane-4-en-3, 20-dione monosodium salt. Based on the dry product, the content of C25H33Na08 should be 97.0%- 102.0%.

Last Update：2024-01-02 23:10:35

125-04-2 - Trait

Authoritative Data Verified Data
  • This product is white or off-white powder; Odorless; With hygroscopicity.
  • This product is soluble in water, slightly soluble in ethanol, insoluble in chloroform.

specific rotation

take this product, precision weighing, plus ethanol dissolution and quantitative dilution of the solution containing about 10 mg per 1 ml, according to the law (General 0621), the specific rotation was 135 ° to 145 °.

Last Update：2022-01-01 13:41:26

125-04-2 - Differential diagnosis

Authoritative Data Verified Data
  1. take 1% aqueous solution of this product, add equal volume of Alkaline copper tartrate test solution, and generate red precipitate after heating.
  2. The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 994).
  3. This product shows the reaction of sodium salt identification (1) (General rule 0301).
Last Update：2022-01-01 13:41:26

125-04-2 - Exam

Authoritative Data Verified Data

clarity and color of solution

take 0.5g of this product, Add 10ml of water to dissolve, the solution should be clear and colorless.

Related substances

take this product, precision weighing, and mobile phase dissolution and quantitative dilution to make a solution containing about 0.2mg per lml, as a test solution (ready to use new system); take 1ml of precision measurement, put it in a 100ml measuring flask, dilute it to scale with mobile phase, shake well, and use it as control solution, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 6ug per 1ml as a control solution. According to the chromatographic conditions under the content determination item, 20ul of the test solution, the control solution and the reference solution are respectively injected into the liquid chromatograph, the chromatogram was recorded to 2 times of the retention time of the main component peak of the test solution. If there is a peak in the chromatogram of the test solution that is consistent with the retention time of the hydrocortisone peak in the chromatogram of the reference solution, the peak area shall be calculated according to the external standard method, and shall not exceed 3.0%; the Peak area of other single impurities shall not be greater than the main peak area of the control solution (1.0%), and the total amount of hydrocortisone and other impurities shall not exceed 3.0%.

loss on drying

take this product, dry at 105°C for 3 hours, loss of weight shall not exceed 2.0% (General rule 0831).

sodium content

take 1.0g of this product, precision weighing, add 75ml of glacial acetic acid, slowly heat to dissolve, let cool, add 20ml of dioxane, add 1 drop of crystal violet indicator solution, with high gas acid titration solution (0.1 mol/L) titration to the solution showed blue purple, and the results of the titration were corrected with a blank test. Per 1 ml of perchloric acid titration solution (0.1 mol/L) is equivalent to 2.299mg of sodium, according to the dry product calculation, sodium content should be 4.60% ~ 4.84%.

Last Update：2022-01-01 13:41:27

125-04-2 - Content determination

Authoritative Data Verified Data

measured by high performance liquid chromatography (General 0512).

chromatographic conditions and system suitability test

with eighteen alkyl silane bonded silica gel as filler; Phosphate buffer solution (8mmol/L potassium dihydrogen phosphate solution, with 8mmol/L dipotassium hydrogen phosphate solution to adjust the pH value to 5.0±0.1, ready to use new system)-Methanol (57:43) as mobile phase; Column temperature 40°C; Detection wavelength of 242mn. Take hydrocortisone sodium succinate and hydrocortisone, add the mobile phase to dissolve and dilute to make a crude solution containing about 0.2mg hydrocortisone sodium succinate and 6ug hydrocortisone per 1 ml, and inject 20ul into human liquid chromatograph, the flow rate was adjusted so that the retention time of the hydrocortisone sodium succinate peak was about 16 minutes, the relative retention time of the hydrocortisone peak relative to the hydrocortisone sodium succinate peak was about 1.2, and the number of theoretical plates was not less than 3000 based on the hydrocortisone sodium succinate peak, the resolution of the hydrocortisone sodium succinate peak from the hydrocortisone peak should be greater than 4.0.

assay

take this product, precision weighing, adding mobile phase to dissolve and quantitatively dilute to make a solution containing about 40ug per lml, and inject 20ul into the liquid chromatograph to record the chromatogram, the same method of determination, according to the external standard method to calculate the peak area, that is.

Last Update：2022-01-01 13:41:28

125-04-2 - Category

Authoritative Data Verified Data

adrenocortical hormone drugs.

Last Update：2022-01-01 13:41:28

125-04-2 - Storage

Authoritative Data Verified Data

light shielding, sealed storage.

Last Update：2022-01-01 13:41:29

125-04-2 - Hydrocortisone Sodium Succinate for Injection

Authoritative Data Verified Data

This product is a sterile lyophilized product made of hydrocortisone sodium succinate and phosphate buffer. Hydrocortisone-containing sodium succinate, calculated as hydrocortisone (C21H3005), shall be between 90.0% and 110.0% of the labeled amount.

trait

This product is white or white loose lumps.

identification

  1. take 1% aqueous solution of this product, add equal volume of Alkaline copper tartrate solution, and generate red precipitate after heating.
  2. 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.
  3. take an appropriate amount of this product (about equivalent to hydrocortisone sodium succinate lOOmg), add 4ml of anhydrous ethanol, fully stir, filter (filter pore size 0.45um or less), take the filtrate, water bath evaporation dry, the residue after evaporation was measured according to the law. The infrared absorption spectrum of this product should be consistent with the spectrum of the control (Spectrum set 994 figure).
  4. This product shows the reaction of sodium salt identification (1) (General rule 0301).

examination

  • alkalinity: take this product, add water to make a solution containing 50mg per lml, and determine it according to law (General rule 0631). The pH value should be 7.0~8.0.
  • the color of the solution is 0.50g, and the solution should be colorless after being dissolved by adding 0901 of water. If the color is colored, it should not be deeper compared with the yellow No. 4 standard colorimetric solution (General rule first method).
  • new system of related substances in clinical use. Take this product, precision weigh, add mobile phase dissolution and quantitative dilution to make a solution containing about 0.2mg of hydrocortisone sodium succinate (based on hydrocortisone) per 1 ml, as the test solution; Take 3ml of precision, in a 100ml measuring flask, dilute to the scale with mobile phase, shake well, and use as a control solution, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 6ug per 1 ml as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution, the control solution and the reference solution are respectively injected into the liquid chromatograph, the chromatogram was recorded to 2 times of the retention time of the main component peak of the test solution. If there is a peak in the chromatogram of the test solution that is consistent with the retention time of the hydrocortisone peak in the chromatogram of the reference solution, the peak area shall be calculated according to the external standard method, and 3.0% of the labeled amount of hydrocortisone shall not be exceeded; the sum of the peak areas of other impurities shall not be greater than the main peak area of the control solution (3.0%).
  • weight loss on drying this product shall be dried at 105°C for 3 hours, and the weight loss shall not exceed 2.0% (General rule 0831).
  • bacterial endotoxin this product, according to the law to check (General 1143), each 1 mg (based on hydrocortisone) in the amount of endotoxin should be less than 0.30EU.
  • abnormal toxicity take this product, add Sterile Water for Injection to make a solution containing 10 mg per 1 mL (based on hydrocortisone), check according to law (General rule 1141), and give it intravenously, the requirements shall be met.
  • others should comply with the relevant provisions under injection (General 0102).

Content determination

  • measured by high performance liquid chromatography (General 0512).
  • chromatographic conditions and system suitability test with eighteen alkyl silane bonded silica gel as filler; Phosphate buffer solution (8mmol/ L potassium dihydrogen phosphate solution, the pH value was adjusted to 5.0±0.1 with 8mmol/ L dipotassium hydrogen phosphate solution, and the mobile phase was freshly prepared)-methanol (57:43); The column temperature was 40°C; The detection wavelength was 242nm. Take hydrocortisone sodium succinate and hydrocortisone, add mobile phase to dissolve and dilute to make a solution containing 0.2mg hydrocortisone sodium succinate and 6ug hydrocortisone per 1 ml, and inject 20u1 into the liquid chromatograph, the flow rate was adjusted so that the peak retention time of hydrocortisone sodium succinate was about 16 minutes, the relative retention time of 17-hydrocortisone sodium succinate peak relative to hydrocortisone sodium succinate peak was about 0.7, and the relative retention time of hydrocortisone peak relative to hydrocortisone sodium succinate peak was about 1.2, the number of theoretical plates is not less than 3000 calculated by the peak of hydrocortisone sodium succinate, and the separation degree between the peak of hydrocortisone sodium succinate and the peak of Hydrocortisone should be greater than 4.0.
  • The content mixed uniformly under the item of difference in loading amount is measured, accurately weighed, dissolved and quantitatively diluted with mobile phase to prepare a solution containing about 40ug of hydrocortisone sodium succinate per 1 ml, as the sample solution, 20 u1 was accurately measured, injected into the liquid chromatograph, and the chromatogram was recorded. The peak order was 17-hydrocortisone sodium succinate, 21-hydrocortisone sodium succinate and hydrocortisone; separately take hydrocortisone sodium succinate and hydrocortisone control, precision weighing, respectively, plus mobile phase dissolution and quantitative dilution made per 1 ml containing about 0.4mg and 0.1 mg solution, 5ml of each of the above two solutions is accurately measured, and the solution is placed in the same 50ml measuring flask, diluted to the scale with mobile phase, shaken, and determined by the same method. Calculated as peak area by external standard method, calculated as the sum of the peak areas of 17-hydrocortisone sodium succinate and 21-hydrocortisone sodium succinate as the peak area of hydrocortisone sodium succinate, and multiplied by 0.748, converted as the amount of hydrocortisone combined with the amount of hydrocortisone, that's right.

category

sodium hydrocortisone succinate.

specification

Based on C21H3005 (1)0.05g (2)0.lg

storage

protected from light and sealed.

Last Update：2022-01-01 13:41:30
125-04-2
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Hubei YoungXin Pharmaceutical Tech Co.,Ltd.
Product Name: Hydrocortisone Hemisuccinate Sodium Salt Request for quotation
CAS: 125-04-2
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Hefei TNJ Chemical Industry Co.,Ltd.
Product Name: Hydrocortisone Sodium Succinate Request for quotation
CAS: 125-04-2
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Hubei YoungXin Pharmaceutical Tech Co.,Ltd.
Product Name: Hydrocortisone Hemisuccinate Sodium Salt Request for quotation
CAS: 125-04-2
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052 Click to send a QQ message
Wechat: 15671228036
Hefei TNJ Chemical Industry Co.,Ltd.
Product Name: Hydrocortisone Sodium Succinate Request for quotation
CAS: 125-04-2
Tel: 0086-551-65418684
Email: sales@tnjchem.com
　　　　 info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840 Click to send a QQ message
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
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125-04-2
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