56390-09-1
Epirubicin HCl
CAS: 56390-09-1
Molecular Formula: C27H30ClNO11
56390-09-1 - Names and Identifiers
| Name | Epirubicin HCl |
| Synonyms | ELLENCE CS-1396 Epirubicin HCl PHARMORUBICIN Epirubicin Ebewe EPIRUBICIN EBEWE epi-Doxorubicin HCl epirubicin hydrochloride l-erythro-dihydrosphingosine Epirubicin HCl (4'-epidoxorubicin) (1S,3S)-3,5,12-trihydroxy-3-(hydroxyacetyl)-10-methoxy-6,11-dioxo-1,2,3,4,6,11-hexahydrotetracen-1-yl 3-amino-2,3,6-trideoxy-beta-L-arabino-hexopyranoside |
| CAS | 56390-09-1 |
| EINECS | 260-145-2 |
| InChI | InChI=1/C27H29NO11/c1-10-22(31)13(28)6-17(38-10)39-15-8-27(36,16(30)9-29)7-12-19(15)26(35)21-20(24(12)33)23(32)11-4-3-5-14(37-2)18(11)25(21)34/h3-5,10,13,15,17,22,29,31,33,35-36H,6-9,28H2,1-2H3/t10-,13-,15-,17+,22-,27-/m0/s1 |
| InChIKey | MWWSFMDVAYGXBV-UAOJCOQHSA-N |
56390-09-1 - Physico-chemical Properties
| Molecular Formula | C27H30ClNO11 |
| Molar Mass | 579.9802 |
| Density | 1.61g/cm3 |
| Melting Point | 185°C dec. |
| Boling Point | 810.3°C at 760 mmHg |
| Specific Rotation(α) | D20 +274° (c = 0.01 in methanol) |
| Flash Point | 443.8℃ |
| Solubility | Soluble in water (116 mg/mL) at 25 °C, DMSO (116 mg/mL) at 25 °C, ethanol (3 mg/mL) |
| Vapor Presure | 9.64E-28mmHg at 25°C |
| Appearance | powder |
| Color | red to deep red |
| Storage Condition | Inert atmosphere,Store in freezer, under -20°C |
| Stability | Stable for 2 years from date of purchase as supplied. Solutions in DMSO or distilled water may be stored at -20° for up to 3 months. |
| Refractive Index | 1.709 |
| MDL | MFCD00941448 |
| Use | Belongs to antibiotics, mainly used for acute, chronic leukemia, malignant lymphoma and other diseases treatment |
56390-09-1 - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R22 - Harmful if swallowed R63 - Possible risk of harm to the unborn child R62 - Possible risk of impaired fertility R46 - May cause heritable genetic damage R40 - Limited evidence of a carcinogenic effect |
| Safety Description | S36/37/38 - S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S46 - If swallowed, seek medical advice immediately and show this container or label. |
| WGK Germany | 3 |
| RTECS | QI9295750 |
| HS Code | 29419090 |
56390-09-1 - Standard
Authoritative Data Verified Data
This product is (8S,10s)-10-[(3-amino -2,3, 6-trideoxy-a-L-arabinopyranosyl) oxy]-6,8,11-trihydroxy-8-(hydroxyacetyl)-l-methoxy-7, 8,9, 10-tetrahydrotetraphenyl-5, 12-Dione hydrochloride. The epirubicin hydrochloride (C27H29NO11 • HCl) should be between 97.0% and 102.0% calculated as water-free and solvent-free.
Last Update：2024-01-02 23:10:35
56390-09-1 - Trait
Authoritative Data Verified Data
- This product is red or orange-red powder; There is moisture.
- This product is dissolved in water or methanol, slightly soluble in ethanol, insoluble in ether.
specific rotation
take this product, precision weighing, add methanol to dissolve and quantitatively dilute to make a solution containing about 0621 mg per lml, and determine according to law (general rule), calculate according to anhydrous and solvent-free substances, the specific rotation was 310 ° to 340 °.
absorption coefficient
take this product, precision weighing, add methanol to dissolve and quantitatively dilute to make a solution containing about 15ug per lml, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 495nm, and the absorption coefficient was 200 to 230 in terms of anhydrous and solvent-free materials.
Last Update：2022-01-01 15:05:30
56390-09-1 - 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 solution under the term of absorption coefficient was determined by UV-Vis spectrophotometry (General rule 0401), at 234nm, 252nm, 288nm, there is a maximum absorption at the wavelength of 479Nm and 495nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1022).
- Take 10mg of this product, add 0.5ml nitric acid to dissolve, add 0.5ml of water, flame burn for 2 minutes, let it cool, drop silver nitrate test solution to generate white curd-like precipitate.
Last Update：2022-01-01 15:05:30
56390-09-1 - Exam
Authoritative Data Verified Data
acidity
take this product, add water to make a solution containing 5mg per lml, according to the law (General 0631),pH value should be 4.0~5.5.
clarity of the solution
take 5 parts of this product, each 10 mg, respectively, add water 5ml to dissolve, the solution should be clear; If it is turbid, compare with No. 1 turbidity standard solution (General rule 0902 first method), none should be more concentrated.
Related substances
take this product, add the mobile phase to dissolve and dilute to make a solution containing about 0.5mg per lml, as a test solution; Take the appropriate amount of precision, A solution containing about 5ug per 1 ml was prepared as a control solution by quantitative dilution with mobile phase. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution and the control solution are respectively injected into the liquid chromatograph, and the chromatogram is 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, doxorubicin ketone shall not be greater than the main peak area of the control solution (0.7) calculated by the corrected peak area (multiplied by the correction factor of 1.0% ) , the Peak area of doxorubicin shall not be greater than the main peak area of the control solution (1.0% ) , and the peak area of other individual impurities shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, the sum of each impurity peak area (calculated as doxorubicin ketone corrected peak area) shall not be greater than 2 times (2.0%) the area of the main peak of the control solution.
residual solvent
ethanol, acetone and methylene chloride take this product about 0.5g, precision weighing, top empty bottle, precision add water 5ml to dissolve, seal, as a test solution; accurately weigh appropriate amounts of ethanol, acetone and dichloromethane respectively, and quantitatively dilute with water to make a mixed solution containing ethanol 500ug, acetone 500ug and dichloromethane 60ug per 1 ml, and accurately measure 5ml, top empty bottle, sealed, as a control solution. According to the determination method of residual solvent (General Principle 0861 first method), the capillary column with 5% phenyl-95% dimethyl polysiloxane (or similar polarity) as the stationary liquid is the column, and the column temperature is 50°C; the inlet temperature was 200°C; The detector temperature was 250°C. The Headspace bottle equilibration temperature was 80°C and the equilibration time was 30 minutes. Take the reference solution into the headspace, ethanol, acetone and dichloromethane peaks sequentially, the separation degree between the main peaks should meet the requirements. Take the sample solution and the reference solution into the headspace respectively, record the chromatogram, calculate the peak area according to the external standard method, the residual amount of ethanol shall not exceed 1.0%, the residual amount of acetone shall not exceed 1.5%, the residual amount of methylene chloride should be in accordance with the regulations.
dioxane and pyridine
take an appropriate amount of this product, accurately weigh it, add water to dissolve and quantitatively dilute it to make a solution containing about 50mg per lml as a test solution; Take an appropriate amount of dioxane and pyridine by precision weighing, A mixed solution containing about 38ug of dioxane and 20ug of pyridine per 1 ml was prepared by quantitative dilution with water as a reference solution. According to the determination method of residual solvent (General Principle 0861 third method), the capillary column with 5% phenyl-95% dimethyl polysiloxane (or polar similar) as the stationary liquid was used as the column; The column temperature was 100°C. The reference solution lul is injected into the gas chromatograph, and the chromatogram is recorded. The resolution between the dioxane peak and the pyridine peak shall meet the requirements. The sample solution and the reference solution were injected into the gas chromatograph respectively, and the chromatogram was recorded. According to the external standard method to calculate the peak area, dioxane and pyridine residues should be in accordance with the provisions.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 3.0%.
antihypertensive substances
take this product, check according to law (General rule 1145), the dose of the cat weight per lkg injection of lmg, should meet the requirements. (For injection)
bacterial endotoxin
take this product, check according to law (General 1143), each 1 mg epirubicin hydrochloride containing endotoxin should be less than 1.1EU. (For injection)
Last Update：2022-01-01 15:05:31
56390-09-1 - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
The mixture of acetonitrile-water-methanol-85% Phosphoric acid solution (290:540:170:1) and 0.2% sodium dodecyl sulfate was used as mobile phase, the flow rate was 2.0ml per minute; The detection wavelength was 254nm; And the column temperature was 35°C. Take appropriate amount of doxorubicin ketone, doxorubicin hydrochloride and epirubicin hydrochloride respectively, add mobile phase to dissolve and dilute to prepare about 30ug doxorubicin ketone per lml, take 20ul of the mixed solution of doxorubicin hydrochloride 30ug and epirubicin hydrochloride 100ug and inject it into human liquid chromatograph. Record the chromatogram, the degree of separation between epirubicin peak and doxorubicin peak should be greater than 2.0, and the tailing factor of epirubicin peak should be 0.8-1.4.
assay
take the appropriate amount of this product, precision weighing, plus mobile phase dissolution and quantitative dilution made from each lml containing about O.lmg solution was used as the test solution, and 20u1 was injected into the liquid chromatograph for precise measurement, and the chromatogram was recorded. The reference substance of epirubicin hydrochloride was taken and determined by the same method. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 15:05:32
56390-09-1 - Category
Authoritative Data Verified Data
Anti-tumor antibiotics.
Last Update：2022-01-01 15:05:32
56390-09-1 - Storage
Authoritative Data Verified Data
shade, seal, and store in a cool and dry place.
Last Update：2022-01-01 15:05:32
56390-09-1 - Epirulbicin Hydrochloride for Injection
Authoritative Data Verified Data
This product is epirubicin hydrochloride plus suitable excipients or (and) bacteriostatic agent made of sterile lyophilized product, calculated by the average content or average loading, epirubicin hydrochloride (C27H29NO11 • HCl) shall be 90.0% to 110.0% of the labeled amount.
trait
This product is red or orange-red loose lumps or powder; There is hygroscopicity.
identification
take an appropriate amount of this product, and show the same results according to the tests (1) and (4) under the item of epirubicin hydrochloride.
examination
- acidity: Take appropriate amount of this product and add water to make a solution containing 2mg epirubicin hydrochloride per lml, and measure it according to law (General rule 0631). The pH value should be 4.5~6.0.
- the clarity of the solution 5 bottles of this product, according to the label amount of water were made containing 2mg per 1 ml of solution, the solution should be clear; If it is turbid, compared with No. 1 turbidity standard solution (General Principles 0902 first method), shall not be more concentrated.
- Related substances take this product, add mobile phase to dissolve and dilute to prepare a solution containing about 0.5mg epirubicin hydrochloride per 1 ml as a test solution, determination according to the method under epirubicin hydrochloride. If there are impurity peaks in the chromatogram of the test solution (except for methyl hydroxybenzoate), doxorubicin ketone shall be calculated according to the corrected peak area (multiplied by the correction factor of 0.7). Shall not be greater than the main peak area of the control solution (1.0% ) , the peak area of doxorubicin shall not be greater than the main peak area of the control solution (1.0% ) , and the peak area of other individual impurities shall not be greater than 0.8 times (0.8%) of the main peak area of the control solution, the sum of each impurity peak area (calculated as doxorubicin ketone corrected peak area) shall not be greater than 2.5 times (2.5%) of the main peak area of the control solution.
- The test solution under the content determination item of hydroxybenzene is used as the test solution; The appropriate amount of reference substance of methyl hydroxybenzoate is taken, and the precision is weighed, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 20ug per 1 ml as a control solution. According to the method under the content determination item, the peak area shall be calculated according to the external standard method. If the content of methyl hydroxybenzoate is 80.0% ~ 120.0% of the label amount (10 mg specification, each bottle contains 2mg of methyl hydroxybenzoate; 50mg specification, each bottle contains 10 mg of methyl hydroxybenzoate).
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 4.0%, first method 1).
- Content uniformity (10 mg specification) shall be calculated from the content of each bottle measured under the content determination item, and shall comply with the regulations (General 0941).
- sterile take this product, dissolve and dilute with appropriate solvent, after the membrane filtration method, inspection according to law (General rule 1101), should comply with the provisions.
- The antihypertensive substance and bacterial endotoxin shall be checked according to the method under epirubicin hydrochloride, and shall comply with the regulations.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
Take 10 bottles of this product (10 mg specification), add mobile phase to dissolve and quantitatively dilute according to the indicated amount, and make it into about 0 ml per lml. lmg solution, or take the content of the product under the difference in the amount of the product (50mg specification), Precision weighing to take the right amount, add mobile phase dissolution and quantitative dilution to prepare epirubicin hydrochloride in each 1 ml 0.lmg solution, as a test solution, according to the method under epirubicin hydrochloride, according to the external standard method to calculate the content of each bottle by Peak area, the average content of 10 vials (10 mg specification) was determined or the content of epirubicin hydrochloride per 1 mg (50mg specification) was calculated.
category
Same as epirubicin hydrochloride.
specification
(1) 10mg (2)50mg.
storage
shade, seal, and store in a cool place.
Last Update：2022-01-01 15:05:33
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Spot supply
Product Name: Epirubicin hydrochloride Visit Supplier Webpage Request for quotationCAS: 56390-09-1
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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