Mitoxantrone hydrochloride
Mitoxantrone hydrochloride
CAS: 70476-82-3
Molecular Formula: C22H30Cl2N4O6
Mitoxantrone hydrochloride - Names and Identifiers
| Name | Mitoxantrone hydrochloride |
| Synonyms | 70476-82-3 Mitoxantrone hcl Mitoxantrone hydrochloride 1,4-dihydroxy-5,8-bis({2-[(2-hydroxyethyl)amino]ethyl}amino)anthracene-9,10-dione dihydrochloride |
| CAS | 70476-82-3 |
| EINECS | 274-619-1 |
| InChI | InChI=1/C22H28N4O6.3ClH/c27-11-9-23-5-7-25-13-1-2-14(26-8-6-24-10-12-28)18-17(13)21(31)19-15(29)3-4-16(30)20(19)22(18)32;;;/h1-4,23-30H,5-12H2;3*1H |
Mitoxantrone hydrochloride - Physico-chemical Properties
| Molecular Formula | C22H30Cl2N4O6 |
| Melting Point | 203-205 °C |
| Boling Point | 805.7 °C at 760 mmHg |
| Solubility | Soluble in water (89 mg/ml at 25 °C), 100% ethanol (slightly), methanol (slightly), and |
| Appearance | Blue-black solid |
| Storage Condition | 2-8℃ |
| Sensitive | Sensitive to heat |
| MDL | MFCD00242943 |
| Use | Used as an antineoplastic agent |
Mitoxantrone hydrochloride - Risk and Safety
| Hazard Symbols | T - Toxic |
| Risk Codes | R46 - May cause heritable genetic damage R61 - May cause harm to the unborn child |
| Safety Description | S53 - Avoid exposure - obtain special instructions before use. 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.) |
Mitoxantrone hydrochloride - Standard
Authoritative Data Verified Data
This product is 1, 4-dihydroxy-5, 8-bis [[2-[(2-hydroxyethyl) amino] ethyl] amino]-9,10-anthraquinone dihydrochloride. The content of C22H28N406. 2HC1 should be between 97.0% and 102.0%, calculated as anhydrous.
Last Update：2024-01-02 23:10:35
Mitoxantrone hydrochloride - Trait
Authoritative Data Verified Data
- This product is a blue-black crystalline powder; Odorless; With hygroscopicity.
- This product is dissolved in water, slightly soluble in ethanol, insoluble in chloroform.
Last Update：2022-01-01 15:04:05
Mitoxantrone hydrochloride - Differential diagnosis
Authoritative Data Verified Data
- take about 5mg of this product, add 1 ml of water to dissolve, add 1 ml of concentrated sulfuric acid, and change the solution from dark blue to deep purple red.
- 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 824).
- This product is chloride identification reaction (General 0301).
Last Update：2022-01-01 15:04:05
Mitoxantrone hydrochloride - Exam
Authoritative Data Verified Data
acidity
take 0.10g of this product, Add 10ml of water to dissolve it, and then measure it according to law (General rule 0631). The pH value should be 3.0-5.5.
Related substances
take this product, add mobile phase to dissolve and dilute to make a solution containing about 1 mg per 1ml as a test solution; Take 1ml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. 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 2 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 the area of the main peak of the control solution (1.0% ) , and the sum of each impurity peak area shall not be greater than 2 times the area of the main peak of the control solution (2.0%).
moisture
take this product, according to the determination of moisture (General 0832 first method 1), the water content shall not exceed 5.0%.
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.2%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 15:04:06
Mitoxantrone hydrochloride - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with octanoalkyl silane as filler; Sodium heptanesulfonate solution (sodium heptanesulfonate 4.4g, add appropriate amount of water to dissolve, add 6.4ml of glacial acetic acid, dilute to 730ml with water)-acetonitrile (70:30) as mobile phase; The detection wavelength was 244mn. The theoretical plate number is not less than 2000 calculated as the mitoxantrone peak. Take about 2.5mg of mitoxantrone hydrochloride, add 5ml of mobile phase to dissolve, add l precisely. 0 mol/L sodium hydroxide solution 1ml, immediately put 90°C water bath accurately heated for 4 minutes, take out the rapid cooling, Precision Plus l.Omol/L hydrochloric acid solution 1ml, mixing, 20u1 injection liquid chromatography, mitoxantrone main peak and the maximum degradation peak after the separation should be greater than 5.0.
assay
take an appropriate amount of this product, weigh it accurately, add water to dissolve and quantitatively dilute it to make it contain about 0 in each lml. 1 mg of the solution was used as the test solution, and 20u1 was injected into the liquid chromatograph in a precise amount, and the chromatogram was recorded. Another reference substance of mitoxantrone 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 15:04:07
Mitoxantrone hydrochloride - Category
Authoritative Data Verified Data
antineoplastic agents.
Last Update：2022-01-01 15:04:07
Mitoxantrone hydrochloride - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:04:07
Mitoxantrone hydrochloride - Mitoxantrone hydrochloride and sodium chloride injection
Authoritative Data Verified Data
This product is mitoxantrone hydrochloride and appropriate amount of sodium chloride and appropriate stabilizer made of isotonic sterile aqueous solution. Mitoxantrone hydrochloride, calculated as mitoxantrone (C22N28N406), shall be between 90.0% and 110.0% of the labeled amount.
trait
This product is a clear liquid of dark blue.
identification
- take about 5ml of this product and add 5ml of trinitrophenol test solution to precipitate blue precipitate.
- take about 5ml of this product, add 4 drops of dilute sulfuric acid, add 1 drop of 0.5% potassium permanganate solution, and the blue color of the solution will disappear.
- 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 this product, add a small amount of activated carbon decolorization, filtration, filtrate sodium salt identification (1) of the reaction (General rule 0301).
examination
- the pH value should be 3.5 to 4.5 (General 0631).
- Related substances take this product as a test solution; Take 2ml with precision, put it in a 100ml measuring flask, dilute to the scale with mobile phase, shake well, and use as a control solution. According to the chromatographic conditions under the content determination item, take 100 u1 of each of the test solution and the control solution, inject the human liquid chromatograph respectively, and record the chromatogram to 2 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 0.5 times (1.0%) 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%).
- take 50ml of heavy metal, put it on a water bath to dry, check according to law (General rule 0821 second law), containing no more than of heavy metals.
- The osmolality shall be 0632 ~ 320mOsmol/kg when the product is taken for inspection according to law (General rule 280).
- bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per lml should be less than 0.50EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take this product as a test solution, according to the chromatographic conditions under the content determination of mitoxantrone hydrochloride, take a precise amount of milk and inject a human liquid chromatograph, record the chromatogram; Take another reference substance of mitoxantrone hydrochloride, precision weighing, dissolved and quantitatively diluted with water to make a solution containing about 50ug per lml, the same method for determination. According to the external standard method to calculate the peak area, and the result is multiplied by 0.8591, that is.
category
fermented with mitoanthracene hydrochloride.
specification
100ml:5mg (based on C22H28N406)
storage
light shielding, closed storage.
Last Update：2022-01-01 15:04:08
Mitoxantrone hydrochloride - Mitoxantrone hydrochloride for injection
Authoritative Data Verified Data
- This product is a sterile freeze-dried product of mitoxantrone hydrochloride. Mitoxantrone hydrochloride, calculated as mitoxantrone (C22H28N406), shall be between 90.0% and 110.0% of the labeled amount.
- This product can be added with an appropriate amount of excipients.
trait
This product is a blue-black loose or amorphous solid; There is moisture.
identification
The same reaction was observed according to the tests of (1), (2) and (4) under mitoxantrone hydrochloride.
examination
- acidity: take this product and add water to make a solution containing 5mg of mitoxantrone per 1 ml, which is measured according to law (General rule 0631). The pH value should be 4.0~6.0.
- Related substances take this product, add mobile phase to dissolve and dilute to prepare a solution containing 1 mg of mitoxantrone per 1 ml, shake well, and use as a test solution, according to the method of related substances of mitoxantrone hydrochloride. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 1.5 times (1.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 3 times (3.0%) of the main peak area of the control solution.
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 5.0%, first method 1). The content uniformity of
- shall be calculated based on the content of each bottle measured under the content determination item, and shall comply with the regulations (General rule 0941).
- bacterial endotoxin take this product, according to the law inspection (General 1143), each 1 mg mitoxantrone Endotoxin content should be less than 5.0 EU.
- sterile take this product, add appropriate amount of sodium chloride injection to dissolve, then transfer it to of sodium chloride injection, treat it with membrane filtration method, and check it according to law (General rule 1101).
- others should comply with the relevant provisions under injection (General 0102).
Content determination
Take 10 bottles of this product, add water to dissolve each bottle and transfer to 50ml measuring bottle, wash the container with water, wash the bottle, dilute it to the scale with water, shake it, as the test solution, the content of each bottle was obtained by measuring the content of mitoxantrone hydrochloride according to the method under the item of measuring the content of mitoxantrone hydrochloride, and the content of each bottle was 0.8591, and the average content of 10 bottles was obtained.
category
with mitoxantrone hydrochloride.
specification
5mg (based on C22H28N406)
storage
light shielding, closed storage.
Last Update：2022-01-01 15:04:09
Supplier List
Multiple SpecificationsSpot supply
Product Name: Mitoxantrone dihydrochloride Visit Supplier Webpage Request for quotationCAS: 70476-82-3
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
Multiple SpecificationsSpot supply
Product Name: Mitoxantrone dihydrochloride Visit Supplier Webpage Request for quotationCAS: 70476-82-3
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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