Ifosfamide
Ifosfamide
CAS: 3778-73-2
Molecular Formula: C7H15Cl2N2O2P
Ifosfamide - Names and Identifiers
| Name | Ifosfamide |
| Synonyms | Ifex Cyfos Z4942 A 4942 Holoxan Naxamide MJF 9325 Mitoxana Ifosfamid 3778-73-2 Ifosfamide Isoendoxan Asta Z 4942 Iphosphamid Holoxan 1000 Isofosfamide Isophosphamide Iphosphamid(e) 2,3-N,N(sup 1)-Bis(2-chloroethyl)diamido-1,3,2-oxazaphosphoridinoxy- N,3-Bis(2-chloroethyl)tetrahydro-2H-1,3,2-oxazaphosphorin-2-amine 2-oxide N-(2-Chloroethyl)-N'-(2-chloroethyl)-N',O-propylenephosphoric acid diamide 2H-1,3,2-Oxazaphosphorin-2-amine, N,3-bis(2-chloroethyl)tetrahydro-, 2-oxide N-(2-Chloroethyl)-N'-(2-chloroethyl)-N',O-propylene phosphoric acid ester diamide 3-(2-Chloroethyl)-2-[(2-chloroethyl)amino]perhydro-2H-1,3,2-oxazaphosphorineoxide 3-(2-Chloroethyl)-2-[(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide 1,3,2-Oxazaphosphorine, 3-(2-chloroethyl)-2-[(2-chloroethyl)amino]tetrahydro-, 2-oxide |
| CAS | 3778-73-2 |
| EINECS | 223-237-3 |
| InChI | InChI=1/C7H15Cl2N2O2P/c8-2-4-10-14(12)11(6-3-9)5-1-7-13-14/h1-7H2,(H,10,12) |
Ifosfamide - Physico-chemical Properties
| Molecular Formula | C7H15Cl2N2O2P |
| Density | 1.33±0.1 g/cm3(Predicted) |
| Melting Point | 39-41 °C |
| Boling Point | 336.1±52.0 °C(Predicted) |
| pKa | 1.44±0.20(Predicted) |
| Storage Condition | 2-8℃ |
| MDL | MFCD00057374 |
| Physical and Chemical Properties | Melting Point 48°C |
| Use | For the treatment of malignant lymphoma, lung cancer, breast cancer, esophageal cancer, bone and soft tissue sarcoma, non-small cell lung cancer, head and neck cancer, cervical cancer |
Ifosfamide - Standard
Authoritative Data Verified Data
This product is 3-(2-chloroethyl)-2-[(2-chloroethyl) amino] tetrahydro-2h-l, 3, 2-oxazaphosphora cyclohexane -2-oxide. The content of C7H15C12N202P shall be between 98.0% and 102.0%, calculated as anhydrous.
Last Update：2024-01-02 23:10:35
Ifosfamide - Trait
Authoritative Data Verified Data
- This product is a white crystalline powder; Odorless; Has a strong hygroscopicity.
- This product is soluble in water or ethanol, dissolved in chloroform, slightly soluble in acetone.
Last Update：2022-01-01 11:54:36
Ifosfamide - 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 the spectrum of the control (Spectrum set 1138).
Last Update：2022-01-01 11:54:36
Ifosfamide - Exam
Authoritative Data Verified Data
acidity
take L. 0g of this product, Add 10ml of water to dissolve, immediately determine according to law (General rule 0631),pH value should be 4.0~7.0. The clarity and color of the solution take this product l. After adding 10ml of water to dissolve, the solution should be clear and colorless; If it is turbid, it should not be more concentrated compared with No. 1 turbidity standard solution (General 0902 first method).
Related substances
take about 30mg of this product, weigh it accurately, put it in a 10ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, and use it as a test solution. Take 1ml of precision, 100ml flask, diluted with mobile phase to scale, shake, as a control solution. Take another 3-(2-chloroethyl)-2-[(2-chloropropyl) amino] tetrahydro, 3, 2-oxazaphosphora cyclohexane -2-oxide (impurity I) about 15mg of reference substance was accurately weighed, placed in a 50ml measuring flask, dissolved with acetonitrile and diluted to scale, then shaken well, accurately weighed 1ml, placed in a 10ml measuring flask, and diluted to scale with acetonitrile, as a stock solution (1); Take 3-(2-chloroacetyl)-2-[(2-chloroethyl) amino] tetrahydro-2-h-1, 3, about 15mg of 2-oxazaphosphazine-2-oxide (impurity II) reference, precision weighing, put it in a 50ml measuring flask, dissolve with acetonitrile and dilute to scale, shake well, take 1ml in a 10ml measuring flask, dilute to the scale with acetonitrile, shake well, and use it as a stock solution (2); Take about 30mg of Ifosfamide Control product, and weigh it accurately, in a 10ml measuring flask, 1ml of each of the stock solution (1) and the stock solution (2) was added precisely, diluted to the scale with the mobile phase, and shaken to obtain a reference solution. According to the chromatographic conditions under the content determination item, the reference solution 20u1 was injected into the human liquid chromatograph, and the chromatogram was recorded to 2.5 times of the retention time of the main component peak. The order of peaks was impurity II, ifosfamide and impurity I; The separation degree between impurity II peak, ifosfamide peak and impurity I peak shall meet the requirements, and the number of theoretical plates shall not be less than 800 based on ifosfamide peak; then 20 u1 of the test solution and the control solution are accurately measured, and eight liquid chromatographs are injected respectively, and the chromatogram is recorded to 2.5 times of the retention time of the main component peak, if there are impurity peaks at the corresponding positions of impurity I peak and impurity n peak in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and shall not exceed 0.1%, the Peak area of other individual impurities shall not be greater than 0.1 times (0.1%) of the main peak area of the control solution, and the total amount of impurities shall not exceed 1.0%.
oxygen ion
take this product 2.0g, precision weighing, add water 15ml dissolved, precision plus 0.06% sodium chloride solution 10ml, add glacial acetic acid 2ml, according to the potential titration method (General 0701), with silver nitrate titration solution (0.Olmol/L) titration, and the results of the titration were corrected with a blank test. This product per lg consumption of silver nitrate titration solution (0.Olmol/L) should not exceed 0.5 (0.018%).
phosphorus content
take this product l. Add water to dissolve in 100ml measuring flask and dilute to the scale. Shake well and take 10ml of precision measurement. Add 5ml of water and 15ml of chloroform into the separating funnel, strong shaking for 30 seconds, static to make the layer, discard the chloroform layer, and then repeated shaking extraction with chloroform 4 times, 15ml each time, all discard the chloroform layer, take the water layer, put the Erlenmeyer flask, wash the separatory funnel with water twice, 5ml each time, combine the washing solution into the Erlenmeyer flask, add 3ml sulfuric acid, heat until white smoke appears, remove the heater, carefully add 0.6 concentrated hydrogen peroxide solution, re-heating until white smoke appears, if the solution has color, repeat the above operation, add concentrated hydrogen peroxide solution and heat until the color disappears, let cool, add 25ml of water and 2 drops of phenolphthalein indicator, Add concentrated ammonia solution or hydrochloric acid Dropwise until the solution is neutral, transfer the solution to a 100ml measuring flask, dilute with water to scale, shake well, and use it as a test solution. Take 0.1824g of potassium dihydrogen phosphate by precision weighing, put it in a 1000ml measuring flask, add water to dissolve and dilute to the scale, shake well, take 1ml accurately, put it in a 100ml measuring flask, dilute it to the scale with water, shake well, and use it as a reference solution. Take 15ml of test solution and 15ml of reference solution respectively, put them in 25ml measuring flask, and add ammonium molybdate solution (take 2.5g of ammonium molybdate, Add 30ml of water to dissolve, add 20ml of 37.5% sulfuric acid solution, shake) 2.5ml, shake, place for 30 seconds, then add hydroquinone solution (take hydroquinone 0.5g, add water 100ml to dissolve, add sulfuric acid 1 drop, shake. If the solution turns dark brown, it should be reconstituted) 20% ml with freshly prepared 2.5 sodium sulfite solution, dilute with water to the scale, shake well, and place for 30 minutes, according to ultraviolet-visible spectrophotometry (General rule 0401), absorbance was measured at a wavelength of NM, and calculated. Phosphorus content shall not exceed 0.0415%.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 0.3%.
Heavy metals
take l.Og of this product, add 23ml of water to dissolve, add 2ml of acetate buffer (pH 3.5), and check according to law (General rule 0821 first law), containing heavy metals not more than 20 parts per million.
Last Update：2022-01-01 11:54:38
Ifosfamide - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
The theoretical plate number calculated from the ifosfamide peak was not less than 800 using octadecylsilane-bonded silica gel as a filler; Acetonitrile-water (30:70) as a mobile phase; And the detection wavelength was 195nm.
assay
take this product, precision weighing, add mobile phase dissolution and quantitative dilution to make a solution containing about 0.6mg per 1 ml, as a test solution, precision volume of 20ul injection of human liquid chromatography, the chromatogram was recorded; The reference substance of ifosfamide 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 11:54:38
Ifosfamide - Category
Authoritative Data Verified Data
antineoplastic agents
Last Update：2022-01-01 11:54:39
Ifosfamide - Storage
Authoritative Data Verified Data
shading, sealing, storage in cold place.
Last Update：2022-01-01 11:54:39
Ifosfamide - Lfosfamide for Injection
Authoritative Data Verified Data
This product is a sterile freeze-dried product made of ifosfamide plus appropriate excipients. Ifosfamide (C7H15C12N202P) should be included in 90.0% to 110.0% of the labeled amount, calculated as the average loading.
trait
This product is white or off-white loose block or powder.
identification
- take an appropriate amount of this product (about 50mg equivalent to ifosfamide), add 2.5 of ethanol, shake to dissolve ifosfamide, filter, and take the filtrate as the test solution, ethanol was added to prepare a solution containing about 20mg per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb 10 u1 of each of the above two solutions, respectively point on the same silica gel G thin layer plate, with isopropanol-toluene (1:1) as the developing solvent, expand, dry, set iodine vapor in the color, for the test solution of the main spot position and color should be the same as the reference solution of the main spot.
- 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.
examination
- acidity take this product, add water to dissolve and make a solution containing about 0.lg of ifosfamide per 1 ml, and determine it according to law (General rule 0631). The pH value should be 4.0~7.0.
- the clarity and color of the solution: Take 1 bottle of this product, Add 10ml of water to dissolve, the solution should be clear and colorless; If it is turbid, compare it with No. 1 turbidity standard solution (General rule 0902 first method), not more concentrated.
- relevant substances: take an appropriate amount of this product (about equivalent to ifosfamide 30/mg), weigh it accurately, put it in a 10ml measuring flask, dissolve it with mobile phase, dilute it to the standard, and shake it well, as a test solution. Take 1 ml accurately, put it in a 100ml measuring flask, dilute it to the scale with mobile phase, shake it well, and use it as a control solution. According to ifosfamide related substances under the determination of the method. If there are impurity peaks at corresponding positions of impurity I peak and impurity n peak in the chromatogram of the test solution, the peak area shall not be greater than that of corresponding components in the reference solution (0.1% ) , other single impurity peak area shall not be greater than 0.1 times (0.1%) of the main peak area of the control solution, and the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 2.0%, first method 1).
- the bacterial endotoxin of this product is taken and checked according to law (General rule 1143). The amount of endotoxin contained in ifosfamide per 1 mg should be less than 0.10EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take the contents under the difference of loading amount, mix evenly, weigh an appropriate amount (about 15mg equivalent to ifosfamide) accurately, put it in a 25ml measuring flask, add the mobile phase to dissolve and dilute to the scale, as a test solution. According to the method under the item of ifosfamide content determination, it is obtained.
category
Same as ifosfamide
specification
(1)0.5g (2)1.Og
storage
shading, sealing, storage in cold place.
Last Update：2022-01-01 11:54:40
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Spot supply
Product Name: Ifosfamide Visit Supplier Webpage Request for quotationCAS: 3778-73-2
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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