Mitomycin
Mitomycin
CAS: 50-07-7
Molecular Formula: C15H18N4O5
Mitomycin - Names and Identifiers
| Name | Mitomycin |
| Synonyms | Mitomycin Mitomycin C Mitomycin C, Streptomyces caespitosus mitomycin C from streptomyces*caespitosus |
| CAS | 50-07-7 |
| EINECS | 200-008-6 |
| InChI | InChI=1/C15H18N4O5/c1-5-9(16)12(21)8-6(4-24-14(17)22)15(23-2)13-7(18-13)3-19(15)10(8)11(5)20/h6-7,13,18H,3-4,16H2,1-2H3,(H2,17,22)/t6-,7?,13+,15-/m0/s1 |
Mitomycin - Physico-chemical Properties
| Molecular Formula | C15H18N4O5 |
| Molar Mass | 334.327 |
| Density | 1.56g/cm3 |
| Melting Point | 360℃ |
| Boling Point | 581.8°C at 760 mmHg |
| Flash Point | 305.6°C |
| Water Solubility | soluble |
| Vapor Presure | 1.59E-13mmHg at 25°C |
| Appearance | Shape powder, color blue-gray |
| pKa | pKa 2.8(H2O,t =25,I=0.1) (Uncertain) |
| PH | pH (0.5 g/l, 25℃ : )5.0～7.0 |
| Storage Condition | 2-8°C |
| Stability | Stable. Incompatible with strong acids, strong bases, strong oxidizing agents. |
| Refractive Index | 1.68 |
| Physical and Chemical Properties | Melting point 360°C water-soluble soluble |
| Use | Anticancer drugs, commonly used to treat cancers of the digestive system |
Mitomycin - Risk and Safety
| Hazard Symbols | T - Toxic |
| Risk Codes | R25 - Toxic if swallowed R40 - Limited evidence of a carcinogenic effect |
| Safety Description | S36/37 - Wear suitable protective clothing and gloves. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) |
| UN IDs | UN 3462 6.1/PG 2 |
| WGK Germany | 3 |
| RTECS | CN0700000 |
| FLUKA BRAND F CODES | 8-10 |
| TSCA | Yes |
| HS Code | 29419090 |
| Hazard Class | 6.1(a) |
| Packing Group | II |
| Toxicity | LD50 i.v. in mice: 5 mg/kg (Wakaki); also reported as 9 mg/kg (Kinoshita) |
Mitomycin - Upstream Downstream Industry
| Raw Materials | Dichloromethane streptomyces avermifilis HAM'S F10-MEDIUM |
| Downstream Products | Mitomycin A |
Mitomycin - Standard
Authoritative Data Verified Data
This product is 6-amino -1,la,2,8,8a ,8b-hexahydro-8-(by methyl)-8a-methoxy-5-methylaziridine [2 ',3':3,4] pyrrolo [1,2-a] Indole -4, 7-dione carbamate. Calculated as dry product, containing mitomycin (C15H18N405) shall not be less than 97.0%.
Last Update：2024-01-02 23:10:35
Mitomycin - Trait
Authoritative Data Verified Data
- This product is dark purple crystalline powder; Odorless; Unstable when exposed to acid, alkali and sunlight.
- This product is slightly soluble in water, methanol or ethanol, and almost insoluble in ether.
Last Update：2022-01-01 11:43:18
Mitomycin - Differential diagnosis
Authoritative Data Verified Data
- take this product, add water to dissolve and dilute to make a solution containing 10ug per lml, and measure by UV-Vis spectrophotometry (General 0401), there is a maximum absorption at a wavelength of 217nm and 365nm.
- 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 918).
Last Update：2022-01-01 11:43:18
Mitomycin - Exam
Authoritative Data Verified Data
crystallinity
take a small amount of this product, according to the law inspection (General 0981), should comply with the provisions.
pH
take this product, add water to make a suspension containing 5mg per lml, according to the law (General 0631), pH value should be 5.5~7.5.
Related substances
take an appropriate amount of this product, add methanol to dissolve and dilute to prepare a solution containing 2mg per lml as a test solution; Take an appropriate amount for precision measurement, A solution containing log per 1 ml was prepared as a control solution by quantitative dilution with methanol. According to the determination by high performance liquid chromatography (General 0512), silica gel bonded with eighteen alkyl silane was used as filler; 0.077% ammonium acetate solution-methanol (80:20) was used as mobile phase A; the mobile phase B was 0.077% ammonium acetate solution-methanol (50:50), and the linear gradient elution was carried out according to the following table. The detection wavelength was 254nm, and the column temperature was 30°C. Separately take the appropriate amount of cinnamamide and mitomycin, add methanol to dissolve and dilute to prepare a mixed solution containing about 0.08mg and 0.2mg per 1 mL respectively as the applicable solution for the system, inject into the liquid chromatograph, record the chromatogram, the retention time of the mitomycin peak is about 21 minutes, the relative retention time of the cinnamamide peak is about 1.3, and the separation degree between the mitomycin peak and the cinnamamide peak should be greater than 15.0. The test solution and the control solution were respectively injected into the human liquid chromatograph, and the chromatograms were recorded. If there are impurity peaks in the chromatogram of the test solution, the cinnamamide peak shall be calculated according to the corrected peak area (multiplied by the correction factor of 0.35) and shall not be larger than the main peak area of the control solution (0.5% ) , the Peak area of other single impurity shall not be greater than the main peak area of the control solution (0.5% ) , and the sum of the peak areas of each impurity shall not be greater than 4 times (2.0%) of the main peak area of the control solution calculated by the corrected peak area, the peaks in the chromatogram of the test solution which were 0.1 times smaller than the main peak area of the control solution were ignored.
loss on drying
take this product, with phosphorus pentoxide as desiccant, at 60°C under reduced pressure drying to constant weight, weight loss should not exceed 2.0% (General rule 0831).
bacterial endotoxin
take this product, check according to law (General rule 1143), the amount of endotoxin in mitomycin per 1 mg should be less than 10EU. (For injection)
Last Update：2022-01-01 11:43:19
Mitomycin - 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 the filler, and 0.077% ammonium acetate solution-methanol (70:30) was used as the mobile phase; The detection wavelength was 365nm; take the system applicable solution 5 u1 under the relevant substances inspection item, inject the human liquid chromatograph, record the chromatogram, and the separation degree between the mitomycin peak and the cinnamamide peak shall meet the requirements, the tailing factor of the mitomycin peak should not be greater than 1.3.
assay
take an appropriate amount of this product, accurately weigh it, add methanol to dissolve and dilute it to make a solution containing about 0.2mg per lml, as a test solution, and inject 5ul into the liquid chromatograph with precise amount, record the chromatogram; Take the appropriate amount of mitomycin control, with the same method, according to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 11:43:20
Mitomycin - Category
Authoritative Data Verified Data
Anti-tumor antibiotics.
Last Update：2022-01-01 11:43:20
Mitomycin - Storage
Authoritative Data Verified Data
sealed and kept in cool and dark place.
Last Update：2022-01-01 11:43:20
Mitomycin - Mitomycin for Injection
Authoritative Data Verified Data
This product is a sterile powder made of mitomycin and sodium chloride as excipient. The mitomycin (C15H18N405) content shall be between 90.0% and 110.0% of the labeled amount.
trait
This product is cyan powder or gray-purple freeze-dried powder; Unstable in light.
identification
take the product, according to the identification of mitomycin item (1), (2) test, showed the same results.
examination
- pH value take this product, add water to make a solution containing 0631 mg of mitomycin per lml, and determine it according to law (General Rule 5.5). The pH value should be 8.5.
- Related substances take 1 bottle of this product, add methanol to dissolve and dilute to make a solution containing 2mg of mitomycin per 1 ml, and determine it according to the method under the item of mitomycin, and it should comply with the regulations.
- loss on drying: take about 0.2g of this product, use phosphorus pentoxide as desiccant, dry under reduced pressure at 60°C to constant weight, and lose no more than 1.0% of weight (General rule 0831).
- Content uniformity take 10 bottles of this product, and compare the content of each bottle measured by the method under the content determination item with the average content, the difference of ± 15% shall not be more than 1 bottle, it should not exceed ± 20%.
- bacterial endotoxin should be checked according to the method under the item of mitomycin, and it should be in accordance with the regulations.
- 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.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
Take 10 bottles of this product, add dimethyl acetamide to dissolve and quantitatively dilute according to the marked amount to make a solution containing about 0.2mg per lml, as the test solution, according to the method under the item of mitomycin, the content of each bottle was measured, and the average content of 10 bottles was obtained.
category
with mitomycin.
specification
(l)2mg (2)4mg (3)8mg (4)10mg
storage
light shielding, closed storage.
Last Update：2022-01-01 11:43:21
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