Etoposide for system suitability
Etoposide
CAS: 33419-42-0
Molecular Formula: C29H32O13
Etoposide for system suitability - Names and Identifiers
| Name | Etoposide |
| Synonyms | Etoposide Etoposide for system suitability BMY-40481, Etoposide 4'-Dihydrogenphosphate, VP-16-213 4-demethylepipodophyllotoxin-beta-d-ethylideneglucoside 4'-demethylepipodophyllotoxin-(4,6-o-(r)-ethylidene-beta-d-glucopyranoside) GAL4 [(1-147) + VP16 (411-490)] from Saccharomyces cerevisiae human herpesvirus 2 |
| CAS | 33419-42-0 |
| EINECS | 251-509-1 |
| InChI | InChI=1/C29H32O13/c1-11-36-9-20-27(40-11)24(31)25(32)29(41-20)42-26-14-7-17-16(38-10-39-17)6-13(14)21(22-15(26)8-37-28(22)33)12-4-18(34-2)23(30)19(5-12)35-3/h4-7,11,15,20-22,24-27,29-32H,8-10H2,1-3H3/t11-,15-,20-,21+,22-,24+,25-,26+,27+,29-/m0/s1 |
Etoposide for system suitability - Physico-chemical Properties
| Molecular Formula | C29H32O13 |
| Molar Mass | 588.56 |
| Density | 1.2966 (rough estimate) |
| Melting Point | 236-251 °C (lit.) |
| Boling Point | 563.9°C (rough estimate) |
| Specific Rotation(α) | D20 -110.5° (c = 0.6 in chloroform) |
| Flash Point | 263.603°C |
| Water Solubility | Insoluble in water. |
| Solubility | Almost insoluble in water, slightly soluble in methanol and dimethyl sulfoxide, slightly soluble in ethanol. |
| Vapor Presure | 0mmHg at 25°C |
| Appearance | White powder or crystal |
| Color | white |
| Merck | 14,3886 |
| pKa | 9.8(at 25℃) |
| Storage Condition | 2-8°C |
| Stability | Stable for 2 years from date of purchase as supplied. Solutions in DMSO may be stored at -20°C for up to 2 months |
| Refractive Index | -110.5 ° (C=0.6, CHC |
| MDL | MFCD00869325 |
| Physical and Chemical Properties | Melting point 236-251°C |
| Use | Used as an antineoplastic agent |
| Target | Topo II (Cell-free assay) |
Etoposide for system suitability - Risk and Safety
| Risk Codes | R45 - May cause cancer R22 - Harmful if swallowed R36/37/38 - Irritating to eyes, respiratory system and skin. |
| Safety Description | S53 - Avoid exposure - obtain special instructions before use. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36/37 - Wear suitable protective clothing and gloves. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. |
| UN IDs | 3249 |
| WGK Germany | 3 |
| RTECS | KC0190000 |
| HS Code | 29389090 |
| Hazard Class | 6.1(a) |
| Packing Group | II |
| Toxicity | LD50 oral in rabbit: 147mg/kg |
Etoposide for system suitability - Reference
| Reference Show more | 1. Wu Jingchuan, Li Hui, He Junchi, et al. Changes and significance of miRNA-9 expression in rat brain tissue after traumatic brain injury [J]. Journal of Third Military Medical University 2017 39(014):1458-1463. 2. Huixia Feng et al. [IF = 5.81]. "Exploring Multifunctional Bioactive Components from podopillum sinense Using Multi-Target Ultrafiltration." Front Pharmacol. 2021; 12: 749189 |
Etoposide for system suitability - Standard
Authoritative Data Verified Data
This product is 9-[4,6-0-(R)-ethylene-B-D-glucopyranoside; HZ-demethylated white toxin. The C29H32013 content shall be 95.0% to 103.0% based on the water-free content.
Last Update：2024-01-02 23:10:35
Etoposide for system suitability - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Odorless, with hygroscopicity.
- This product is slightly soluble in acetone, slightly soluble in methanol or three gas methane, very slightly soluble in ethanol, almost insoluble in water.
specific rotation
take this product, precision weighing, plus three gas methane-methanol (9:1) dissolved and quantitatively diluted to make a solution containing about 5mg per lm l, measured according to law (General rule 0621), the specific rotation is from one 110 ° to one 118 °..
Last Update：2022-01-01 13:36:09
Etoposide for system suitability - Introduction
Etoposide is a semi-synthetic derivative of podophyllotoxin, which inhibits DNA synthesis by inhibiting topoisomerase II activity.
Last Update：2022-10-16 17:24:42
Etoposide for system suitability - Differential diagnosis
Authoritative Data Verified Data
- take an appropriate amount of this product, add 1 ml of methanol to dissolve, add several drops of 10% a-naphthol methanol solution, mix well, carefully add 2ml of sulfuric acid along the wall, and produce purple brown ring at the interface of the two liquids.
- 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 615).
Last Update：2022-01-01 13:36:09
Etoposide for system suitability - Exam
Authoritative Data Verified Data
clarity and color of solution
take 0.30g of this product, add dichloromethane-methanol (9:1) mixed solution of 10ml dissolved, the solution should be clear and colorless. In case of color development, it shall not be deeper in comparison with the yellow No. 1 Standard Colorimetric solution (General rules 0901 first method).
Related substances
take this product, add mixed solvent [acetonitrile-acetate buffer (take sodium acetate 5.44g, dissolve and dilute to 4.0 with water, adjust pH to with glacial acetic acid)(30:70)] dissolve and dilute to prepare a solution containing about 2mg per 1ml, and take an appropriate amount of propyl paraben as a test solution, add a mixed solvent, dissolve and dilute to prepare a solution containing about 0.2mg per 1ml, and take 1ml, in a 200ml measuring flask, 1ml of human test solution was added precisely, diluted to a scale with a mixed solvent, and shaken to obtain a control solution. According to the high performance liquid chromatography (General 0512) test, with phenyl silane bonded silica gel as filler, acetonitrile-salt buffer (20:80) as mobile phase A, acetonitrile-acetate buffer (60:40) was used as mobile phase B; Gradient elution was carried out as follows; Detection wavelength was 254nm. The retention time of the etoposide peak is about 25 minutes, and the degree of separation of the etoposide peak from the propyl paraben peak should be satisfactory. 20ul of the test solution and the control solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded for 40 minutes. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be more than 2 times (1.0%) the area of etoposide peak in the control solution, the sum of each impurity peak area must not be greater than 4 times (2.0%) the area of the etoposide peak in the control solution.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 6.0%.
ignition residue
take 1.0g of this product and check it according to law (General rule 0841). The remaining residue shall not exceed 0.1%.
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 13:36:10
Etoposide for system suitability - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
A phenyl silane bonded silica gel was used as a filler; Acetonitrile-acetate buffer (pH 4.0)(30:70) was used as a mobile phase; The detection wavelength was 254mn. The number of theoretical plates is not less than 3000 calculated from the peak of etoposide.
assay
take an appropriate amount of this product, accurately weigh it, dissolve it with mobile phase and quantitatively dilute it to make a solution containing about 0.2mg per 1 ml as a test solution, A 20ul injection liquid chromatograph was used for precise measurement, and the chromatogram was recorded. Another reference substance of etoposide was used for determination by the same method. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 13:36:11
Etoposide for system suitability - Category
Authoritative Data Verified Data
antineoplastic agents.
Last Update：2022-01-01 13:36:11
Etoposide for system suitability - Storage
Authoritative Data Verified Data
light-shielded, sealed, and stored in a dry place.
Last Update：2022-01-01 13:36:11
Etoposide for system suitability - Etoposide Soft Capsules
Authoritative Data Verified Data
This product contains etoposide (C29H32013) should be labeled amount of 90.0% ~ 110.0%.
trait
This product is a soft capsule, the content of colorless to light yellow clear viscous liquid.
identification
- take an appropriate amount of the contents of this product (about 40mg equivalent to etoposide), add 1 ml of methanol to dissolve, add several drops of 10% a-naphthol methanol solution, mix well, carefully add 2ml of sulfuric acid along the wall, purple-brown rings were generated at the interface of the two liquid layers.
- 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
- the contents under the item of difference in loading of related substances are suitable for children (about 50mg equivalent to etoposide), precision weighed and placed in a 25ml measuring flask, add mixed solvent [acetonitrile-acetate buffer solution (take sodium acetate 5.44G with water to dissolve and dilute to 4.0, adjust pH to with glacial acetic acid)(30:70)] to dissolve etoposide and dilute to the scale, shake well, as a test solution; Take an appropriate amount of P-hydroxyphenyl methyl propyl ester, add a mixed solvent to dissolve and dilute to make a solution containing about 0.2mg per 1ml, take 1ml, put it in a 200ml measuring flask, then, 1ml of the test solution was added precisely, diluted to a scale with a mixed solvent, and shaken to serve as a control solution. According to the method of etoposide related substances. If there are impurity peaks in the chromatogram of the test solution, the sum of the peak areas of each impurity shall not be more than 6 times (3.0%) of the peak area of etoposide in the control solution.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
take an appropriate amount of content (about equivalent to etoposide 20mg) under the difference of loading amount, weigh it accurately, put it in a 100ml measuring flask, dilute it to the scale with mobile phase, shake it well, as the test solution, 20 u1 was accurately measured and measured according to the method under the item of etoposide content measurement.
category
with etoposide.
specification
50mg
storage
shading, sealing, storage in cold place.
Last Update：2022-01-01 13:36:12
Etoposide for system suitability - Etoposide injection
Authoritative Data Verified Data
This product is a sterile solution of etoposide with polyethylene glycol 400 and anhydrous ethanol as a mixed solvent. Etoposide-containing (C29H32013) shall be between 90.0% and 110.0% of the labeled amount.
trait
This product is colorless to light yellow clear liquid.
identification
- Take 2ml of this product, add several drops of 10% a-naphthol methanol solution, mix well, carefully add 2ml sulfuric acid along the wall to produce purple brown rings at the interface of the two liquid layers,
- 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
The pH value of this product is 5ml, add water 45ml, mix well, and determine according to law (General 0631), it should be 3.0~4.0.
Color
take this product, and yellow 3 Standard Colorimetric liquid (General 0901) comparison, not deeper.
Related substances
- take an appropriate amount of this product with a mixed solvent [acetonitrile-gallate buffer (take sodium acetate 5.44G and dilute to 4.0 with water, adjust the pH value to with glacial acetic acid)(30:70)] Diluted to prepare solution t containing 2mg per lml as the test solution; In addition, take an appropriate amount of propyl paraben, add a mixed solvent to dissolve and dilute to prepare a solution containing about 0.2mg per lml, take 1ml, put it in a 200ml measuring flask, add 1ml of human test solution precisely, dilute to the scale with mixed solvent, shake well, and serve as a control solution. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be more than 6 times (3.0%) the area of the etoposide peak in the control solution..
- the bacterial endotoxin of this product is determined according to law (General rule 1143), and the amount of endotoxin per 1 mg of etoposide should be less than 2.0EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
precision children take an appropriate amount of this product and dilute it with mobile phase to make a solution containing 0.2mg per lml as a test solution, and take 20 u1 for precision measurement, according to the method under the determination of etoposide content, it is obtained.
category
with etoposide.
specification
(l)2ml:40mg (2)5ml:lOOmg
storability
light shielding, closed storage.
Last Update：2022-01-01 13:36:13
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tech@medchemexpress.com
Mobile: 609-228-6898
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Product Name: Etoposide Request for quotationCAS: 33419-42-0
Tel: 400-968-2212
Email: 3623107365@qq.com
Mobile: 18916960931
QQ: 3623107365
Wechat: 18916960931
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Tel: +86-400-900-4166
Email: product@acmec-e.com
Mobile: +86-18621343501
QQ: 2881950922
Wechat: 18621343501
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Product Name: Etoposide Visit Supplier Webpage Request for quotationCAS: 33419-42-0
Tel: +16314854226
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Tel: +86 0571-86722205
Email: sales@chinaskyrun.com
Mobile: +8618958170122
QQ: 2531159185
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Multiple SpecificationsSpot supply
Product Name: Etoposide Visit Supplier Webpage Request for quotationCAS: 33419-42-0
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
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