Unlock instant, AI-driven research and patent intelligence for your innovation.
A kind of purification method of injection grade pemetrexed disodium
What is Al technical title?
Al technical title is built by PatSnap Al team. It summarizes the technical point description of the patent document.
A technology of pemetrexed disodium and purification method is applied in the purification field of injection grade pemetrexed disodium, and the purification work is simple and efficient, and the effect of solving the turbidity phenomenon is achieved.
Inactive Publication Date: 2016-04-27
WEIHAI HAOTONG MEDICAL SCI & TECH
View PDF18 Cites 0 Cited by
Summary
Abstract
Description
Claims
Application Information
AI Technical Summary
This helps you quickly interpret patents by identifying the three key elements:
Problems solved by technology
Method used
Benefits of technology
Problems solved by technology
[0009] In summary, there is a lack of an excellent method in the prior art to effectively remove various impurities in the API of pemetrexed disodium, so as to meet the requirements of drug registration for the impurity limit of the API
Method used
the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more
Image
Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
Click on the blue label to locate the original text in one second.
Reading with bidirectional positioning of images and text.
Smart Image
Examples
Experimental program
Comparison scheme
Effect test
Embodiment 1
[0030] Weigh 10 g of pemetrexed disodium crude product (HPLC purity 97.68%), add 20 mL concentration of 0.9% sodiumchloride aqueous solution to dissolve, if there is turbidity, add a little more until completely dissolved, extract twice with 30 mL of dichloromethane, Stand for stratification, collect and combine the water layer, heat the water layer to 30-40 o C, add 5% activated carbon, stir for 10-30 minutes, filter, add 20mL ethanol to the filtrate, stir to keep the temperature 30-40 o C, placed for 1-2 hours to crystallize, the filter cake was washed with 50% ethanol, and dried to obtain 8.78 g of pemetrexed disodium, with a purity of 99.73 and a maximum of 0.08%.
Embodiment 2
[0032] Take pemetrexed disodium crude product (HPLC purity 97.68%) 10g, add 30mL concentration and be 1.0% sodiumchloride aqueous solution to dissolve, if there is turbidity, can add a little bit more until completely dissolved, 30mL dichloromethane extraction twice, Stand for stratification, collect and combine the water layer, heat the water layer to 30-40 o C, add 3% activated carbon, stir for 10-30 minutes, filter, add 20mL ethanol to the filtrate, stir to keep the temperature 30-40 o C, placed for 1-2 hours to crystallize, the filter cake was washed with 50% ethanol, and dried to obtain 8.56 g of pemetrexed disodium, with a purity of 99.78 and a maximum of 0.07%.
Embodiment 3
[0034] Take pemetrexed disodium crude product (HPLC purity 97.68%) 10g, add 40mL concentration and be 2.0% sodium chloride aqueous solution to dissolve, if there is turbidity, can add a little more until fully dissolved, 40mL dichloromethane extraction twice, Stand for stratification, collect and combine the water layer, heat the water layer to 30-40 o C, add 1% activated carbon, stir for 10-30 minutes, filter, add 30mL ethanol to the filtrate, stir to keep the temperature 30-40 oC, placed for 1-2 hours to crystallize, the filter cake was washed with 50% ethanol, and dried to obtain 8.64 g of pemetrexed disodium, with a purity of 99.89 and a maximum of 0.05%.
the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More
PUM
Login to View More
Abstract
The invention provides a purification method of injection grade pemetrexed disodium. The method comprises the following steps: dissolving a pemetrexed disodium crude product in a sodiumchlorideaqueous solution, adding an organic solvent for extracting the aqueous solution, collecting the aqueous solution, adding active carbon, filtering, adding the organic solvent, separating out crystals, washing and drying. With the adoption of the purification method, the turbid phenomenon during a re-dissolution test can be effectively solved; more surprisingly, the purification method is capable of effectively removing impurities in the raw materialmedicine of pemetrexed disodium and simply and efficiently carrying out purification.
Description
technical field [0001] The invention relates to a purification method of injection-grade pemetrexed disodium, which belongs to the technical field of medicine. Background technique [0002] Pemetrexed disodium is a multi-targeted folate antagonist that inhibits thymidylate synthase (TS), dihydrofolate reductase (DHFR) and glycinamide ribonucleotide formyltransferase (GARFT) and other folate-dependent enzymes. Clinical trials have shown that pemetrexed disodium is effective for a variety of solid tumors. It is currently on the market in the United States, the European Union, China and other countries. It is used for the first-line treatment of malignant pleural mesothelioma and the second-line treatment of locally advanced and metastatic non-small celllungcancer. Pemetrexed disodium (Pemetrexeddisodium, structural formula as shown below), chemical name: N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2 ,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid disodium salt. [00...
Claims
the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More
Application Information
Patent Timeline
Application Date:The date an application was filed.
Publication Date:The date a patent or application was officially published.
First Publication Date:The earliest publication date of a patent with the same application number.
Issue Date:Publication date of the patent grant document.
PCT Entry Date:The Entry date of PCT National Phase.
Estimated Expiry Date:The statutory expiry date of a patent right according to the Patent Law, and it is the longest term of protection that the patent right can achieve without the termination of the patent right due to other reasons(Term extension factor has been taken into account ).
Invalid Date:Actual expiry date is based on effective date or publication date of legal transaction data of invalid patent.
Login to View More 
Login to View More