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Active Pharmaceuticals

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Product Name Levomefolate Calcium / L-5-Methyltetrahydrofolate / L-5-MTHF Ca
CAS 151533-22-1
Aspectus Lumine albo flavo pulveris
Formulae hypotheticae C20H23CaN7O6
M. Pondus 497.52
Assay 98%

L-5-Methyltetrahydrofolate calcium 151533-22-1 is a naturally occurring salt forming methyl derivative of folate. 5-mthf, also known as l-methylfolate, is the most biologically active and functional form of folate and is more easily absorbed than folate.Common folate must be converted to l-methylfolate in order to participate in the two main metabolic pathways: methylation and DNA synthesis. The only form of free folate present in human plasma and cells is 5-mthf.Deficiency of folic acid is usually caused by insufficient absorption due to vitamin deficiency. Folic acid needs to be increased during pregnancy and breast-feeding, as well as during childhood growth. Folate-rich food cannot guarantee the dose provided by absorption or metabolic changes or drugs, so it needs to be supplemented.

1. L-5-MTHF Ca is Mainly for folic acid antagonists (such as methotrexate, pyrimethamine, benzyl cefalexin and trimethoprim) antidote, it's usually used for prevention of methotrexate dose or overdose treatment caused severe toxic effects.

2. L-5-MTHF Ca is used for Folic acid treatment of the following diseases, such as inflammatory diarrhea
and protein-energy malnutrition (poor nutrition), pregnancy or infancy megaloblastic anemia caused by poor.

3. L-5-MTHF Ca as adjuvant therapy for colon cancer, rectal cancer.

4. Combined with 5-FU and treatment of digestive tract tumors or other 5-FU-sensitive tumors.High-dose CF used in conjunction with 5-FU (LF), the basic programme is currently the treatment of colon and rectal cancer.

5. L-5-MTHF Ca is used For children with leukemia, lymphoma, and osteosarcoma, such as high dose MTX treatment when rescued.

Item Specification Test Results
Aspectus White or off-white crystalline powder Conforms
Lepidium sativum HNMR,HPLC Conforms
Imprimis Rotationes[a]25D(C=1.5% in water) USP +45.07°
Calcium content(on dry basis ) 7.0%~8.5% 7.3%
D-5-Methylfolate ≤1.0% Conforms
Water cotent(KF) ≤16.0% 15.68%
Single impurity ≤1.0% <0.41%
Total Impurites ≤2.5% 1.45%
Residual solvent(Ethanol) ≤5000ppm Not detected
Chloride(CI*) ≤0.5% Conforms
Arsenic(As) ≤1ppm <1ppm
Metalla gravis ≤20ppm <20ppm
Boron ≤20ppm Conforms
Total plate count ≤100cfu/g Conforms
Yeast and Mold ≤100cfu/g Not detected
Salmonella Negative Conforms
E.Coli Negative Conforms
Assay(on dry basis) >98.0% 99.10%

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