Y0002071

Calcium folinate for system suitability

European Pharmacopoeia (EP) Reference Standard

• Synonym(s): Folinic acid calcium salt hydrate, 5-Formyl-5,6,7,8-tetrahydrofolic acid calcium salt, 5-Formyl-5,6,7,8-tetrahydropteroyl-L-glutamic acid calcium salt, 5-HCO-H₄PteGlu, Calcium folinate, Citrovorum factor calcium salt, Leucovorin calcium salt
• Empirical Formula (Hill Notation): C₂₀H₂₁CaN₇O₇ · xH₂O
• CAS Number: 1492-18-8
• Molecular Weight: 511.50 (anhydrous basis)
• Beilstein/REAXYS Number: 5723924
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• biological source: synthetic
• grade: pharmaceutical primary standard
• agency: EP
• API family: folic acid
• form: solid
• manufacturer/tradename: EDQM
• technique(s): gas chromatography (GC): suitable; liquid chromatography (LC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: −20°C
• SMILES string: [Ca++].[H]O[H].[H]C(=O)N1C(CNc2ccc(cc2)C(=O)N[C@@H](CCC([O-])=O)C([O-])=O)CNc3nc(N)nc(O)c13
• InChI: 1S/C20H23N7O7.Ca/c21-20-25-16-15(18(32)26-20)27(9-28)12(8-23-16)7-22-11-3-1-10(2-4-11)17(31)24-13(19(33)34)5-6-14(29)30;/h1-4,9,12-13,22H,5-8H2,(H,24,31)(H,29,30)(H,33,34)(H4,21,23,25,26,32);/q;+2/p-2/t12?,13-;/m0./s1
• InChI key: KVUAALJSMIVURS-ZEDZUCNESA-L

Description

General description

Calcium folinate, the reduced form of folic acid, finds application in the treatment of methotrexate overdose and in high-dose methotrexate chemotherapy as a chemotherapy protective drug to bring down the latter′s toxicity. When combined with fluorouracil, it is reported to be effective in the management of bowel cancer wherein it acts by inhibiting thymidylate synthase and augmenting the effect of fluorouracil.

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia.For further information and support please go to the website of the issuing Pharmacopoeia.

Application

Calcium folinate for system suitability may be used as an EP reference standard for the determination of the analyte in pharmaceutical formulations by liquid chromatography.

Calcium folinate offsets the effects of folic acid antagonists that act by binding dihydrofolate reductase and blocking the conversion of folic acid to tetrahydrofolate. In medicine, calcium folinate is used after treatment with methotrexate to reduce the toxicity of the methotrexate. Calcium folinate is also used to enhance the cytotoxic effect of 5-fluorouracil in the treatment of cancer.

Packaging

The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

Other Notes

Sales restrictions may apply.

Safety Information

• pictograms: GHS08,GHS07
• signalword: Danger
• hcodes: H315,H317,H319,H334,H335
• pcodes: P261 - P264 - P280 - P304 + P340 + P312 - P342 + P311
• Hazard Classifications: Eye Irrit. 2 - Resp. Sens. 1 - Skin Irrit. 2 - Skin Sens. 1 - STOT SE 3
• target_organs: Respiratory system
• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable