LEUCOVORIN CALCIUM

NSC - 3590

SMILES: [Ca+2].Nc1nc(O)c2N(C=O)C(CNc3ccc(cc3)C(=O)N[C@@H](CCC(=O)O)C(=O)O)CNc2n1

Chemical Name:N-[4-[[(2-A mino-5-form y1-1,4,5,6,7,8-hexa-hydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-L-glutamic acid,calcium salt (1:1), (R,S)-

Other Names: Citrovorum Factor, Folinic Acid, Leucosar®, Wellcovorin®, Leucovorin Calcium (USAN)

CAS Registry Number: 1492-18-8

Molecular Formula: C20H25N7O7 • Ca           M.W.: 511.5

How Supplied: For Injection, 50 mg (leucovorin equivalent
present as calcium salt), vial, with sodium chloride, 45 mg. The
product is prepared as a pale-yellow lyophilized powder in 10 mL
flint vials.

For Injection, 500 mg (leucovorin equivalent present as calcium
salt), vial, with sodium chloride, 80 mg. The product is prepared
as a pale-yellow lyophilized powder in 30 mL flint vials.

Solution Preparation: 50 mg/vial: When constituted with 5 mL
of Sterile Water for Injection, USP, each milliliter contains
leucovorin calcium equivalent to leucovorin 10 mg and sodium
chloride 9 mg. The pH of the solution is 6.0 to 8.0.

500 mg/vial : When constituted with 9.7 mL of Sterile Water for
Injection, USP, each milliliter contains leucovorin calcium
equivalent to leucovorin 50 mg and sodium chloride 8 mg. The
pH of the solution is 6.5 to 8.5.

Storage: Store the intact vials at room temperature.

Stability: The intact vials are stable up to the expiration date
when stored at room temperature (22-25 °C). Shelf-life studies on
the 500 mg dosage form are ongoing.

Constitution as directed results in a solution which is chemically
stable for at least 7 days at room temperature.

CAUTION: It is advised that the vials constituted
with Sterile Water for Injection, USP, be discarded
within 8 hours of initial entry.

Route of Administration: Intramuscular, intravenous, oral