C15H21N3O·2H3PO4 455.34

1,4-Pentanediamine, N4-(6-methoxy-8-quinolinyl)-, (±)-, phosphate (1:2).
(±)-8-[(4-Amino-1-methylbutyl)amino]-6-methoxyquinoline phosphate (1:2) [63-45-6].

Packaging and storage— Preserve in well-closed, light-resistant containers.

USP Reference standards 11— USP Primaquine Phosphate RS.

Identification—

Loss on drying 731— Dry it at 105 for 2 hours: it loses not more than 1.0% of its weight.

Organic volatile impurities, Method I 467: meets the requirements.

Residual solvents 467: meets the requirements.

Assay— Dissolve about 700 mg of Primaquine Phosphate, accurately weighed, in about 75 mL of water in a beaker, add 10 mL of hydrochloric acid, and proceed as directed under Nitrite Titration 451, beginning with “cool to about 15.” Each mL of 0.1 M sodium nitrite is equivalent to 45.53 mg of C15H21N3O·2H3PO4.

Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials

USP29–NF24 Page 1799

Phone Number : 1-301-816-8394