Primaquine Phosphate
;)
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].
»Primaquine Phosphate contains not less than 98.0percent and not more than 102.0percent of C15H21N3O·2H3PO4,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed,light-resistant containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
The residue obtained by ignition responds to the test for pyrophosphate as described under Phosphate á191ñ.
Loss on drying á731ñ—
Dry it at 105
for 2hours:it loses not more than 1.0%of its weight.
for 2hours:it loses not more than 1.0%of its weight.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Dissolve about 700mg of Primaquine Phosphate,accurately weighed,in about 75mLof water in a beaker,add 10mLof hydrochloric acid,and proceed as directed under Nitrite Titration á451ñ,beginning with “cool to about 15.”Each mLof 0.1Msodium nitrite is equivalent to 45.53mg of C15H21N3O·2H3PO4.
.”Each mLof 0.1Msodium nitrite is equivalent to 45.53mg of C15H21N3O·2H3PO4.
Auxiliary Information—
Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1619
Phone Number:1-301-816-8394