(prim' a kwin fos' fate).
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 NLT 98.0% and NMT 102.0% of C15H21N3O·2H3PO4, calculated on the dried basis.
• A. Infrared Absorption 197K: Meets the requirements
• B. The residue obtained by ignition meets the requirements of the test for Pyrophosphate, as described under Identification TestsGeneral 191, Phosphate.
• C. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Change to read:• Procedure
Mobile phase: Acetonitrile, tetrahydrofuran, trifluoroacetic acid, and water (9: 1: 0.1: 90)
Standard solution: 0.4 mg/mL of USP Primaquine Phosphate RS in Mobile phase. [NoteSonicate with intermittent shaking to dissolve, if necessary. ]
System suitability stock solution: 0.4 mg/mL of USP Primaquine Related Compound A RS in Mobile phase
System suitability solution: Transfer 1.0 mL of the System suitability stock solution to a 10-mL volumetric flask, and dilute with Standard solution to volume.
Sensitivity solution: 0.2 µg/mL of USP Primaquine Phosphate RS from the Standard solution
Sample solution: 0.4 mg/mL in Mobile phase. [NoteSonicate with intermittent shaking to dissolve, if necessary. ]
Detector: UV 265 nm
Column: 4.6-mm × 75-mm; 3-µm packing L7
Flow rate: 1.5 mL/min
Injection size: 10 µL
Run time: Three times the retention time of primaquine
Samples: Standard solution, System suitability solution, and Sensitivity solution
Resolution: NLT 2.5 between primaquine and primaquine related compound A, System suitability solution
Relative standard deviation: NMT 1.0% for primaquine, Standard solution
Signal-to-noise ratio: NLT 10 for the primaquine peak, Sensitivity solution
Samples: Standard solution and Sample solution
Calculate the percentage of primaquine phosphate (C15H21N3O·2H3PO4) in the portion of Primaquine Phosphate taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria: 98.0%102.0% on the dried basisUSP35
Add the following:• Organic Impurities
Mobile phase, Standard solution, System suitability solution, Sensitivity solution, Sample solution, Chromatographic system, and System suitability: Proceed as directed in the Assay.
Sample: Sample solution
Calculate the percentage of each impurity in the portion of Primaquine Phosphate taken:
Result = (rU/rT) × 100
Acceptance criteria: See Table 1.USP35
[NoteDisregard any impurity less than 0.05%. ]
• Loss on Drying 731: Dry a sample at 105 for 2 h: it loses NMT 1.0% of its weight.
• Packaging and Storage: Preserve in well-closed, light-resistant containers.
Change to read:• USP Reference Standards 11
USP Primaquine Related Compound A RSUSP35
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4412Pharmacopeial Forum: Volume No. 37(1)