Dissolution 711
Medium:
water; 900 mL.
Apparatus 1:
100 rpm.
Time:
30 minutes.
Procedure
Determine the amount of Li
2CO
3 dissolved in filtered portions of the solution under test with a suitable flame photometer, as directed in the
Assay.
Tolerances
Not less than 80% (Q) of the labeled amount of Li2CO3 is dissolved in 30 minutes.
Assay
Standard preparation
Transfer to a 100-mL volumetric flask about 30 mg of
USP Lithium Carbonate RS, accurately weighed. Add about 20 mL of water and 0.5 mL of hydrochloric acid, shake until dissolved, dilute with water to volume, and mix. Pipet 20 mL of the resulting solution into a 1000-mL volumetric flask, add about 800 mL of water and 20 mL of a suitable surfactant solution, appropriately diluted, dilute with water to volume, and mix.
Assay preparation
Empty as completely as possible the contents of not less than 20 Capsules. Weigh accurately a portion of the powder, equivalent to about 600 mg of lithium carbonate, and transfer to a 1000-mL volumetric flask. Add 40 mL of water and 5 mL of hydrochloric acid, shake until the sample is well disintegrated, dilute with water to volume, and mix. Pipet 10 mL of the resulting solution into a 1000-mL volumetric flask, add about 800 mL of water and 20 mL of the surfactant solution, dilute with water to volume, and mix.
Procedure
Employ a suitable flame photometer, and adjust the instrument with the surfactant solution. Aspirate into the photometer the
Standard preparation and the
Assay preparation, and measure the emission at about 671 nm. Calculate the quantity, in mg, of Li
2CO
3 in the portion of Capsules taken by the formula:
100C(A / S),
in which
C is the concentration, in µg per mL, of
USP Lithium Carbonate RS in the
Standard preparation; and
A and
S are the photometer readings of the
Assay preparation and the
Standard preparation, respectively.