Table I.

Content Uniformity of Split Tablets of Levothyroxine Sodium Marketed Products

Tablet	L-1			L-2			L-3			L-4			L-5
	Whole	Hand	Splitter	Whole	Hand	Splitter	Whole	Hand	Splitter	Whole	Hand	Splitter	Whole	Hand	Splitter
1	103.2	110.0	111.9	106.5	100.4	101.4	100.0	100.2	111.1	77.5	89.6	91.4	98.1	84.5	88.2
2	102.7	97.5	89.9	101.1	102.4	84.2	97.3	101.8	80.2	79.8	83.1	78.4	103.6	118.9	99.5
3	102.7	95.8	111.5	101.7	105.2	98.9	97.8	92.8	109.1	81.5	90.7	82.5	98.7	104.1	93.3
4	102.6	118.4	90.9	98.3	97.4	85.7	97.3	110.2	90.8	79.3	80.2	81.9	101.2	88.9	101.9
5	102.4	115.9	118.0	100.0	99.6	102.0	99.2	96.2	110.1	77.9	82.1	81.2	102.0	99.0	100.8
6	100.6	91.0	92.7	97.4	100.3	86.5	99.2	104.0	82.2	81.5	92.9	87.2	102.7	100.3	92.5
7	104.0	97.3	114.3	99.2	95.7	93.3	99.6	105.2	106.5	81.7	–	88.0	101.6	93.0	104.3
8	106.2	110.1	95.1	99.1	112.0	93.7	100.5	95.9	95.5	78.4	83.5	80.5	99.8	110.3	96.8
9	103.2	99.4	119.4	100.0	94.8	101.4	99.9	100.2	106.0	83.6	79.3	76.7	102.7	102.3	100.1
10	102.3	108.0	89.9	100.3	98.4	97.9	100.7	101.8	87.2	87.1	88.4	74.4	101.1	92.0	94.5
Mean	103.0	104.3	103.4	100.4	100.6	94.5	99.1	100.8	97.9	80.8	85.5	82.2	101.2	99.3	97.2
Stdev	1.4	9.3	12.6	2.5	5.0	6.9	1.3	5.0	12.1	2.9	4.7	5.3	1.8	10.3	5.0
% CV	1.4	8.9	12.2	2.5	5.0	7.3	1.3	5.0	12.4	3.6	5.4	6.5	1.8	10.4	5.2

The assay values presented as italic bold red fonts represent the failure to meet specification of 90.0% to 110.0% of assay value. All the whole tablets except L-4 met the specification, however, failures were observed for both hand- and splitter- split portions for all the marketed tablets