The material was sieved through a 12# sieve using 30 diameter sifter and divided into two equal lots.

In a 200-liter stainless steel vessel, 90 kg of purified water and polyvinyl pyrrolidone were added under continuous stirring for 20 min to obtain a clear solution. (Divide the solution into two equal lots, lot A and lot B).

Table 1

Results of flow properties after mixing
Batch number	Bulk density (g/ml)		Tapped density (g/ml)					Carr’s index (%)
5000816	0.688		0.796					13.567
5000916	0.655		0.764					14.26
5001016	0.692		0.774					10.59
Results of moisture content determination of Levofloxacin Tablet I.P. 500 mg validation batches
Batch number	Sampling points		Temp (˚C)		Laps time (min)		Moisture content (%w/w) (Limit: 2- 3%W/W)
5000816	Top		101		3.6		2.60
	Middle		103		3.8		2.68
	Bottom		102		3.2		2.71
5000916	Top		102		3.4		2.56
	Middle		101		4		2.78
	Bottom		104		3.1		2.79
5001016	Top		103		4.2		2.31
	Middle		101		3.5		2.77
	Bottom		102		3.9		2.81
Flow properties after blending
Batch number	Bulk density (g/ml)		Tapped density (g/ml)		Carr’s index (%)		Angle of repose (ꜗ ꜗ ⱷ)
5000816	0.660		0.762		13.38		26.71
5000916	0.666		0.775		14.06		27.11
5001016	0.656		0.769		14.69		28.31
Levofloxacin Tablet I.P. 500mg-blend sample Assay
Lubrication time		Sampling points		Batch number
				5000816		5000916			5001016
15 mins		Top(mg)		522.86		521.23			520.36
		Middle(mg)		519.83		520.01			512.65
		Bottom(mg)		519.73		507.25			513.52
17 mins		Top(mg)		520.91		515.32			516.21
		Middle(mg)		523.40		510.24			512.23
		Bottom(mg)		508.05		510.54			509.31
20 mins		Top(mg)		522.43		521.41			518.23
		Middle(mg)		522.54		522.52			522.23
		Bottom(mg)		513.65		521.64			514.24
Dissolution comparison of Levofloxacin Tablet I.P. 500mg
Batch number					Average % drug release
5000816					99.53
5000916					101.185
5001016					102.155

Table 2

Compression at different RPM and hopper level of Batch No- 5000816
RPM	Powder level in hoper	Average weight 784mg- 814mg	Thickness 6.0mm + 0.1 mm		Hardness NLT 4.0Kg/cm2	Friability NMT 1.0%W/W	Disintegration time NMT 10 mins
18 RPM	Full	799	6.0		7	0.22	5
	Half	801	5.9		8	0.25	4.5
	Almost empty	798	6.0		8	0.52	4.3
20 RPM	Full	800	6.0		7	0.78	4
	Half	798	6.1		7	0.45	5
	Almost empty	802	6.1		7	0.34	5.2
22 RPM	Full	797	6.0		8	0.28	5
	Half	801	6.0		7	0.36	5
	Almost empty	803	6.0		7	0.50	4
Compression at different RPM and hopper level of Batch No- 5000916
RPM	Powder level in hoper	Average weight 784mg- 814mg	Thickness 6.0mm + 0.1 mm		Hardness NLT 4.0Kg/cm2	Friability NMT 1.0%W/W	Disintegration time NMT 10 mins
18 RPM	Full	795	6.1		8	0.44	5.4
	Half	800	6.0		8	0.22	4.2
	Almost empty	799	6.0		8	0.85	4
20 RPM	Full	800	5.9		7	0.45	4.5
	Half	797	6.0		8	0.53	5.1
	Almost empty	801	6.1		7	0.63	5
22 RPM	Full	799	6.0		8	0.35	5
	Half	801	6.1		7	0.78	5.2
	Almost empty	802	6.0		7	0.49	5.1
Dissolution of Levofloxacin Tablet I.P. 500mg coated tablet - Batch No- 5001016
RPM	Powder level in hoper	Average weight 784mg- 814mg	Thickness 6.0mm + 0.1 mm		Hardness NLT 4.0Kg/cm2	Friability NMT 1.0%W/W	Disintegration time NMT 10 mins
18 RP M	Full	800	6.0		7	0.54	5.1
	Half	804	6.0		8	0.66	5
	Almost empty	801	5.9		8	0.31	4.4
20 RP M	Full	801	6.0		8	0.64	5
	Half	796	6.0		8	0.84	5.1
	Almost empty	802	6.0		7	0.78	5.4
22 RP M	Full	804	5.9		8	0.46	4.5
	Half	795	6.1		8	0.64	5.1
	Almost empty	800	6.0		7	0.34	5.2
Dissolution comparison of Levofloxacin Tablet I.P. 500mg
Batch number				Average % drug release
5000816				100.513
5000916				102.47
5001016				101.218

Table 3

Sl. No	Parameters	Specification	Observation			Results
			5000816	5000916	5001016
1	Appearance	Light orange colored capsule shaped tablet	Light orange colored capsule shaped tablet	Light orange colored capsule shaped tablet	Light orange colored capsule shaped tablet	Complies
2	Average weight	800mg [(+2%of 800mg)784mg to 816mg]	805	810	812	Complies
3	Hardness	NLT 4.0kg/cm2	7	8	7	Complies
4	Thickness	6.0+0.1mm	6.01	6.0	6.05	Complies
5	Disintegration	NLT 4 min	5.2	4.9	5.20	complies
6	Dissolution	NLT 80%	101.51	102.47	101.218	complies

All sieved raw materials were loaded into a rapid mixer granulator and mixed for 5 min, after which the binding solution was added and mixed for another 10 min to obtain a uniform wet mass.

The tablets were loaded onto a coating pan, and the coating solution was sprayed on warm tablets at a rate of 500 g/ml, keeping both hot air and exhaust. Spraying was continued until the coating solution was exhausted, and the tablets were dried for at least 30 min. After the completion of coating, 20 tablets were taken, and the average weight was noted. The increase in the average weight of core tablets should be between 8 and 10 mg. The tablets were unloaded and stored in double-polyethene lines plastic drums. After coating, several critical parameters were monitored to ensure the tablet quality.

After inspection and finished product testing of the manufactured product, all the materials from the packing area were removed and the inspection labels were stamped on carton boxes with batch no, manufactured date, and expiry date.