master formula record ofloxacin oral suspension

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master formula record ofloxacin oral suspension 50 mg/ 5 ml

master formula record ofloxacin oral suspension 50 mg/ 5 ml batch size: 2000 liter

Product Code
Product (Brand) Name	Ofloxacin Oral Suspension 50 mg/ 5 ml
Generic Name	Ofloxacin Oral Suspension 50 mg/ 5 ml
Label Claim	Each 5 ml contain
	Ofloxacin	50 mg
	Excipients	q. s.
	Color	Sunset yellow
Primary Pack Description	Pet / round bottles.
Product Description	Ofloxacin oral Suspension.
Storage Condition	Store in cool, dry & dark place.

2.0. TABLE OF CONTENT :

Sr. No.	Contents
1.0.	PRODUCT INFORMATION
2.0	TABLE OF CONTENT
3.0	BILL OF RAW MATERIAL & CALCULATION
4.0	BATCH MANUFACTURING PROCESS
5.0	YIELD AND ACCOUNTABILITY

3.0. BILL OF RAW MATERIAL :

Sr. No.	RM Code	Ingredients	Qty in (Kg )	Overages (%)	Qty/batch (Kg)
1.0	–	Ofloxacin	20.000 Kg	–	20.000 Kg
2.0	–	Sodium Benzoate	2.000 Kg	–	2.000 Kg
3.0	–	Methyl Paraben Sodium	2.000 Kg	–	2.000 Kg
4.0	–	Propyl Paraben Sodium	0.400 Kg	–	0.400 Kg
5.0	–	Xanthan Gum	8.500 Kg	–	8.500 Kg
6.0	–	Areosil	6.350 Kg	–	6.350 Kg
7.0	–	Sucrose	600.000Kg	–	600.000Kg
8.0	–	Kyron T – 114	30.000 Kg	–	30.000 Kg
9.0	–	Aspartame	2.000 Kg	–	2.000 Kg
10.0	–	Bronopol	0.600 Kg	–	0.600 Kg
11.0	–	Citric Acid	2.000 Kg	–	2.000 Kg
12.0	–	Tween 80	2.000Kg	–	2.000Kg
13.0	–	Disodium Edetate	0.500 Kg	–	0.500 Kg
14.0	–	Sodium Saccharin	2.000 Kg	–	2.000 Kg
13.0	–	Flavour Sweet orange	4.000 lit.	–	4.000 lit.
14.0	–	Color Sunset yellow	0.010 Kg	–	0.010 Kg
15.0	–	Purified Water	q.s.	–	q.s.

CALCULATIONS:

(A) For Ofloxacin

A.R. No. of Ofloxacin : __________________

Potency of Ofloxacin : __________________

LOD of Ofloxacin : __________________

Required Quantity of Ofloxacin = Strength/ml x Batch Size (in Liters) x 100 x 100

—- — — —- —- Potency x (100-LOD) x 1000

4.0. BATCH MANUFACTURING PROCESS :

4.1 SUGAR SYRUP PREPARATION-
4.1.1 Take the Line clearance from IPQA.
4.1.2 Take the 300 liter of purified water in Sugar Syrup manufacturing vessel & heat it up to 80 ℃ – 85 ℃

then add 600 Kg sucrose through vacuum transfer system in Sugar Syrup manufacturing vessel .All the

activity under continuous stirring till the sugar syrup base preparation .
4.1.3 After completion of sugar syrup base preparation , cool the solution below 40 ℃ then transfer the solution

to manufacturing vessel through pre-filter (containing 100 # S.S. Sieve ).
4.2 BULK MANUFACTURING PROCESS-
4.2.1 Take the Line clearance from IPQA.
4.2.2 Take the sufficient quantity of Purified water to dissolve the 2.000 Kg Citric acid and add to manufacturing

vessel under continuous stirring.
4.2.3 Take the sufficient quantity of Purified water to dissolve the 2.000 Kg Methyl paraben sodium and add

to manufacturing vessel under continuous stirring.
4.2.4 Take the sufficient quantity of Purified water to dissolve the 0.400 Kg Propyl paraben sodium and add to

manufacturing vessel under continuous stirring.
4.2.5 Take the sufficient quantity of Purified water to dissolve the 2.000 Kg Sodium Benzoate and add to

manufacturing vessel under continuous stirring .
4.2.6 Take the sufficient quantity of Purified water to dissolve the 0.500 Kg Disodium Edetate and

add to manufacturing vessel under continuous stirring .
4.2.7 Take the sufficient quantity of Purified water to dissolve the 2.000 Kg Sodium Saccharin and

add to manufacturing vessel under continuous stirring .
4.2.8 Take the sufficient quantity of Purified water to dissolve the 0.600 Kg Bronopol and add to manufacturing

vessel under continuous stirring .
4.2.9 Take the sufficient quantity of Purified water to dissolve the 2.000 Kg Aspartame and add to manufacturing

vessel under continuous stirring .
4.2.10 Take the sufficient quantity of Purified water to dissolve the 8.500 Kg Xanthan Gum and add to manufacturing

vessel under continuous stirring .
4.2.11 Take the sufficient quantity of Purified water to dissolve the 6.350Kg Areosil and add to manufacturing

vessel under continuous stirring .
4.2.12 Take sufficient quantity of purified water in vessel & add 30.000 Kg Kyron T -114 mix it for 20 min. the

add 20.000 Kg Ofloxacin & mix it for 4 Hours then transfer it manufacturing tank under continuous stirring.
4.2.13 Take sufficient quantity of purified water to dissolve 0.010 Kg color Sunset yellow and add it to manufacturing

vessel in under continuous.
4.2.14 Take 4.000 lit. Flavour Sweet orange & add it to manufacturing vessel in under continuous vessel .
4.3 VOLUME MAKEUP-
5.3.1 Makeup the volume up to 2000 litre with Purified Water.
4.4 pH ADJUSTMENT-
4.4.1 After completion of activity , Adjust the pH of bulk with citric acid between 4.0 to 5.5
4.5 RECIRCULATION-
4.5.1 Recirculate the bulk from top to bottom through Homogenizer for 60 min.
4.5.2 Intimate to IPQA to collect the bulk sample .
4.6 FILTRATION-
4.6.1 Filter the final bulk to storage vessel through Homogenizer .

5.0. YIELD AND ACCOUNTABILITY :

After completion of filtration of bulk , calculate the % yield is between 98 – 100 % .

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