master formula record furazolidone oral suspension

master formula record furazolidone oral suspension Batch Size: 2000 liter

1.0. PRODUCT INFORMATION :

Product Code
Product (Brand) Name	Furazolidone Oral Suspension
Generic Name	Furazolidone Oral Suspension
Label Claim	Each 5 ml contain
	Furazolidone	25 mg
	Excipients	q. s.
	Color	Sunset yellow
Primary Pack Description	Pet / round bottles.
Product Description	Albendazole 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	–	Furazolidone	10.000 Kg	–	10.000 Kg
2.0	–	Sucrose	600.000 Kg	–	600.000 Kg
3.0	–	Xanthan Gum	8.000 Kg	–	8.000 Kg
4.0	–	Areosil	7.000 Kg	–	7.000 Kg
5.0	–	Methyl Paraben Sodium	2.000 Kg	–	2.000 Kg
6.0	–	Propyl Paraben Sodium	0.400 Kg	–	0.400 Kg
7.0	–	Disodium Edetate	0.500 Kg	–	0.500 Kg
8.0	–	Sodium Saccharin	2.000 Kg	–	2.000 Kg
9.0	–	Citric Acid	2.000 Kg	–	2.000 Kg
10.0	–	Tween 80	2.000 Kg	–	2.000 Kg
11.0	–	Aspartame	2.000 Kg	–	2.000 Kg
12.0	–	Sodium Benzoate	2.000 Kg	–	2.000 Kg
13.0	–	Bronopol	0.400 Kg.	–	0.400 Kg.
14.0	–	Color Sunset Yellow	0.010 Kg	–	0.010 Kg
15.0	–	Flavor Sweet Orange	4.000 Lit.	–	4.000 Lit.
16.0	–	Purified Water	q.s.	–	q.s.

Note : The Required quantity of API is taken as per calculation by using the below mentioned formula.

In above table the quantity of Furazolidone is taken as such basis.

CALCULATIONS:

For Furazolidone

A.R. No. of Furazolidone : __________________

Potency of Furazolidone : __________________

LOD of Furazolidone : __________________

Required Quantity of Furazolidone = 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 400 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 .
4.1.2 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 sufficient quantity of Purified water to dissolve the 2.000 Kg Citric acid and add to

manufacturing vessel under continuous stirring.
4.2.2 Add 8.000 Kg Propylene Glycol 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 0.400 Kg Bronopol and add to

manufacturing vessel under continuous stirring.
4.2.6 Take the sufficient quantity of Purified water to dissolve the 2.000 kg Aspartame 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 Benzoate and

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

add to manufacturing vessel under continuous stirring.
4.2.9 Add 8.000 Kg Xanthan Gum to manufacturing vessel under continuous stirring.
4.2.10 Add 7.000 Kg Areosil direct to manufacturing vessel under continuous stirring.(20 min.).
4.2.11 Take the sufficient quantity of Purified water in vessel & dissolve 10.000 Kg Furazolidone and

add to manufacturing vessel under continuous stirring.
4.2.12 Add the 2.500 Kg Tween-80 direct to manufacturing vessel under continuous stirring.
4.2.13 Take the sufficient quantity of Purified water to dissolve the 0.010 Kg color Sunset Yellow FCF and

add to manufacturing vessel under continuous stirring.
4.2.14 Add 4.000 Lit. Flavour Sweet Orange direct to manufacturing vessel under continuous stirring.
4.3 VOLUME MAKEUP-
4.3.1 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 between 4.5 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 Final transfer the bulk to storage vessel through homogenizer with 60# s.s. sieve.

5.0. YIELD AND ACCOUNTABILITY :

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

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