master formula record paracetamol oral suspension

master formula record paracetamol oral suspension 250 mg/5ml Batch Size: 2000 liter

1.0 PRODUCT INFORMATION :

Product Code
Generic Name	Paracetamol oral Suspension 250 mg/5ml.
Label Claim	Each 5 ml contain
	Paracetamol	250 mg
	Excipients	q. s.
	Color	Ponceau 4R
Primary Pack Description	60 ml pet / round bottles.
Product Description	Paracetamol 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

NOTE- All Raw Material (Powder form)Should be dissolved in purified water before enter in vessel.

3.0. BILL OF RAW MATERIAL :

Sr. No.	RM Code	Ingredients	Qty in (Kg)	Overages (%)	Qty/batch (Kg)
1.0	–	Paracetamol	100.000 Kg	–	100.000 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	6.350 Kg	–	6.350 Kg
6.0	–	Areosil	8.500 Kg	–	8.500 Kg
7.0	–	Sucrose	250.000Kg	–	250.000Kg
8.0	–	Sorbitol solution 70 %	300.000 Kg	–	300.000 Kg
9.0	–	Propylene Glycol	50.000 Kg	–	50.000 Kg
10.0	–	Aspartame	2.000 Kg	–	2.000 Kg
11.0	–	Bronopol	0.400 Kg	–	0.400 Kg
12.0	–	Disodium Edetate	0.500 Kg	–	0.500 Kg
13.0	–	Citric Acid	3.000 Kg	–	3.000 Kg
14.0	–	Tween 80	2.000 Kg	–	2.000 Kg
15.0	–	Sodium Saccharin	2.000 Kg	–	2.000 Kg
16.0	–	Flavour Raspberry	4.000 Lit.	–	4.000 Lit.
17.0	–	Color Ponceau 4R	0.015 Kg	–	0.015 Kg
18.0	–	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 Paracetamol is taken as such basis.

CALCULATIONS:

(A) For Paracetamol

A.R. No. of Paracetamol : __________________

Potency of Paracetamol : __________________

LOD of Paracetamol : __________________

Required Quantity of Paracetamol = 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 200 liter of purified water in Sugar Syrup manufacturing vessel & heat it up to 80 ℃ – 85 ℃ then

add 250 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 Line clearance from IPQA.
4.2.2 Take the sufficient quantity of Purified water to dissolve the 3.000 Kg Citric acid amd add to manufacturing

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

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

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

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

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

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

vessel under continuous stirring .
4.2.10 Take the 50.000 Kg propylene Glycol in vessel & add 6.000 Kg xanthan Gum to prepare the slurry under

continuous stirring (30 min.) in vessel. Then transfer it manufacturing vessel under continuous stirring .
4.2.11 Take the 300.000 Kg Sorbitol in vessel & add 100.000 Kg Paracetamol to prepare the slurry under continuous

stirring 30 min., Then transfer it manufacturing vessel under continuous stirring.
4.2.12 Add 8.500 Kg Areosil direct to manufacturing vessel under continuous stirring.(20 min.).
4.2.13 Add the 2.000 Kg Tween-80 direct to manufacturing vessel under continuous stirring.
4.2.14 Take the sufficient quantity of Purified water to dissolve the 0.040 Kg color Ponceau 4R and add 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 with citric acid between 4.0 to 6.0
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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master formula record paracetamol oral suspension