master formula record albendazole oral suspension

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3 years ago

master formula record albendazole oral suspension

1.0 PRODUCT INFORMATION :

Product Code
Product (Brand) Name	Albendazole Oral Suspension
Generic Name	Albendazole Oral Suspension
Label Claim	Each 5 ml contain
	Albendazole	200 mg
	Excipients	q. s.
	Color	Erythrosine
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	–	Albendazole	80.000 Kg	–	80.000 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	0.500 Kg	–	0.500 Kg
5.0	–	Xanthan Gum	8.000 Kg	–	8.000 Kg
6.0	–	Areosil	6.000 Kg	–	6.000 Kg
7.0	–	Sucrose	600.000Kg	–	600.000Kg
8.0	–	Propylene Glycol	8.000 Kg	–	8.000 Kg
9.0	–	Aspartame	4.000 Kg	–	4.000 Kg
10.0	–	Bronopol	0.400 Kg	–	0.400 Kg
11.0	–	Citric Acid	4.000 Kg	–	4.000 Kg
12.0	–	Tween 80	2.500Kg	–	2.500 Kg
13.0	–	Flavour Raspberry	4.000 lit.	–	4.000 lit.
14.0	–	Color Erythrosine	0.020 Kg	–	0.020 Kg
15.0	–	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 Albendazole is taken as such basis.

CALCULATIONS:

(A) For Albendazole

A.R. No. of Albendazole : __________________

Potency of Albendazole : __________________

LOD of Albendazole : __________________

Required Quantity of Albendazole = 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 4.000 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 0.500 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 4.000 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 Add 8.000 Kg Xanthan Gum to manufacturing vessel under continuous stirring.
4.2.9 Add 8.000 Kg Areosil direct to manufacturing vessel under continuous stirring.(20 min.).
4.2.10 Take the sufficient quantity of Purified water in vessel & dissolve 80.000 Kg Albendazole and

add to manufacturing vessel under continuous stirring.
4.2.11 Add the 2.500 Kg Tween-80 direct to manufacturing vessel under continuous stirring.
4.2.12 Take the sufficient quantity of Purified water to dissolve the 0.020 Kg color Erythrosine and

add to manufacturing vessel under continuous stirring.
4.2.13 Add 4.000 Lit. Flavour Raspberry 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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