master formula record benzoyl peroxide gel

1.0. PRODUCT INFORMATION :

Product Code
Product (Brand) Name	Benzoyl peroxide gel 2.5% w/w
Generic Name	Benzoyl peroxide gel 2.5% w/w
Label Claim	Composition
	Benzoyl peroxide	2.5 % w/w
	Excipients	q.s.
Primary Pack Description	Packed in Lami tube
Product Description	A Gel filled in lami tube.
Shelf-life	24 Months
Storage Condition	Store in a 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.	Ingredients	Qty in (Kg)	Overages (%)	Qty/batch (Kg)
1.0	Benzoyl Peroxide	7.500 Kg	–	7.500 Kg
2.0	Acrypol – 940	4.500 Kg	–	4.500 Kg
3.0	Tween- 80	0.450 Kg	–	0.450 Kg
4.0	Propylene Glycol	12.750 Kg	–	12.750 Kg
5.0	Disodium hydrogen phosphate	0.150 Kg	–	0.150 Kg
6.0	Diethylamine	2.400 Kg	–	2.400 Kg
7.0	Methyl Paraben Sodium	0.300 kg	–	0.300 kg
8.0	Propyl Paraben Sodium	0.060 Kg	–	0.060 Kg
9.0	Bronopol	0.060 Kg	–	0.060 Kg
10.0	Sodium Dihydrogen phosphate	0.030 Kg	–	0.030 Kg
11.0	Disodium Edetate	0.300 Kg	–	0.300 Kg
12.0	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 Benzoyl Peroxide is taken as such basis.

CALCULATIONS:

(A) For Benzoyl Peroxide

A.R. No. of Benzoyl Peroxide : __________________

Potency of Benzoyl Peroxide : __________________

LOD of Benzoyl Peroxide : __________________

Required Quantity of Benzoyl Peroxide (A ) = Label claim x Batch Size (in Kg) x 100 x 100

— Potency x (100-LOD) x 100

4.0. BATCH MANUFACTURING PROCESS :

5.1 Take 271.500 Kg Purified water in main manufacturing tank & add 0.300 Kg di sodium edetate & 0.060 Kg Bronopol, 0.300 Kg Methyl paraben sodium, 0.060 Kg Propyl paraben sodium , 0.150 Kg Disodium hydrogen phosphate , 0.030 Kg Sodium dihydrogen phosphate and 4.500 Kg Acrypol – 940 , & heat it till 70℃ – 75℃ or up to preparation of gel & then cool it below 40℃.
5.2 Take 12.750 Kg propylene glycol in container and heat it then dissolve 7.500 Kg Benzyl Peroxide & transfer it to main manufacturing tank under constant stirring.
5.3 Add 0.450 Kg Tween – 80 to main manufacturing tank under constant stirring.
5.4 Add 2.400 Kg Diethylamine to main manufacturing tank under constant stirring.
5.5 Mix the gel for 30 min.
5.6 Maintain the pH between 5.5 – 7.5 .

5.0. YIELD AND ACCOUNTABILITY :

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

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