master formula record benzoyl peroxide gel
1.0. PRODUCT INFORMATION :
|Product (Brand) Name||Benzoyl peroxide gel 2.5% w/w|
|Generic Name||Benzoyl peroxide gel 2.5% w/w|
|Benzoyl peroxide||2.5 % w/w|
|Primary Pack Description||Packed in Lami tube|
|Product Description||A Gel filled in lami tube.|
|Storage Condition||Store in a cool, dry & dark place .|
2.0. TABLE OF CONTENT :
|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 :
|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|
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.
(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 % .