master formula record Povidone iodine ointment 5%

master formula record Povidone iodine ointment 5%w/w Batch Size: 300 kg.

1.0 PRODUCT INFORMATION :

Product Code
Product (Brand) Name	Povidone iodine ointment 5%w/w .
Generic Name	Povidone iodine ointment 5%w/w .
Label Claim	Composition
	Povidone Iodine (available iodine 0.5% w/w)	5%
	Excipients	q.s.
Primary Pack Description	Lami tube 20 gm
Product Description	A Brownish ointment filled in lami tube.
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.	RM Code	Ingredients	Qty in (Kg)	Overages (%)	Qty/batch (Kg)
1.0	–	Povidone – Iodine (available iodine 0.5%w/w)	15.000 Kg	–	15.000 Kg
2.0	–	Poly Ethylene Glycol-400	201.000 Kg	–	201.000 Kg
3.0	–	Poly Ethylene Glycol -4000	83.800 Kg	–	83.800 Kg
4.0	–	Potassium Iodide	0.060 Kg	–	0.060 Kg
5.0	–	Purified Water	0.150 Kg	–	0.150 Kg

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

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

CALCULATIONS:

For Povidone Iodine IP

A.R. No. of Povidone Iodine IP : __________________

Potency of Povidone Iodine IP : __________________

LOD of Povidone Iodine IP : __________________

Required Quantity of Povidone Iodine = Label claim x Batch Size (in Kg) x 100 x 100

Potency x (100-LOD) x 100

4.0. BATCH MANUFACTURING PROCESS :
4.1 Take the half quantity( 100.500 Kg ) of Poly ethylene glycol – 400 & 83.800 Kg

of Poly ethylene glycol-4000 in Main Manufacturing vessel & heat it till 80℃ – 85℃ or up

to complete dissolution . then cool it below 45℃ .
4.2 Take 100.500 Kg Poly ethylene glycol- 400 & 15.000 Kg Povidone Iodide in wax melting vessel and

prepare a slurry under continuous stirring approx. 4 hour ( in dark area ).
4.3 After that transfer the slurry in to Main manufacturing vessel at approx. temperature at 40-℃ to 45 ℃ .
4.4 Take 0.150 Kg purified water in vessel & Dissolve 0.060 Kg potassium iodide then transfer it
to Main manufacturing vessel .
4.5 Mix the final bulk for 30 min.
4.6 Check the pH of final bulk ( pH limit- 1.5 to 6.5 ) .

5.0. YIELD AND ACCOUNTABILITY :

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

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