master formula record Fluconazole Cream 0.5% w/w

master formula record Fluconazole Cream 0.5% w/w Batch Size: 300 Kg

Product Code
Product (Brand) Name	Fluconazole Cream 0.5% w/w
Generic Name	Fluconazole Cream 0.5% w/w
Label Claim	Composition
	Fluconazole	0.5 % w/w
	Excipients	q.s.
Primary Pack Description	Packed in Lami tube
Product Description	A Off white cream 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	–	Fluconazole	1.500 Kg	–	1.500 Kg
2.0	–	White soft paraffin	36.000 Kg	–	36.000 Kg
3.0	–	Light Liquid Paraffin	19.500 Kg	–	19.500 Kg
4.0	–	Propylene Glycol	21.000 Kg	–	21.000 Kg
5.0	–	Cetostearyl Alcohol	22.500 Kg	–	22.500 Kg
6.0	–	Cetomacrogol – 1000	7.500 Kg	–	7.500 Kg
7.0	–	Methyl Paraben	0.150 kg	–	0.150 kg
8.0	–	Propyl Paraben	0.075Kg	–	0.075Kg
9.0	–	Bronopol	0.060 Kg	–	0.060 Kg
10.0	–	Butylated Hydroxy Toluene	0.060 Kg	–	0.060 Kg
11.0	–	Disodium Edetate	0.075 Kg	–	0.075 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 Fluconazole is taken as such basis.

CALCULATIONS:

For Fluconazole

A.R. No. of Fluconazole : __________________

Potency of Fluconazole : __________________

LOD of Fluconazole : __________________

Required Quantity of Fluconazole = 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 141.580 Kg Purified water in main manufacturing tank & add 0.075 Kg di sodium edetate and

0.060 Kg Bronopol and heat it till 70℃ – 75℃ or up to complete dissolution.
4.2 Take 36.000 Kg White soft paraffin, 22.500 Kg Cetosteryl Alcohol ,7.500 Kg Cetomacrogol-1000 , 0.060 Kg

Butylated hydroxy toluene and 19.500 Kg Light Liquid Paraffin in wax melting vessel and heat it

approx. 80℃ or up to complete dissolution under continuous stirring.
4.3 Take 50.000 Kg Purified water in water tank & heat it approx. 70℃ – 75℃ and add to wax melting tank under constant stirring.
4.4 After complete dissolution of wax materials transfer it to Main manufacturing vessel under continuous stirring .
4.5 Take 5.000 Kg propylene glycol in container and heat it then dissolve 0.150 Kg methyl paraben

and 0.075 Kg propyl paraben then transfer it to main manufacturing tank & then cool it below 40℃.
4.6Take 16.000 Kg propylene glycol in container & heat it & dissolve 1.500 Kg Fluconazole and add it

in main manufacturing tank & mix for 30 min.
4.7 Maintain the pH between 4.0 to 6.0 .

5.0. YIELD AND ACCOUNTABILITY :

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

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