master formula record Halobetasol Propionate with Fusidic acid Cream

MFR of Halobetasol Propionate with Fusidic acid Cream Standard Batch Size: 300 Kg

Product Code
Product (Brand) Name	Halobetasol Propionate with Fusidic acid Cream
Generic Name	Halobetasol Propionate with Fusidic acid Cream
Label Claim	Composition
	Halobetasol Propionate	0.05% w/w
	Fusidic Acid	2 % w/w
	Excipients	q.s.
Primary Pack Description	Packed in lami tube
Product Description	Cream filled in lami tube.
Storage Condition	Store in a cool, dry and 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 AND 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	–	Halobetasol Propionate	0.150 Kg	–	0.150 Kg
2.0	–	Fusidic Acid	6.000 Kg	–	6.000 Kg
3.0	–	Light Liquid Paraffin	18.000 Kg	–	18.000 Kg
4.0	–	Propylene Glycol	24.000 Kg	–	24.000 Kg
5.0	–	Cetostearyl Alcohol	24.750 Kg	–	24.750 Kg
6.0	–	Cetomacrogol – 1000	8.250 Kg	–	8.250 Kg
7.0	–	Butylated Hydroxy toluene	0.150 kg	–	0.150 kg
8.0	–	Sorbic Acid	0.300 Kg	–	0.300 Kg
9.0	–	Disodium hydrogen phosphate	0.450 Kg	–	0.450 Kg
10.0	–	White soft paraffin	36.000 Kg	–	36.000 Kg
11 .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 Halobetasol Propionate and Fusidic Acid is taken as such basis.

CALCULATIONS:

For Halobetasol Propionate IP

A.R. No. of Halobetasol Propionate IP : ___________

Potency of Halobetasol Propionate ne IP : ___________

LOD of Halobetasol Propionate IP : ____________

Required Quantity of Halobetasol Propionate (A ) = Label claim x Batch Size (in Kg) x 100 x 100

— — — Potency x (100-LOD) x 100

For Fusidic Acid IP

A.R. No. of Fusidic Acid IP : _____________

Potency of Fusidic Acid IP : ____________

LOD of Fusidic Acid IP : _____________

Required Quantity of Fusidic Acid (B ) = 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 131.950 Kg Purified water in main manufacturing tank and add 0.450 Kg Disodium hydrogen phosphate

and heat it till 70℃ – 75℃ or up to complete dissolution.
4.2 Take 36.000 Kg White soft paraffin, 24.750 Kg Cetosteryl Alcohol ,8.250 Kg Cetomacrogol-1000 , 0.150 Kg

Butylated hydroxy toluene &18.000 Kg Light Liquid Paraffin in wax melting vessel & 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

then cool it below 40℃.
4.5 Take 3.000 Kg propylene glycol in container and heat it then dissolve 0.300 Kg Sorbic acid and

then transfer it to main manufacturing tank .
4.6 Take 6.000 Kg propylene glycol in container and heat it then dissolve 0.150 Kg Halobetasol propionate

and then transfer it to main manufacturing tank .
4.7 Take15.000 Kg propylene glycol in container and heat it then dissolve 6.000 Kg Fusidic acid and then

transfer it to main manufacturing tank &mix the final bulk for 30 min.
4.7 Maintain the pH between 3.5 to 5.5 .

5.0. YIELD AND ACCOUNTABILITY :

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