MFR of Clobetasol Propionate cream

master formula record Clobetasol Propionate cream 0.05%w/w Batch Size: 300 Kg

1.0. PRODUCT INFORMATION :

Product Code
Product (Brand) Name	Clobetasol Propionate cream 0.05%w/w
Generic Name	Clobetasol Propionate cream 0.05%w/w
Label Claim	Composition
	Clobetasol Propionate	0.05 % 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 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 & 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	–	Clobetasol Propionate	0.150 Kg	–	0.150 Kg
2.0	–	White soft paraffin	36.000 Kg	–	36.000 Kg
3.0	–	Light Liquid Paraffin	18.000 Kg	–	18.000 Kg
4.0	–	Propylene Glycol	10.000 Kg	–	10.000 Kg
5.0	–	Cetostearyl Alcohol	24.500 Kg	–	24.500 Kg
6.0	–	Cetomacrogol – 1000	8.250 Kg	–	8.250 Kg
7.0	–	Chlorocresol	0.300 kg	–	0.300 kg
8.0	–	Sodium dihydrogen phosphate	0.100 Kg	–	0.100 Kg
9.0	–	Bronopol	0.075 Kg	–	0.075 Kg
10.0	–	Butylated Hydroxy Toluene	0.060 Kg	–	0.060 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 Clobetasol Propionate is taken as such basis.

CALCULATIONS:

For Clobetasol Propionate

A.R. No. of Clobetasol Propionate : __________________

Potency of Clobetasol Propionate : __________________

LOD of Clobetasol Propionate : __________________

Required Quantity of Clobetasol Propionate = 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 152.565 Kg Purified water in main manufacturing tank & add 0.075 Kg Bronopol and 0.100 Kg

Sodium dihydrogen phosphate & heat it till 70℃ – 75℃ or up to complete dissolution.
4.2 Take 36.000 Kg White soft paraffin, 24.500 Kg Cetosteryl Alcohol ,8.250 Kg Cetomacrogol-1000 , 0.060 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℃ & 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 10.000 Kg propylene glycol in container and heat it then dissolve 0.150 Kg Clobetasol Propionate

and then transfer it to main manufacturing tank .
4.6 Add 0.300 Kg Chlorocresol in main manufacturing tank & mix for 30 min.
4.7 Maintain the pH between 3.0 to 6.0 .

5.0. YIELD AND ACCOUNTABILITY :

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

master formula record cyproheptadine hcl and tricholine citrate syrup

master formula record l-carnitine injection

master formula record piroxicam injection

master formula record ranitidine injection

master formula record tranexamic acid injection

master formula record cetirizine syrup

MFR of sucralfate oral suspension

Master formula record Quinine Sulphate Suspension

MFR of Paracetamol Phenylephrine Hcl Chlorpheniramine Maleate Drops

master formula record paracetamol oral suspension