master formula record Itraconazole Solution Veterinary

master formula record Itraconazole Solution Veterinary Batch Size: 2000 liters

Product Code
Product (Brand) Name	Itraconazole Solution (Veterinary)
Generic Name	Itraconazole Solution (Veterinary)
Label Claim	Each ml contains
	Itraconazole	20 mg
	Excipients	q. s.
	Colour	As per approved colour
Product Description	Almost Yellow color oral solution filled in amber color pet bottles.
Storage Condition	Store in 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
6.0	PRECAUTION

3.0 BILL OF RAW MATERIAL :

Sr. No.	Ingredients	Qty in (Kg)	Overages (%)	Qty/batch (Kg)
1.0	Itraconazole*	40.000	–	40.000
2.0	Sodium Benzoate	2.500	–	2.500
3.0	Xanthan Gum	4.200	–	4.200
4.0	Areosil	2.000	–	2.000
5.0	Propylene Glycol	150.000	–	150.000
6.0	Bronopol	0.500	–	0.500
7.0	Citric Acid	3.000	–	3.000
8.0	Tween 80	1.000	–	1.000

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

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

CALCULATIONS:

(A) For Itraconazole

A.R. No. of Itraconazole

Potency of Itraconazole

LOD of Itraconazole

Required Quantity of Itraconazole (A ) = – Strength/ml x Batch Size (in Liters) x 100 x 100 Kg

— — Potency x (100-LOD) x 1000

4.0 BATCH MANUFACTURING PROCESS :

4.1 BULK MANUFACTURING PROCESS-
4.1.1 Take the Line clearance from IPQA.
4.1.2 Take the approx. 500.000 liter of purified water in manufacturing tank & heat it up to 70º C

then add 0.500 Kg Bronopol , 2.500 Kg Sodium Benzoate & 3.000 kg Citric acid & mix for 30 min.
4.1.3 After dissolution , add 4.200 Kg Xanthan gum to manufacturing vessel & mix for 20 min.
4.1.4 After that add 2.000 Kg Areosil to manufacturing vessel & mix for 20 min .
4.1.5 Take 150.000 Kg Propylene glycol in vessel to dissolve the 40.000 *Kg Itraconazole

and add to manufacturing vessel & mix for 20 min .
4.2 pH ADJUSTMENT-
4.2.1 After completion of activity , Check the pH of bulk between 4.0 to 6.0 .
4.3 VOLUME MAKEUP-
4.3.1 Makeup the volume up to 2000 liters with Purified Water & mix for 30 min.
4.4 RECIRCULATION-
4.4.1 Recirculate the bulk from top to bottom through Homogenizer for 60 min.
4.4.2 Intimate to IPQA to collect the bulk sample .
4.5 FILTRATION-
4.5.1After getting QC release, filter the final bulk to storage vessel through Homogenizer .

5.0 YIELD AND ACCOUNTABILITY :
5.1 After completion of filtration of bulk , calculate the % yield is between 99 – 100 % .
6.0 PRECAUTION :
6.1 Always wear nose mask & hand gloves before starting the manufacturing process.
6.2 Ensure the Environmental conditions is within limits-
6.2.1. Temperature – NMT 27 ºC

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