MFR of hydroxyzine hydrochloride oral solution

1.0. PRODUCT INFORMATION :

master formula record hydroxyzine hydrochloride oral solution batch size: 2000 liter

Product Code
Product (Brand) Name	Hydroxyzine Hydrochloride Oral Solution
Generic Name	Hydroxyzine Hydrochloride Oral Solution
Label Claim	Each ml contain
	Hydroxyzine HCL	6 mg
	Color	Sunset yellow
	Excipients	q.s.
Primary Pack Description	Pet /round bottle
Storage Condition	Store in cool, dry & dark place .

2.0. TABLE OF CONTENT :

Sr. No.	Contents
1	PRODUCT INFORMATION
2	TABLE OF CONTENT
3	BILL OF RAW MATERIAL & CALCULATION
4	BATCH MANUFACTURING PROCESS
5	YIELD AND ACCOUNTABILITY

3.0. BILL OF RAW MATERIAL :

Sr. No.	RM Code	Ingredients	Qty in (Kg)	Overages (%)	Qty/batch (Kg)
1.0	–	Hydroxyzine Hydrochloride	12.000 Kg	–	12.000 Kg
2.0	–	Sucrose	600.000 Kg	–	600.000 Kg
3.0	–	Sodium Benzoate	2.000 Kg	–	2.000 Kg
4.0	–	Methyl Paraben Sodium	2.000 Kg	–	2.000 Kg
5.0	–	Propyl Paraben Sodium	0.400 Kg	–	0.400 Kg
6.0	–	Citric acid	1.500 Kg	–	1.500 Kg
7.0	–	Propylene Glycol	20.000 Kg	–	20.000 Kg
8.0	–	Aspartame	2.000 Kg	–	2.000 Kg
9.0	–	Sodium Saccharin	2.000 Kg	–	2.000 Kg
10.0	–	Xanthan gum (transparent)	2.000 Kg	–	2.000 Kg
11.0	–	Bronopol	0.400 Kg	–	0.400 Kg
12.0	–	Flavour Sweet orange	4.000 Lit.	–	4.000 Lit.
13.0	–	Color Sunset yellow	0.010 Kg	–	0.010 Kg
14.0	–	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 Hydroxyzine Hydrochloride is taken as such basis.

CALCULATIONS:

(A) For Hydroxyzine Hydrochloride

A.R. No. of Hydroxyzine Hydrochloride : __________________

Potency of Hydroxyzine Hydrochloride : __________________

LOD of Hydroxyzine Hydrochloride : __________________

Required Quantity of Hydroxyzine Hydrochloride = Strength/ml x Batch Size (in Liters) x 100 x 100

— — –Potency x (100-LOD) x 1000

4.0. BATCH MANUFACTURING PROCESS :
4.1 SUGAR SYRUP PREPARATION-
4.1.1 Take the Line clearance from IPQA.
4.1.2 Take the 300 liter of purified water in Sugar Syrup manufacturing vessel & heat it up to 80 ℃ – 85 ℃

then add 600 Kg sucrose through vacuum transfer system in Sugar Syrup manufacturing vessel.

All the activity under continuous stirring till the sugar syrup base preparation .
4.1.3 After completion of sugar syrup base preparation , cool the solution below 40 ℃ then transfer the

solution to manufacturing vessel through pre-filter (containing 100 # S.S. Sieve ).
4.2 BULK MANUFACTURING PROCESS-
4.2.1 Take the Line clearance from IPQA.
4.2.2 Take the sufficient quantity of Purified water to dissolve the 1.500 Kg Citric acid and add to

manufacturing vessel under continuous stirring.
4.2.3 Take the sufficient quantity of Purified water to dissolve the 2.000 Kg Methyl paraben sodium and

add to manufacturing vessel under continuous stirring.
4.2.4 Take the sufficient quantity of Purified water to dissolve the 0.400 Kg Propyl paraben sodium and

add to manufacturing vessel under continuous stirring.
4.2.5 Take the sufficient quantity of Purified water to dissolve the 2.000 Kg Sodium Benzoate and add

to manufacturing vessel under continuous stirring .
4.2.6 Take the sufficient quantity of Purified water to dissolve the 2.000 Kg Xanthan gum & add to manufacturing

vessel under continuous stirring .
4.2.7 Take the sufficient quantity of Purified water to dissolve the 0.400 Kg Bronopol and add

to manufacturing vessel under continuous stirring .
4.2.8 Take the sufficient quantity of Purified water to dissolve the 2.000 Kg Aspartame and

add to manufacturing vessel under continuous stirring .
4.2.9 Take the sufficient quantity of Purified water to dissolve the 2.000 Kg Sodium Saccharin and

add to manufacturing vessel under continuous stirring .
4.2.10 Take Sufficient quantity of purified water in vessel & dissolve 12.100 Kg Hydroxyzine Hcl , after this

add 20.000 Kg Propylene glycol under continuous stirring (20 min.), after that transfer it manufacturing vessel .
4.2.11 Take the sufficient quantity of purified water & dissolve 0.010 Kg color Sunset Yellow and

add it to manufacturing vessel in under continuous vessel .
4.2.12 Take 4.000 lit. flavour Sweet Orange & add it to manufacturing vessel in under continuous vessel .
4.3 VOLUME MAKEUP-
4.3.1 Makeup the volume up to 2000 litre with Purified Water.
4.4 pH ADJUSTMENT-
4.4.1 After completion of activity , Adjust the pH of bulk between 2.7 to 3.0
4.4.2 Intimate to IPQA to collect the bulk sample .
4.5 FILTRATION-
4.5.1 Filter the final bulk to storage vessel through filter press(5 micron) .

5.0. YIELD AND ACCOUNTABILITY :

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

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