master formula record cetirizine syrup

master formula record cetirizine hcl syrup 5mg/5ml standard batch size: 2000 liter

Generic Name	Cetirizine Syrup 5mg/5ml
Label Claim	Each 5 ml contain
	Cetirizine HCL IP	5 mg
	Excipients	q. s.
	Color	As per Approved color

Primary Pack Description	Pet bottle 30 ml
Product Description	A clear / transparent syrup Filled in pet bottles.
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
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	–	Cetirizine Hydrochloride	2.000 Kg	–	2.000 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	0.500 Kg	–	0.500 Kg
6.0	–	Citric acid	2.150 Kg	–	2.150 Kg
7.0	–	Propylene Glycol	20.000 Kg	–	20.000 Kg
8.0	–	Xanthan gum (transparent)	2.000 Kg	–	2.000 Kg
9.0	–	Flavour Raspberry	2.000 Lit.	–	2.000 Lit.
10.0	–	Flavour Honey	2.000 Lit.	–	2.000 Lit.
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 Cetirizine Hydrochloride is taken as such basis.

CALCULATIONS:

(A) For Cetirizine

A.R. No. of Cetirizine : __________________

Potency of Cetirizine : __________________

LOD of Cetirizine : __________________

Required Quantity of Cetirizine (A ) = 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 2.000 Kg Citric acid & 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 0.500 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 and add to manufacturing

vessel under continuous stirring .
4.2.7 Take 20 liter purified water in vessel and dissolve 2.000 Kg cetirizine HCL , after this add 20.000 Kg

Propylene glycol under continuous stirring (20 min.), after that transfer it manufacturing vessel .
4.2.8 Take 2.000 lit. flavour Raspberry and add it to manufacturing vessel in under continuous vessel .
4.2.9 Take 2.000 lit. flavour Honey and 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 with citric acid between 4.5 to 5.5
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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