master formula record ondansetron oral solution

1.0. PRODUCT INFORMATION :

master formula record ondansetron oral solution Batch Size 2000 liter

Product Code
Product (Brand) Name	Ondansetron Oral Solution
Generic Name	Ondansetron Oral Solution
Label Claim	Each 5 ml contain
	Ondansetron HCL Eq. to Ondansetron	2 mg
	Color	Ponceau 4R
	Excipients	q. s.
Primary Pack Description	Pet bottle
Product Description	A clear / transparent solution 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 & 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	–	Ondansetron Hydrochloride	1.000 Kg	–	1.000 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	0.660 Kg	–	0.660 Kg
6.0	–	Citric acid	4.200 Kg	–	4.200 Kg
7.0	–	Propylene Glycol	5.000 Kg	–	5.000 Kg
8.0	–	Aspartame	3.000 Kg	–	3.000 Kg
9.0	–	Sodium Citrate	1.500 Kg	–	1.500 Kg
10.0	–	Bronopol	0.500 Kg	–	0.500 Kg
11.0	–	Xanthan gum (transparent)	1.000 Kg	–	1.000 Kg
12.0	–	Col. Ponceau 4R	0.025 Kg	–	0.025 Kg
13.0	–	Flavour Raspberry	2.000 Lit.	–	2.000 Lit.
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 Ondansetron Hydrochloride is taken as such basis.

CALCULATIONS:

(A) For Ondansetron Hydrochloride

A.R. No. of Ondansetron Hydrochloride : __________________

Potency of Ondansetron Hydrochloride : __________________

LOD of Ondansetron Hydrochloride : __________________

Required Quantity of Ondansetron Hydrochloride = 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 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 4.200 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 0.660 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 1.000 Kg Xanthan gum and

add to manufacturing vessel under continuous stirring .
4.2.7 Take the sufficient quantity of Purified water to dissolve the 3.000 Kg Aspartame and

add to manufacturing vessel under continuous stirring .
4.2.8 Take the sufficient quantity of Purified water to dissolve the 1.500 Kg Sodium Citrate and

add to manufacturing vessel under continuous stirring .
4.2.9 Take the sufficient quantity of Purified water to dissolve the 0.500 Kg Bronopol and

add to manufacturing vessel under continuous stirring .
4.2.10 Take 5.000 Kg Propylene Glycol in vessel & dissolve 1.000 Kg Ondansetron HCL and

transfer it manufacturing vessel under continuous stirring .
4.2.11 Take the sufficient quantity of Purified water to dissolve the 0.025 Kg Color Ponceau 4R and

add to manufacturing vessel under continuous stirring .
4.2.13 Take 2.000 lit. flavour Raspberry & 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 3.3 – 4.0.
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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