Master formula record Quinine Sulphate Suspension

Master formula record Quinine Sulphate Suspension Batch Size: 2000 liters

1.0 PRODUCT INFORMATION :

Product Code
Product (Brand) Name	Quinine Sulphate Suspension
Generic Name	Quinine Sulphate Suspension
Label Claim	Each 5 ml contains
	Quinine Sulphate IP	150 mg
	Excipients	q. s.
	Color	Sunset yellow
Primary Pack Description	Filled in amber color pet bottles.
Product Description	Light orange color suspension filled in amber color pet bottles.
Storage Condition	Store in cool, dry & 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	Quinine Sulphate *	60.000	–	60.000
2.0	Sodium Benzoate	2.000	–	2.000
3.0	Methyl Paraben Sodium	2.000	–	2.000
4.0	Propyl Paraben Sodium	0.400	–	0.400
5.0	Xanthan Gum	8.000	–	8.000
6.0	Areosil	4.000	–	4.000
7.0	Sucrose	300.000	–	300.000
8.0	Sorbitol	150.000	–	150.000
9.0	Bronopol	0.400	–	0.400
10.0	Tween 80	2.000	–	2.000
11.0	Sodium Citrate	1.200	–	1.200
12.0	Glycerin	150.000	–	150.000
13.0	Citric acid	2.000	–	2.000
14.0	Col. Sunset yellow	0.040	–	0.040
15.0	Flv. Sweet orange	4.000 Ltr.	–	4.000 Ltr.
16.0	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 Quinine Sulphate is taken as such basis.

CALCULATIONS:

(A) For Quinine Sulphate

A.R. No. of Quinine Sulphate

Potency of Quinine Sulphate

LOD of Quinine Sulphate

Required Quantity of Quinine Sulphate = 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 approx. 200 liter of purified water in Sugar Syrup manufacturing vessel & heat it up to 80 ºC then

add 300.000 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 ºC 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 approx. 5.000 Ltr. Purified water & dissolve the 2.000 Kg Methyl paraben sodium and add

to manufacturing vessel & mix for 5 min.
4.2.3 Take approx. 5.000 Ltr. Purified water & dissolve the 0.400 Kg Propyl paraben sodium and add to

manufacturing vessel & mix for 5 min.
4.2.4 Take approx. 5.000 Ltr. Purified water & dissolve the 2.000 Kg Sodium Benzoate and add to manufacturing vessel & mix for 5 min.
4.2.5 Take approx. 10.000 Ltr. Purified water & dissolve the 2.000 Kg Citric acid and add to manufacturing vessel & mix for 5 min.
4.2.6 Take approx. 5.000 Ltr. Purified water & dissolve the 0.400 Kg Bronopol and add to manufacturing vessel & mix for 5 min.
4.2.7 Take approx. 10.000 Ltr. Purified water & dissolve the 1.200 Kg Sodium citrate and add to manufacturing vessel & mix for 5 min.
4.2.8 Take 8.000 Kg Xanthan Gum & add to manufacturing vessel and mix for 20 min.
4.2.9 Take 4.000 Kg Areosil & add to manufacturing vessel & mix for 20 min.
4.2.10 Take 150.000 Kg Sorbitol & 150.000 Kg Glycerin in Storage vessel then dissolve 60.000 Kg* Quinine sulphate,

mix it for 20 min. ,then transfer it manufacturing tank& mix for 10 min.
4.2.11 Take approx. 10.000 Ltr. Purified water in vessel & dissolve 0.040 Kg color Sunset yellow & add it to manufacturing

vessel in and mix for 10 min.
4.2.12 Take 4.000 Ltr. Flavour Sweet orange& add it to manufacturing vessel and mix for 10 min.
4.3 pH ADJUSTMENT-
4.3.1 After completion of activity ,Check the pH of bulk between 4.0 to 6.0
4.4 VOLUME MAKEUP-
4.4.1 Makeup the volume up to 2000 liters with Purified Water and mix for 30 min.
4.5 RECIRCULATION & SAMPLING-
4.5.1 Recirculate the bulk from top to bottom through Homogenizer for 60 min.
4.5.2 Intimate to IPQA to collect the bulk sample .
4.6 FILTRATION-
4.6.1 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 98 – 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

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

master formula record ethamsylate 250 mg injection 2 ml

master formula record ofloxacin oral suspension