master formula record sucralfate oral suspension

master formula record sucralfate oral suspension Batch Size: 2000 liters

Product Code
Product (Brand) Name	Sucralfate Oral suspension.
Generic Name	Sucralfate Oral suspension.
Label Claim	Each 5 ml contains
	Sucralfate	1000 mg
	Excipients	q. s.
	Color	Tartrazine
Primary Pack Description	Filled in amber color pet bottles.
Filled Volume	100 ml, 200 ml
Product Description	Light Yellow color oral 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
4.0	BATCH MANUFACTURING PROCESS
5.0	YIELD AND ACCOUNTABILITY
6.0	PRECAUTIONS

3.0. BILL OF RAW MATERIAL :

Sr. No.	Ingredients	Qty in (Kg )	Overages (%)	Qty/batch (Kg)
1.0	Sucralfate*	400.000	–	400.000
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	7.000	–	7.000
6.0	Areosil	9.000	–	9.000
7.0	Sorbitol	600.000	–	600.000
8.0	Sodium Citrate	8.000	–	8.000
9.0	Aspartame	2.000	–	2.000
10.0	Bronopol	0.400	–	0.400
11.0	Tween 80	1.500	–	1.500
12.0	Disodium Edetate	0.400	–	0.400
13.0	Sodium Saccharin	2.000	–	2.000
14.0	Flavour Mango	4.000 Ltr.	–	4.000 Ltr.
14.0	Color Tartrazine	0.010	–	0.010
15.0	Purified Water	q.s.	–	q.s.

NOTE-All Raw Material (Powder form)Should be dissolved in purified water/ Suitable solvents before addition in vessel.

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

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

CALCULATIONS:

(A) For Sucralfate

A.R. No. of Sucralfate

Potency of Sucralfate

LOD of Sucralfate

Required Quantity of Sucralfate = 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 –

4.1.1 Take the approx. 200.000 liter of purified water in manufacturing tank & heat it up to 70 ºC then

add 2.000 Kg Methyl paraben sodium , 0.400 Kg Propyl paraben sodium, 8.000 Kg

Sodium citrate, 0.400 Kg Disodium edetate, 0.400 Kg Bronopol , 2.000 Kg Sodium Saccharin, 2.000 Kg

Aspartame and 2.000 Kg Sodium Benzoate & mix for 30 min.
4.1.2 Add 9.000 Kg Areosil direct to manufacturing vessel and mix for 20 min.
4.1.3 Add 7.000 Kg Xanthan Gum direct to manufacturing vessel and mix for 20 min.
4.1.4 Cool the above solution below 45º C.
4.1.5 Take 600.000 Kg Sorbitol in Storage vessel & add 400.000 Kg Sucralfate mix for 30 min and then

add to manufacturing vessel and mix for 20 min.
4.1.6 Add the 1.500 Kg Tween-80 direct to manufacturing vessel under & mix for 20 min.
4.1.7 Take approx. 10.000 Ltr. Purified water in vessel & dissolve the 0.010 Kg color Tartrazine and add

to manufacturing vessel and mix for 20 min.
4.1.8 Take 4.000 Lit. Flavour Mango in vessel& transfer to manufacturing vessel and mix for 10 min.
4.2 pH ADJUSTMENT-
4.2.1 After completion of activity, Check the pH of bulk between 5.0 to 8.0.
4.3 VOLUME MAKEUP-
4.3.1 Make up the volume up to 2000 liters and mix for 30 min.
4.4 RECIRCULATION & SAMPLING-
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-
4.5.1 Final transfer the bulk to storage vessel through homogenizer.

5.0. YIELD AND ACCOUNTABILITY :

5.1 After completion of process, calculate the % yield. (Limits- 99 – 100 % ).

6.0. PRECUATION :

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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