master formula record Levocetirizine Hcl and Montelukast sodium Syrup

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2 years ago

master formula record Levocetirizine Hcl and Montelukast sodium Syrup

Standard Batch Size: 2000 liters

PRODUCT INFORMATION :

Product Code
Product (Brand) Name	Levocetirizine Hcl and Montelukast sodium Syrup
Generic Name	Levocetirizine Hcl and Montelukast sodium Syrup
Label Claim	Each 5ml contain
	Levocetirizine Hydrochloride IP	2.5 mg
	Montelukast Sodium IP Eq. to Montelukast	4 mg
	Color	Quinoline yellow
	Excipients	q. s.
Primary Pack Description	Filled in amber color pet bottles.
Fill Volume	30 ml, 60 ml
Product Description	A Lemon yellow color oral syrup filled in amber color pet bottles.
Shelf-life	24 Months
Storage Condition	Store in cool, dry and dark place .

2.0. TABLE OF CONTENT :

Sr. No.	CONTENTS	Page No.
1.0	PRODUCT INFORMATION
2.0	TABLE OF CONTENT
3.0	FLOW-CHART FOR FORMULATION
4.0	BILL OF RAW MATERIAL and CALCULATION
5.0	BATCH MANUFACTURING PROCESS
6.0	YIELD AND ACCOUNTABILITY
7.0	PRECAUTIONS

4.0. BILL OF RAW MATERIAL :

Sr. No.	Ingredients	Qty in (Kg)	Overages (%)	Qty/batch (Kg)
1.0	Montelukast Sodium*	1.680	–	1.680
2.0	Levocetirizine HCL*	1.000	–	1.000
3.0	Acrysol K-150	48.000	–	48.000
4.0	PEG-400	45.000	–	45.000
5.0	Glycerin	800.000	–	800.000
6.0	Aspartame	3.000	–	3.000
7.0	Potassium Hydroxide	0.100	–	0.100
8.0	Methyl paraben sodium	4.000	–	4.000
9.0	Propyl paraben sodium	0.400	–	0.400
10.0	Sodium saccharin	2.000	–	2.000
11.0	Disodium edetate	0.400	–	0.400
12.0	Col. Quinoline yellow	0.020	–	0.020
13.0	Flv. Pineapple	6.000 Ltr.	–	6.000 Ltr.
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 Montelukast Sodium, & Levocetirizine HCL is taken as such basis.

5.0. BATCH MANUFACTURING PROCESS :
5.1 BULK MANUFACTURING PROCESS-
5.1.1 Take 800.000 Kg Glycerin in manufacturing Vessel & add 4.000 Kg Methyl paraben sodium, 0.400 Kg Propyl paraben sodium, 0.400 Kg Disodium edetate, 3.000 Kg Aspartame, 2.000 Kg Sodium Saccharin & mix it for 30 min. for clear solution.
5.1.2 Take 45.000 Kg PEG-400 & 48.000 Kg Acrysol K-150 in vessel & heat it then dissolve 1.680 Kg* Montelukast sodium then transfer to manufacturing tank & mix for 20 min. for clear solution.
5.1.3 Take approx. 30.000 Ltr. Purified water in vessel & add 0.100 Kg Potassium hydroxide then dissolve 1.000 Kg * Levocetirizine Hcl then transfer to manufacturing tank & mix for 10 min. for clear solution.
5.1.4 Take approx. 10.000 Ltr. Purified water in vessel & dissolve 0.020Kg Col. Quinoline yellow then transfer to manufacturing tank & mix for 10 min. for clear solution.
5.1.5 Take 6.000 Ltr. Flv. Pineapple in vessel then transfer to manufacturing tank & mix for 10 min.
5.2 pH ADJUSTMENT-
5.2.1 After completion of activity, Check the pH of bulk between 8.0 to 10.0.
5.3 VOLUME MAKEUP & SAMPLING –
5.3.1 Make up the volume up to 2000 liters & mix for 30 min.
5.3.2 Intimate to IPQA to collect the bulk sample for analysis.
5.4 FILTRATION –
5.4.1 After getting QC release, transfer the bulk to storage vessel through filter press.

6.0. YIELD AND ACCOUNTABILITY :
6.1 After completion of process, calculate the % yield. (Limits- 99 – 100 % ).
7.0. PRECUATION :

7.1 Always wear nose mask & hand gloves before starting the manufacturing process.
7.2 Ensure the Environmental conditions is within limits-
7.2.1. Temperature – NMT 27 ºC

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