master formula record lactulose solution

1.0. PRODUCT INFORMATION

Standard Batch Size: 2000 liters

Product Code
Product (Brand) Name	Lactulose Solution
Generic Name	Lactulose Solution
Label Claim	Each 5 ml contain
	Lactulose Solution	3.35 gm
	In a Palatable Base	q. s.
Primary Pack Description	Filled in amber color Pet / round bottle
Fill Volume	100 ml, 150 ml, 170 ml & 200 ml.
Product Description	A clear / transparent syrup Filled in amber color pet / round bottles.
Shelf-life	24 Months
Storage Condition	Store in cool, dry & dark place .

2.0. TABLE OF CONTENT

Sr. No.	CONTENTS	Page No.
1	PRODUCT INFORMATION
2	TABLE OF CONTENT
3	FLOW-CHART FOR FORMULATION
4	BILL OF RAW MATERIAL
5	BATCH MANUFACTURING PROCESS
6	YIELD AND ACCOUNTABILITY
7	PRECAUTIONS

5.0. BATCH MANUFACTURING PROCESS :
5.1 Transfer the 2697.000 Kg Lactulose solution through transfer pump in manufacturing tank .
5.2 Heat the solution up to 70 ℃ & mix it for 30 min during heating.
5.3 Intimate to IPQA to collect the bulk sample .
5.1 FILTRATION-
5.1.1 Filter the final bulk to storage vessel through filter press(200# nylon cloth) .

6.0. YIELD AND ACCOUNTABILITY :

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

7.0. PRECAUTIONS :

7.1. Always wear nose mask & hand gloves before starting the manufacturing process.
7.2 Ensure the Environmental conditions is within limits

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