master formula record vitamin D3 drops

master formula record vitamin d3 drops Batch Size: 2000 liters

1.0 PRODUCT INFORMATION :

Product Code
Product (Brand) Name	Vitamin D3 Drops
Generic Name	Vitamin D3 Drops
Label Claim	Each 5ml contains
	Vitamin D3 (Cholecalciferol)	45000 I.U.
	Excipients	q. s.
	Colour	As per approved colour
Primary Pack Description	Filled in amber colour Pet bottle.
Product Description	Light orange colour oral drop filled in amber colour 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	PRECAUTION

3.0. BILL OF RAW MATERIAL :

Sr. No.	Ingredients	Qty in (Kg)	Overages (%)	Qty/batch (Kg)
1.0	Vitamin D3*	0.900	100	0.900
2.0	Sorbitol	1280.000	–	1280.000
3.0	Acrysol K140	240.000	–	240.000
4.0	Propylene Glycol	177.000	–	177.000
5.0	Methyl Paraben Sodium	1.000	–	1.000
6.0	Propyl Paraben Sodium	0.250	–	0.250
7.0	Bronopol	0.400	–	0.400
8.0	Chloroform	2.000	–	2.000
9.0	BHT	0.200	–	0.200
10.0	Citric Acid	2.000	–	2.000
11.0	Colour Tartrazine Supra	0.010	–	0.010
12.0	Flavour Mango	5.000 Ltr.	–	5.000 Ltr.

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

Note : *The Required quantity of API is taken as per calculation by using the below mentioned formula.
In above table the quantity of Cholecalciferol is taken with overages 100%.

4.0 BATCH MANUFACTURING PROCESS :
4.1 BULK MANUFACTURING PROCESS-
4.1.1 Take approx. 250.000 liter purified water in manufacturing Vessel & add 1.000 Kg

Methyl paraben sodium , 0.250 Kg Propyl paraben sodium, 0.400 Kg Bronopol and 2.000 Kg Citric acid & mix for 30 min.
4.1.2 Take 177.000 Kg Propylene glycol in vessel & dissolve 0.200 Kg BHT then transfer to manufacturing tank & mix for 10 min.
4.1.3 Take 2.000 Kg Chloroform in vessel & dissolve 0.900 Kg Vitamin D3 then transfer to manufacturing tank & mix for 30 min.
4.1.4 Take 240.000 Kg Acrysol K140 & 1280.000 Kg Sorbitol, add to manufacturing vessel & mix for 30 min..
4.2 pH ADJUSTMENT-
4.3.1 After completion of activity , Check the pH of bulk between 3.0 to 5.0.
4.3 VOLUME MAKEUP & SAMPLING –
4.3.1 Make up the volume up to 2000 liter & mix for 30 min.
4.3.2 Intimate to IPQA to collect the bulk sample for analysis.
4.4 FILTRATION-
4.4.1 After getting QC release, transfer the bulk to storage vessel through filter press.

5.0 YIELD AND ACCOUNTABILITY :
t.01 After completion of process, calculate the % yield(Limits- 99 – 100 % ).

6.0 PRECAUTION :
6.01 Always wear nose mask & hand gloves before starting the manufacturing process. 7.02 Ensure

the Environmental conditions is within limits Temperature – NMT 27 ºC

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