master formula record multivitamin with l-lysine hydrochloride and zinc drops

1.0. PRODUCT INFORMATION : Standard Batch Size: 2000 liters

Product Code
Product (Brand) Name	Multivitamin with L-Lysine Hydrochloride & Zinc Drops (For Therapeutic Use)
Generic Name	Multivitamin with L-Lysine Hydrochloride & Zinc Drops (For Therapeutic Use)
Label Claim	Each ml contains
	Vitamin A	2500 IU
	Vitamin D3	200 IU
	Vitamin E USP	2.5 IU
	Vitamin B1 USP	1 mg
	Vitamin B2	1 mg
	Vitamin B3	10 mg
	Vitamin B6	0.5 mg
	Vitamin C	25 mg
	L-Lysine Hydrochloride BP	3 mg
	Zinc Sulphate	3 mg
	Colour	As per approved color
	Excipients	q. s.
Primary Pack Description	Filled in amber color brut bottles.
Product Description	Light yellow color oral syrup filled in amber color brut bottles.
Fill Volume	15 ml, 30 ml
Shelf-life	36 Months
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	Vit. A	0.600	–	0.600
2.0	Vit. d3	0.020	–	0.020
3.0	Vit. E	5.000	–	5.000
4.0	Pyridoxine HCL	1.200	–	1.200
5.0	Vit. B1	2.400	–	2.400
6.0	Vit. B2 Phosphate	3.200	–	3.200
7.0	Vit. B3	24.00	–	24.00
8.0	Vit. C	50.000	–	50.000
9.0	L- Lysine Hcl	6.000	–	6.000
10.0	Zinc Sulphate monohydrate	16.440	–	16.440
11.0	Sucrose	600.000	–	600.000
12.0	Aspartame	2.000	–	2.000
13.0	Sodium Benzoate	2.000	–	2.000
14.0	Xanthan gum (transparent)	4.500	–	4.500
15.0	Bronopol	2.000	–	2.000
16.0	Disodium edetate	2.000	–	2.000
17.0	Methyl Paraben Sodium	2.000		2.000
18.0	Propyl Paraben Sodium	0.500		0.500
19.0	Sodium Bicarbonate	50.000		50.000
20.0	Tween-80	56.000		56.000
21.0	Citric acid	2.000		2.000
22.0	Chloroform	2.000		2.000
23.0	Sodium saccharin	2.000		2.000
24.0	Flavour Raspberry	4.000 Ltr.		4.000 Ltr.
25.0	Color Caramel	0.010		0.010
26.0	Purified water	Q.S.	–	Q.S.

Note : *The Required quantity of API is taken after added appropriate overages to compensate the loss.

4.0. BATCH MANUFACTURING PROCESS :

4.2.12 Take 56.000 Kg Tween-80 & add 0.600 Kg Vitamin A, 5.000 Kg Vitamin E & transfer to manufacturing vessel mix for 30 min.
4.2.13 Take approx. 10.000 Ltr. purified water in vessel & dissolve 1.200 Kg Pyridoxine Hcl and add to manufacturing vessel mix for 10 min.
4.2.14 Take approx. 10.000 Ltr. Warm Purified water in vessel & dissolve 2.400 Vitamin B1 & add to manufacturing vessel mix for 10 min.
4.2.15 Take approx. 10.000 Ltr. Purified water & dissolve 3.200 Kg Vitamin B2 and add to manufacturing vessel mix for 10 min.
4.2.16 Take approx. 40.000 Ltr. Purified water in vessel & dissolve 24.000 Kg Vitamin B3 and add to manufacturing vessel mix for 10 min.
5.2.17 Take approx. 80.000 Ltr. Warm Purified water in vessel & dissolve 50.000 Kg Vitamin C and add to manufacturing vessel mix for 10 min.
4.2.18 Take approx. 20.000 Ltr. Warm Purified water in vessel & dissolve 6.000 Kg L-Lysine & add to manufacturing vessel mix for 10 min.
4.2.19 Take approx. 40.000 Ltr. Warm Purified water in vessel & dissolve 16.440 Kg Zinc sulphate and add to manufacturing vessel mix for 10 min.
4.2.20 Take 2.000 Ltr. Chloroform in vessel & dissolve 0.020 Kg Vitamin D3 and add to manufacturing vessel mix for 10 min.
4.2.21 Take approx. 10.000 Ltr. Purified water in vessel & dissolve 0.010 Kg Col. caramel and add to manufacturing vessel mix for 10 min.

4.2.22 Take 4.000 Ltr. Flv. Raspberry in vessel & add to manufacturing vessel mix for 5 min.
4.3 pH ADJUSTMENT-
4.3.1 After completion of activity , Check the pH of bulk between 4.0 to 6.8
4.4 VOLUME MAKEUP-
4.4.1 Makeup the volume up to 2000 litters with Purified Water and mix for 30 min.
4.5 BULK SAMPLE COLLECTION-
4.5.1 Intimate to IPQA to collect the bulk sample for analysis.
4.6 FILTRATION-
4.6.1 After getting QC release, filter the final bulk to storage vessel through filter press.

5.0. YIELD AND ACCOUNTABILITY :
5.1 After completion of process, calculate the % yield(Limits- 99 – 100 % ).
6.0. PRECAUTION :
76.1 Always wear nose mask & hand gloves before starting the manufacturing process.
6.2.1 Ensure the Environmental conditions is within limits Temperature – NMT 27 ºC

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