master formula record cyproheptadine hcl and tricholine citrate syrup

master formula record cyproheptadine hcl and tricholine citrate syrup Batch Size: 2000 liters

1.0. PRODUCT INFORMATION :

Product Code
Product (Brand) Name	Cyproheptadine Hcl and Tricholine citrate syrup
Generic Name	Cyproheptadine Hcl and Tricholine citrate syrup
Label Claim	Each 5 ml contain
	Cyproheptadine Hcl	2 mg
	Tricholine citrate solution	275 mg
	Sorbitol Solution 70%	q. s.
	Color	As approved color
Primary Pack Description	Filled in Amber color Brut bottle.
Fill Volume	100 ml, 200 ml
Product Description	Light Yellow Syrup filled in Amber color Brut bottle.
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 & CALCULATION
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	Cyproheptadine Hcl*	0.896	–	0.896
2.0	Tricholine citrate Solution*	170.000	–	170.000
3.0	Sorbitol Solution 70%	400.000	–	400.000
4.0	Bronopol	0.400	–	0.400
5.0	Propylene Glycol	60.000	–	60.000
6.0	Aspartame	4.000	–	4.000
7.0	Citric acid	14.700	–	14.700
8.0	Methyl paraben	1.500	–	1.500
9.0	Propyl paraben	0.300	–	0.300
10.0	Sodium saccharin	2.500	–	2.500
11.0	Xanthan gum (Transparent)	2.000	–	2.000
12.0	Col. Caramel	0.020	–	0.020
13.0	Flv. Pineapple	3.000 Ltr.	–	3.000 Ltr.
14.0	Flv. Sweet orange	3.000 Ltr.	–	3.000 Ltr.
15.0	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 Cyproheptadine Hcl and Tricholine Citrate is taken as such basis.

4.0 CALCULATIONS:

(A) For Cyproheptadine Hcl

A.R. No. of Cyproheptadine Hcl

Potency of Cyproheptadine Hcl

LOD of Cyproheptadine Hcl

Required Quantity of Cyproheptadine Hcl (A) = Strength/ml x Batch Size (in Liters) x 100 x 100 Kg

— — – Potency x (100-LOD) x 1000

(B) For Tricholine Citrate

A.R. No. of Tricholine Citrate

Potency of Tricholine Citrate

LOD of Tricholine Citrate

Required Quantity of Tricholine Citrate (B) = 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 PROCESS-
4.1.1 Take approx. 250.000 liter of purified water in manufacturing Vessel and add 14.700 Kg Citric acid, 0.400 Kg

Bronopol, 2.000 Kg Xanthan gum, 4.000 Kg Aspartame, 2.500 Kg Sodium Saccharin, 400.000 Kg Sorbitol

and 170.000* Kg Tricholine citrate & mix it for 30 min. for clear solution.
4.1.2 Take 60.000 Kg Propylene glycol in vessel and dissolve 1.500 Kg Methyl paraben and 0.300 Kg

Propyl paraben then transfer to manufacturing tank & mix for 10 min. for clear solution.
4.1.3 Take approx. 8.000 Ltr. Purified water in vessel & dissolve 0.896 * Kg Cyproheptadine Hcl then transfer

to manufacturing tank and mix for 10 min. for clear solution.
4.1.4 Take approx. 10.000 Ltr. Purified water in vessel & dissolve 0.020 Kg Col. Caramel then transfer

to manufacturing tank and mix for 10 min.
4.1.5 Take 3.000 Ltr. Flv. Pineapple in vessel then transfer to manufacturing tank and mix for 10 min.
4.1.6 Take 3.000 Ltr. Flv. Sweet Orange in vessel then transfer to manufacturing tank and mix for 10 min.
4.2 pH ADJUSTMENT-
4.2.1 After completion of activity ,Check the pH of bulk between 4.0 to 6.0.
4.3 VOLUME MAKEUP & SAMPLING
4.3.1 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.
4.4 FILTRATION –
4.4.1 After getting QC release, transfer the 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. 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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