MFR of Paracetamol Phenylephrine Hcl Chlorpheniramine Maleate Drops

Master formula record Paracetamol Phenylephrine Hcl Chlorpheniramine Maleate Drops

Master formula record Paracetamol Phenylephrine Hcl Chlorpheniramine Maleate Drops Size: 2000 liters

Product Code
Product (Brand) Name	Paracetamol, Phenylephrine Hcl, Chlorpheniramine Maleate Drops
Generic Name	Paracetamol, Phenylephrine Hcl, Chlorpheniramine Maleate Drops
Label Claim	Each ml contains
	Paracetamol IP	250 mg
	Phenylephrine Hcl IP	5 mg
	Chlorpheniramine Maleate IP	0.5 mg
	Color	Ponceau 4R
	Excipients	q. s.
Primary Pack Description	Filled in amber color pet bottles.
Product Description	A Reddish pink color oral drop filled in amber color 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 & CALCULATION
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	Paracetamol *	250.000	–	250.000
2.0	Phenylephrine Hcl *	10.000	–	10.000
3.0	Chlorpheniramine Malate *	1.000	–	1.000
4.0	Sorbitol 70% Solution	200.000	–	200.000
5.0	Sodium Methyl Paraben	2.000	–	2.000
6.0	Sodium Methyl Paraben	0.500	–	0.500
7.0	Propylene Glycol	700.000	–	700.000
8.0	Poly Ethylene Glycol-400	700.00	–	700.00
9.0	Bronopol	0.400	–	0.400
10.0	Sodium Benzoate	2.000	–	2.000
11.0	Aspartame	3.000	–	3.000
12.0	Sodium saccharin	3.000	–	3.000
13.0	Citric acid	2.000	–	2.000
14.0	Col. Ponceau 4R	0.040	–	0.040
15.0	Flv. strawberry	4.000 Ltr.	–	4.000 Ltr.

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

Note : *The Required quantity of API is taken as per calculation by using the below mentioned formula.

In above table the quantity of Paracetamol, Phenylephrine Hcl, & Chlorpheniramine Maleate is taken as such basis.

CALCULATIONS:

(A) For Paracetamol

A.R. No. of Paracetamol

Potency of Paracetamol

LOD of Paracetamol

Required Quantity of Paracetamol (A ) = Strength/ml x Batch Size (in Liters) x 100 x 100 kg

— — — Potency x (100-LOD) x 1000

(B) For Phenylephrine Hcl

A.R. No. of Phenylephrine Hcl

Potency of Phenylephrine Hcl

LOD of Phenylephrine Hcl

Required Quantity of Phenylephrine Hcl (B ) = Strength/ml x Batch Size (in Liters) x 100 x 100 kg

— — — Potency x (100-LOD) x 1000

A.R. No. of Chlorpheniramine maleate

Potency of Chlorpheniramine maleate

LOD of Chlorpheniramine maleate

Required Quantity of Chlorpheniramine maleate (C ) = 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 200.000 Kg Sorbitol in manufacturing Vessel & add 2.000 Kg Methyl paraben sodium, 0.500 Kg

Propyl paraben sodium, 2.000 Kg Citric acid, 3.000 Kg Aspartame, 3.000 Kg Sodium Saccharin, 2.000 Kg

Sodium benzoate & mix it for 30 min. for clear solution.
4.1.2 Take 700.000 Kg Propylene glycol & 700.000 Kg PEG-400 in vessel & heat it then dissolve 250.000Kg

Paracetamol then transfer to manufacturing tank & mix for 20 min. for clear solution.
4.1.3 Take approx. 30.000 Ltr. Purified water in vessel & dissolve 10.000 Kg Phenylephrine 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 1.000 Kg Phenylephrine Hcl then transfer to manufacturing

tank and mix for 10 min. for clear solution.
4.1.5 Take approx. 10.000 Ltr. Purified water in vessel & dissolve 0.020 Kg Col. Ponceau 4R then transfer to

manufacturing tank and mix for 10 min.
4.1.6 Take 4.000 Ltr. Flv. Strawberry in vessel then transfer to manufacturing tank and mix for 10 min.
4.2 pH ADJUSTMENT-
4.2.1 After completion of activity , Adjust 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 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 :
5.1 After completion of process, calculate the % yield. (Limits- 99 – 100 % ).

6.0. PRECUATION :
6.1 Always wear nose mask and hand gloves before starting the manufacturing process.

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