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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

 

 

 

 

 

 

(C)                 For Chlorpheniramine maleate

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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