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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