MFR of Magaldrate Simethicone and Oxetacaine Suspension
master formula record Magaldrate Simethicone and Oxetacaine Suspension batch size 2000 liters
1.0 PRODUCT INFORMATION :
| Product Code | ||
| Product (Brand) Name | Magaldrate, Simethicone & Oxetacaine Suspension | |
| Generic Name | magaldrate, Simethicone & Oxetacaine Suspension | |
| Label Claim | Each 5 ml contain | |
| Magaldrate | 540 mg | |
| Simethicone | 50mg | |
| Oxetacaine | 10 mg | |
| Color | Brilliant blue & tartrazine | |
| Excipients | q. s. | |
| Primary Pack Description | Pet / round bottles. | |
| Product Description | Antacid Oral Suspension. | |
| 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 | CALCULATION |
| 5.0 | BATCH MANUFACTURING PROCESS |
| 6.0 | YIELD AND ACCOUNTABILITY |
3.0. BILL OF RAW MATERIAL :
| Sr.
No. |
RM Code | Ingredients | Qty in
(Kg) |
Overages
(%) |
Qty/batch
(Kg) |
| 1.0 | – | Magaldrate | 216.000 Kg | – | 216.000 Kg |
| 2.0 | – | Chloroform | 0.200 LTR | – | 0.200LTR |
| 3.0 | – | Simethicone | 20.000 Kg | – | 20.000 Kg |
| 4.0 | – | Oxetacaine | 4.000 Kg | – | 4.000 Kg |
| 5.0 | – | Xanthan Gum (329) | 10.000 Kg | – | 10.000 Kg |
| 6.0 | – | Areosil | 4.000 Kg | – | 4.000 Kg |
| 7.0 | – | Methyl Paraben | 4.000 Kg | – | 4.000Kg |
| 8.0 | – | Propyl Paraben | 1.000 Kg | – | 1.000 Kg |
| 9.0 | – | Menthol | 0.200 Kg | – | 0.200 Kg |
| 10.0 | – | Sodium Saccharin | 2.000 Kg | – | 2.000 Kg |
| 11.0 | – | Sodium Hydroxide | 1.500 Kg | – | 1.500 Kg |
| 12.0 | – | Tween – 80 | 4.000Kg | – | 4.000Kg |
| 13.0 | – | Sorbitol | 600.000 Kg | – | 600.000 Kg |
| 14.0 | – | Glycerin | 50.000 Kg | – | 50.000 Kg |
| 15.0 | – | Bronopol | 0.900 Kg | – | 0.900 Kg |
| 16.0 | – | Color Tartrazine | 0.100 Kg. | – | 0.100 Kg. |
| 17.0 | – | Color Briliant Blue | 0.010 Kg | – | 0.010 Kg |
| 18.0 | – | Flv. Pan | 4.000Lit. | – | 4.000Lit. |
| 19.0 | – | Flv. Peppermint | 1.000 Ltr. | – | 1.000 Ltr. |
| 20.0 | – | 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 Magaldrate, Simethicone , Oxetacaine
is taken as such basis
4.0 CALCULATIONS:
(A) For Magaldrate
A.R. No.of Magaldrate : __________________
Potency of Magaldrate : __________________
LOD of Magaldrate : __________________
Required Quantity of Magaldrate = Strength/ml x Batch Size (in Liters) x 100 x 100
Potency x (100-LOD) x 1000
(B) For Simethicone
A.R. No. of Simethicone : __________________
Potency of Simethicone : __________________
LOD of Simethicone : __________________
Required Quantity of Simethicone = Strength/ml x Batch Size (in Liters) x 100 x 100 X 100
Potency x (100-LOD) x 1000 x 30
(C) For Oxetacaine
A.R. No. of Oxetacaine : __________________
Potency of Oxetacaine : __________________
LOD of Oxetacaine : __________________
Required Quantity of Oxetacaine = Strength/ml x Batch Size (in Liters) x 100 x 100
Potency x (100-LOD) x 1000
5.0. BATCH MANUFACTURING PROCESS :
5.1 BULK MANUFACTURING PROCESS-
5.1.1 Take the 150.000 liter of purified water in manufacturing tank & heat it up to 70 ℃ – 75 ℃ then
add 4.000Kg Methyl paraben , 1.000 Kg Propyl paraben, 1.500Kg Sodium Hydroxide, , 0.900 Kg
Bronopol , 2.000 Kg Sodium Saccharin under continuous stirring .
5.1.2 Add 600.000 Kg Sorbitol direct to manufacturing tank under continuous stirring.
5.1.3 Add 10.000 Kg Xanthan Gum direct to manufacturing tank under continuous stirring(20 min).
5.1.4 Add 4.000 Kg Areosil direct to manufacturing tank under continuous stirring(20 min.).
5.1.5 Then cool the bulk below 45℃ .
5.1.6 Take sufficient quantity of purified water in vessel & dissolve 216.000 Kg
Magaldrate & 2.000 Kg PVPK-30and prepare a slurry then through pass with colloidal mill and
transfer it to manufacturing tank under continuous stirring.
5.1.7 Mix the bulk for 20 min. under continue stirring.
5.1.8 Take 50.000 Kg Glycerin & dissolve 4.000 Kg Oxetacaine & prepare a slurry then
through pass with colloidal mill & transfer it to manufacturing tank under continuous stirring.
5.1.9 Mix the bulk for 10 min. under continue stirring.
5.1.10 Add 20.000. Kg Simethicone direct to manufacturing tank continuous stirring(10 min.).
5.1.11 Add the 4.000Kg Tween-80 direct to manufacturing vessel under continuous stirring.
5.1.12 Take the sufficient quantity of Purified water to dissolve the 0.100 Kg
color Tartrazine & 0.010 Kg Briliant
Blue then add to manufacturing tank under continuous stirring.
5.1.13 Add menthol 0.200 kg with 4.000 Lit. Flavour Pan and 1.000 Lit. pipermint direct
to manufacturing vessel under continuous stirring
5.1.14 Add 0.200 Lit chloroform in manufacturing tank under continuous stirring.
5.2 VOLUME MAKEUP-
5.2.1 Make up the volume up to 2000 liter under continuous stirring .
5.3 pH ADJUSTMENT-
5.3.1 After completion of activity , Adjust the pH of bulk between 6.5 to 9.5
5.4 RECIRCULATION-
5.4.1 Recirculate the bulk from top to bottom through homogenizer for 60 min
.
5.4.2 Intimate to IPQA to collect the bulk sample .
5.5 FILTRATION-
5.5.1 Final transfer the bulk to storage vessel through homogenizer with 60# s.s. sieve.
6.0. YIELD AND ACCOUNTABILITY :
After completion of filtration of bulk , calculate the % yield is between 98 – 100 % .
master formula record cyproheptadine hcl and tricholine citrate syrup
master formula record l-carnitine injection
master formula record piroxicam injection
master formula record ranitidine injection
master formula record tranexamic acid injection
master formula record tranexamic acid injection
master formula record cetirizine syrup
MFR of sucralfate oral suspension
Master formula record Quinine Sulphate Suspension
MFR of Paracetamol Phenylephrine Hcl Chlorpheniramine Maleate Drops
master formula record paracetamol oral suspension
master formula record ethamsylate 250 mg injection 2 ml
master formula record ofloxacin oral suspension
master formula record Fluconazole Cream
master formula record ondansetron oral solution
MFR of hydroxyzine hydrochloride oral solution
master formula record vitamin D3 drops
master formula record furazolidone oral suspension
MFR of Clobetasol Propionate cream
master formula record Povidone iodine ointment 5%
MFR of Magaldrate Simethicone and Oxetacaine Suspension
master formula record albendazole oral suspension
master formula record ondansetron injection
master formula record nandrolone decanoate injection
MFR of diclofenac sodium injection