master formula record tranexamic acid injection
master formula record tranexamic acid injection batch size: 530 liters
1.0 PRODUCT INFORMATION :
PRODUCT CODE | ||
GENERIC NAME | Tranexamic Acid Injection 100 mg/ml | |
LABEL CLAIM
|
Each ml contains | |
Tranexamic Acid | 100 mg | |
Water for Injection | q. s. | |
STANDARD BATCH SIZE: | 530 Liters | |
PRIMARY PACK DECRIPTION | 5 ml Clear Glass Ampoule with Red Ring | |
PRODUCT DECRIPTION | Clear ,colorless solution | |
STORAGE CONDITION | Store Protected from Light and Moisture |
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 | CALCULATIONS |
5.0 | BATCH MANUFACTURING PROCESS |
6.0 | YIELD AND ACCOUNTABILITY |
3.0. BILL OF RAW MATERIAL :
Sr.
No. |
INGRADIENTS | Label
clam |
Standard
Qty(Kg) |
Overages(%) | Batch Qty(Kg) |
1. | Tranexamic Acid | 100 mg | 55.650 kg | 5% | 55.650 kg |
2. | Sodium Chloride (LR Grade) | – | 3.260
kg |
– | 3.260
kg |
3. | DI Sodium EDTA (LR Grade) | – | 0.530 kg | – | 0.530 kg |
4. | Hydrochloric Acid (HCL) | – | 0.100 ltr | – | 0.100 ltr |
5. | Sodium Hydroxide Pallets | – | 0.100
Kg |
– | 0.100
Kg |
6. | Water For Injection (WFI) | – | Q.S. | – | Q.S. |
4.0 CALCULATIONS :
LABEL CLAIM:
Each ml Contains:
Tranexamic Acid 100 mg
Water for Injection q.s.
Calculation for Tranexamic Acid
- R.No. _________________
Assay on Anhy. Basis: __________ % —- Water………………. %
Tranexamic Acid B.P. = 100 x Batch Size x100 x100_ =…. ………Kg of Tranexamic Acid
– — Assay x (100-Water) x1000
5.0. BATCH MANUFACTURING PROCESS :
• Ensure That compounding Vessel is cleaned before starting the procedure.
• Collect 530 liters Water for Injection in a Mixing vessel send BET sample and cool up to 45- 50°C with
continuous nitrogen Purging.
• From the step 1st take approx. 100 litres Water for Injection a side in other SS vessel for final volume make up.
• Add and dissolve DI sodium EDTA B.P. with continuous stirring and check the clarity of solution.
• Add and dissolve Sodium Chloride B.P. with continuous stirring and check the clarity of solution.
• Add and dissolve Tranexamic Acid B.P.with continuous stirring and check the clarity of solution.
• Check the initial ph (PH RANGE 6.5 TO 8.0) and Adjust pH of bulk solution
with 10% sodium hydroxide/ Hydrochloric Acid (Hcl)solution. and finally make up the volume
with W.F.I and then check the final ph.
• Intimate the IPQA to collect Bulk solution and send to QC for analysis.
5.1 FILTRATION :
• Ensure that Bulk solution Release from QC Department.
• Filter the Bulk solution from Mixing Vessel to Collection Vessel through 0.2 micron sterilized filter.
• Check the Pre and Post Filter Integrity.
5.2 FILL VOLUME DETAILS
• Fill volume for 5 ml
• Standard fill volume -5.3 ml
• Lower fill volume -5.1 ml
• Upper fill volume -5.4 ml
5.3 PRECAUTION
• Ensure the nitrogen purging throughout the process.
• Always use nose mask, hand gloves while processing.
• All the contact parts of the Equipment, Filtration Assembly , Filling M/C parts and
Accessories should be sterilize, at the time of use .
6.0. YIELD AND ACCOUNTABILITY :
• Bulk yield (After filtration) between 98 -100 %.
• After Filling, Sealing and visual Inspection completion the % yield is NLT 95%.
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