master formula record tranexamic acid injection
master formula record tranexamic acid injection batch size: 530 liters
1.0 PRODUCT INFORMATION :
|GENERIC NAME||Tranexamic Acid Injection 100 mg/ml|
|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 :
|2.0||TABLE OF CONTENT|
|3.0||BILL OF RAW MATERIAL|
|5.0||BATCH MANUFACTURING PROCESS|
|6.0||YIELD AND ACCOUNTABILITY|
3.0. BILL OF RAW MATERIAL :
|1.||Tranexamic Acid||100 mg||55.650 kg||5%||55.650 kg|
|2.||Sodium Chloride (LR Grade)||–||3.260
|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
|6.||Water For Injection (WFI)||–||Q.S.||–||Q.S.|
4.0 CALCULATIONS :
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
• 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%.