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%.

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