master formula record ethamsylate 250 mg injection 2 ml

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3 years ago

master formula record ethamsylate 250 mg injection 2 ml

master formula record ethamsylate 250 mg injection 2 ml batch size: 525 liters

PRODUCT CODE
GENERIC NAME	Ethamsylate injection 250 mg/2 ml
LABEL CLAIM	Each ml. contains
	Ethamsylate .	125 mg
	Water for Injection	q. s.
STANDARD BATCH SIZE:	525 Liters
PRIMARY PACK DECRIPTION	2 ml Amber Glass Ampoule with Blue 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	PRECAUTION
7.0	YIELD AND ACCOUNTABILITY

3.0. BILL OF RAW MATERIAL :

Sr. No.	INGRADIENTS	Label clam	Standard Qty(Kg)	Overages(%)	Batch Qty(Kg)
1.	Ethamsylate	125 mg	67.594 kg	3%	67.594 kg
2.	Sodium Meta BI Sulphate	–	2.625kg	–	2.625 kg
3.	DI Sodium EDTA LR Grade	–	0.262 kg	–	0.262 kg
4.	Methylparaben	–	0.420 kg	–	0.420 kg
5.	Proplyparaben	–	0.105kg	–	0.105 kg
6.	Propylene Glycol (PG)	–	109.20 kg	–	109.2 kg
7.	Hydrochloric Acid ( Hcl)	–	0.125 Ltr.	–	0.125 Ltr.
8.	Sodium Hydroxide Pellets( NAOH)	–	0.125 kg	–	0.125 kg
9.	Water for Injection (WFI)	–	q.s.	–	q.s.

4.0 CALCULATIONS :

LABEL CLAIM:

Each ml Contains:

Ethamsylate B.P. 125 mg

Water for Injection B.P. q.s.

Calculation for Ethamsylate B.P.

A,R.No. :_________________

Assay on Anhy. Basis: __________ % Water………………. %

Ethamsylate B.P. = 125 x Batch Size x100 x100_ =…. ………Kg of Ethamsylate B.P. (X)

— — — Assay x (100-Water) x1000

5.0. BATCH MANUFACTURING PROCESS :

• Ensure That compounding Vessel is cleaned before starting the procedure.
• Collect Water for Injection according to Batch size in a Mixing vessel send BET sample and

cool up to 80- 85°C with continuous nitrogen Purging.
• From the step 1st take Water for Injection a side in other SS vessel according to Batch size for final volume make up.
• Add and dissolve Methylparaben BP with continuous stirring and check the clarity of solution.
• Add and dissolve Proplyparaben BP with continuous stirring and check the clarity of solution.
• Start the cooling water to the jacket of mixing vessel. Start the stirrer and maintain the stirring

speed between 2200 to 2880 RPM and cool the WFI to 45 – 50 °C.
• Add and dissolve DI Sodium EDTA BP with continuous stirring and check the clarity of solution.
• Add and dissolve Sodium Meta BI Sulphate BP with continuous stirring and check the clarity of solution.
• Add and dissolve Ethamsylate BP with continuous stirring and check the clarity of solution.
• Add and dissolve Propylene Glycol (PG) BP with continuous stirring and check the clarity of solution.
• Check the initial ph (PH RANGE 6.2 TO 6.8) 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 2 ml Ampoule:
• Standard fill volume -2.1 ml
• Lower fill volume -2.05 ml
• Upper fill volume -2.15 ml

6.0. 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 & Accessories should be sterilize, at the time of use .

7.0. 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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