master formula record ranitidine injection

master formula record ranitidine injection Batch Size: 420 Liters

PRODUCT CODE
GENERIC NAME	Ranitidine Injection
LABEL CLAIM	Each ml contains
	Ranitidine Hydrochloride Eq. to Ranitidine	25 mg
	Phenol (As Preservative)	5 mg
	Buffered aqueous base	Q.S.
STANDARD BATCH SIZE:	420 Liters
PRIMARY PACK DECRIPTION	2 ml Amber Glass Ampoule With Blue Ring
PRODUCT DECRIPTION	Clear, Colorless solution
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	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)
1.0	Ranitidine Hydrochloride	25 mg/ml	12.304 Kg.	5%	12.304 Kg.
2.0	Phenol	5 mg	2.100 Kg.	–	2.100 Kg.
3.0	Di Sodium Hydrogen Phosphate	–	1.008 Kg.	–	1.008 Kg.
4.0	Potassium Di Hydrogen Ortho Phosphate	–	0.420 Kg.	–	0.420 Kg.
5.0	Water for injection	–	Q.S.	–	Q.S.

4.0 CALCULATIONS:

LABEL CLAIM:
Each ml Contains:
Ranitidine Hydrochloride BP 28 mg

Eq. to Ranitidine 25 mg

Phenol BP 5 mg (As Preservative)

Buffered aqueous base Q.S.

Calculation for Ranitidine Hydrochloride BP

R.No. _________________

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

Ranitidine = Label ClaimxBatch Size (In Liters) x100 x100 x factor (1.116) =…. ……Kg of Ranitidine

— — — Assay x (100-water) x1000

5.0. BATCH MANUFACTURING PROCESS:

• Ensure That compounding Vessel is cleaned before starting the procedure.
• Collect Water for Injection in a Mixing vessel send BET sample and cool up to 50- 55°C with continuous nitrogen Purging.
• From the step 1st take Water for Injection a side in other SS vessel for final volume make up.
• Add dispensed quantity of Di Sodium Hydrogen Phosphate to the mixing vessel and heat up to 50-55°C. Under continuous stirring
• Add dispensed quantity Potassium Di Hydrogen Ortho Phosphate to the mixing vessel under continuous stirring.
• Add dispensed quantity Ranitidine Hydrochloride with continuous stirring and check the clarity of solution.
• Check the ph (pH RANGE 6.7 TO 7.3). . Stop the stirrer and check the volume of the solution in mixing vessel. Make up the volume to required batch size
• Intimate the IPQA to collect Bulk solution and send to QC for analysis.
6.1 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
• Standard fill volume -2.1 ml
• Lower fill volume -2.05 ml
• Upper fill volume -2.15 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 & 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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