master formula record ondansetron injection

MFR of ondansetron injection 500 liters

1.0 PRODUCT INFORMATION :

PRODUCT NAME	Ondansetron Injection
GENERIC NAME	Ondansetron Hydrochloride Injection
LABEL CLAIM	Each ml contains
	Ondansetron Hydrochloride Eq to Ondansetron	2 mg
	Water for Injection	q. s.
STANDARD BATCH SIZE:	500 ltr.
PRIMARY PACK DECRIPTION	2 ml Ampoule
PRODUCT DECRIPTION	Clear ,colorless solution

2.0. TABLE OF CONTENT :

Sr. No.	Contents
1.0.	PRODUCT INFORMATION
2.0	TABLE OF CONTENT
3.0	BILL OF RAW MATERIAL & CALCULATION
4.0	BATCH MANUFACTURING PROCESS
5.0	PRECAUTION
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	Ondansetron hydrochloride eqv to ondansetron	2mg/ml	1.275 kg	2%	1.275 kg
2.0	Tri sodium citrate	–	0.165 kg	–	0.165 kg
3.0	Sodium chloride –	–	4.149 kg	–	4.149 kg
4.0	Citric acid monohydrate –	–	0.230 kg	–	0.230 kg
5.0	Water for injection		Q.S.

Note: : The material has been taken equivalent to its 100% assay on as is bases considering

the minimum assay 98.5% and maximum LOD 5%

CALCULATIONS:
(A) For ondansetron hydrochloride Hydrochloride
A.R. No. of ondansetron Hydrochloride : __________________
Assay of ondansetron Hydrochloride : __________________
LOD of ondansetron Hydrochloride : __________________
Factor ; : __________________

Required Quantity = label claim x Batch Size (in Liters) x 100 x 100x factor

Assay x (100-LOD) x 1000

4.0. BATCH MANUFACTURING PROCESS :

4.0.1 Ensure That compounding Vessel is cleaned before starting the procedure.
4.0.2 Collect 500 Liters Water for Injection in a Mixing vessel send BET sample and cool up to 40- 45°C with continuous nitrogen Purging.
4.0.3 From the step 1st take approx. 50 litres Water for Injection a side in other SS vessel for final volume make up.
4.0.4 Add and dissolve CITRIC ACID with continuous stirring and check the clarity of solution.
4.0.5 Add and dissolve ONDANSETRON with continuous stirring and check the clarity of solution.
4.0.6 Add and dissolve SODIUM CHLORIDE with continuous stirring and check the clarity of solution.
4.0.7 Add and dissolve TRI SODIUM CITRATE with continuous stirring and check the clarity of solution.
4.0.8 check the initial ph (PH RANGE 3.3 TO 4.0) and finally make up the volume with w.f.i. and then check the final ph.
4.0.9 Intimate the IPQA to collect Bulk solution and send to QC for analysis.
4.2 FILTRATION :
4.3.1 Ensure that Bulk solution Release from QC Department.
4.3.2 Filter the Bulk solution from Mixing Vessel to Collection Vessel through 0.2 micron sterilized filter.
4.3.3 Check the Pre and Post Filter Integrity.
4.3. FILL VOLUME DETAILS
4.3.4 Fill volume for 2 ml
4.3.5 Standard fill volume -2.10 ml
4.3.6 Lower fill volume -2.05ml
4.3.7 Upper fill volume -2.15ml
5.0 . PRECAUTION
5.1 Ensure the nitrogen purging throughout the process.
5.2 Always use nose mask, hand gloves while processing.
5.3 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 :
6.1.1 Bulk yield (After filtration) between 98 -100 %.
6.1.2 After Filling, Sealing and visual Inspection completion the % yield is NLT 95%.

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