master formula record diclofenac sodium injection

1.0. PRODUCT INFORMATION :

PRODUCT CODE
GENERIC NAME	Diclofenac Sodium Injection
LABEL CLAIM	Each ml contains
	Diclofenac Sodium	25 mg
	Benzyl Alcohol (As preservative)	4%w/v
	Water for Injection	q. s.
BATCH SIZE:	500 ltr.
PRIMARY PACK DECRIPTION	3 ml Clear Glass Ampoule
PRODUCT DECRIPTION	Clear ,Yellowish solution
SHELF-LIFE	24 Months
STORAGE CONDITION	Store in cool dry & dark place.
MFR NO.
MFG. LIC NO.
MARKET

2.0. TABLE OF CONTENT :

Sr. No.	Contents	Page No.
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	Pharmacopeial Status	Label clam	Standard Qty(Kg)	Overages(%)	Batch Qty(Kg)
1.0	Diclofenac Sodium		25mg/ml	12.875Kg.	about 3%	12.875Kg.
2.0	Benzyl Alcohol		4%w/v	20.800 Kg.	–	20.800 Kg.
3.0	Di Sodium EDTA		–	0.500 Kg.	–	0.500 Kg.
4.0	Sodium metabisulphite		–	1.500 Kg.	–	1.500Kg.
5.0	Propylene Glycol			150.00Kg.		150.00Kg.
6.0	Sodium Hydroxide			1.000Kg.*		1.000Kg.*
7.0	Water for injection			Q.S.		Q.S.

* This Quantity Use To adjust pH only.

4.0 CALCULATIONS:

(A) For Diclofenac Sodium:

A.R. No. of Diclofenac Sodium: __________________

Assay of Diclofenac Sodium: __________________

LOD of Diclofenac Sodium: __________________

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

Assay x (100-LOD) x 1000

5.0. BATCH MANUFACTURING PROCESS :
5.1 Ensure That compounding Vessel is cleaned before starting the procedure.
5.2 Collect 500 Liters Water for Injection in a Mixing vessel send BET sample and cool up to 40- 45°C with continuous nitrogen Purging.
5.3 From the step 1st take approx. 50 litres Water for Injection a side in other SS vessel for final volume make up.
5.4 Add and dissolve Di Sodium EDTA with continuous stirring and check the clarity of solution.
5.5 Add and dissolve Sodium metabisulphite with continuous stirring and check the clarity of solution.
5.6 Add and dissolve Benzyl Alcohol with continuous stirring and check the clarity of solution.
5.7 Add and dissolve Diclofenac Sodium with continuous stirring and check the clarity of solution.
5.8 Add and dissolve Propylene Glycol with continuous stirring and check the clarity of solution.
5.9 check the initial ph (pH RANGE 8.1 TO 9.0)
5.10 Adjust pH of bulk solution with 10% sodium hydroxide solution. and finally make up the

volume with W.F.I and then check the final ph.
5.11 Intimate the IPQA to collect Bulk solution and send to QC for analysis.
5.2 FILTRATION :

5.2.1 Ensure that Bulk solution Release from QC Department.
5.2.2 Filter the Bulk solution from Mixing Vessel to Collection Vessel through 0.2 micron sterilized filter.
5.2.3 Check the Pre and Post Filter Integrity.
5.3. FILL VOLUME DETAILS
5.3.1 Fill volume for 3 ml
5.3.2 Standard fill volume -3.2 ml
5.3.3 Lower fill volume -3.1ml
5.3.4 Upper fill volume -3.3ml
5.4. PRECAUTION
5.4.1 Ensure the nitrogen purging throughout the process.
5.4.2 Always use nose mask, hand gloves while processing.
5.4.3 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 :
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%.