master formula record etofylline and theophylline injection

1.0. PRODUCT INFORMATION:

master formula record etofylline and theophylline injection Batch Size: 420 Liters

PRODUCT CODE
GENERIC NAME	Etofylline And Theophylline Injection
LABEL CLAIM	Each ml contains
	Etofylline	84.7 mg
	Theophylline anhydrous Eq to Theophylline hydrate	25.3 mg
	Water for Injection	q. s.
STANDARD BATCH SIZE:	420 Liters
PRIMARY PACK DECRIPTION	2 ml Amber Glass Ampoule With Blue Dot
PRODUCT DECRIPTION	Clear ,colorless solution
STORAGE CONDITION	Store in cool, dry & dark place.

2.0 TABLE OF CONTENT:

Sr. No.	Contents
1.	PRODUCT INFORMATION
2.	TABLE OF CONTENT
3.	BILL OF RAW MATERIAL
4.	RAW MATERIAL CALCULATION
5.	BATCH MANUFACTURING PROCESS
6.	YIELD AND ACCOUNTABILITY

3.0. BILL OF RAW MATERIAL:

Sr. No.	INGRADIENTS	Label clam	Standard Qty(Kg)	Overages(%)	Batch Qty(Kg)
1.	Etofylline	84.7 mg	37.353 Kg.	5%	37.353 Kg.
2.	Theophylline	25.3 mg	11.157 Kg.	–	11.157 Kg.
3.	Sodium chloride	–	3.780 Kg.	–	3.780 Kg.
4.	Water for injection	–	Q.S.	–	Q.S.

4.0. CALCULATIONS:
LABEL CLAIM:
Each ml Contains:
Etofylline – 84.7 mg

Theophylline anhydrous

Eq to Theophylline hydrate – 25.3 mg

Water for injection – Q.S.

Calculation for Etofylline and Theophylline

R.No. One:_________________

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

Etofylline = Label ClaimxBatch Size (In Liters) x100 x100 =…. Kg of Etofylline

— — Assay x (100-water) x1000

— Theophylline

R.No. One:____________

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

Theophylline BP = Label ClaimxBatch Size (In Liters) x100 x100 =…. Kg of Theophylline

— — -Assay x (100-water) x1000

5.0. BATCH MANUFACTURING PROCESS:

Ensure That compounding Vessel is cleaned before starting the procedure.
Collect 420 Liters 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 approx. 50 litres Water for Injection a side in other SS vessel for final volume make up.
Add and dissolve Etofylline BP with continuous stirring and check the clarity of solution.
Add and dissolve Theophylline BP with continuous stirring and check the clarity of solution.
Add and dissolve Sodium chloride BP with continuous stirring and check the clarity of solution.
Check the initial ph (PH RANGE 4.5 TO 6.0) 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.
5.2 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.
5.3 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
5.4 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%.

master formula record cyproheptadine hcl and tricholine citrate syrup

master formula record l-carnitine injection

master formula record piroxicam injection

master formula record ranitidine injection

master formula record tranexamic acid injection

master formula record cetirizine syrup

MFR of sucralfate oral suspension

Master formula record Quinine Sulphate Suspension

MFR of Paracetamol Phenylephrine Hcl Chlorpheniramine Maleate Drops

master formula record paracetamol oral suspension

master formula record ethamsylate 250 mg injection 2 ml

master formula record ofloxacin oral suspension