master formula record piroxicam injection
1.0 PRODUCT INFORMATION:
master formula record piroxicam injection 20 mg/ml batch size 240 lts
|GENERIC NAME||Piroxicam Injection 20 mg/ml|
|Each ml contains:|
|Benzyl Alcohol||2% v/v|
|Water For Injection||Q.S.|
|STANDARD BATCH SIZE:||240 Liters|
|PRIMARY PACK DECRIPTION||1 ml Amber Glass Ampoule With White Ring|
|PRODUCT DECRIPTION||Clear , Yellowish solution|
|STORAGE CONDITION||Store below 30°C.Protect from light.|
2. TABLE OF CONTENT:
|2||TABLE OF CONTENT|
|3||BILL OF RAW MATERIAL & CALCULATION|
|5||BATCH MANUFACTURING PROCESS|
|6||YIELD AND ACCOUNTABILITY|
3. BILL OF RAW MATERIAL:
|1.||Piroxicam||20 mg||5.040 Kg.||5%||5.040 Kg.|
|2.||Benzyl Alcohol||2% v/v||4.800 Ltr.||–||4.800 Ltr.|
|3.||Ethanol||12.6% v/v||30.240 Ltr.||–||30.240 Ltr.|
|4.||Sodium Hydroxide||–||1.399 Kg.||–||1.399 Kg.|
|5.||Nicotinamide||–||12.600 Kg.||–||12.600 Kg.|
|6.||Propylene Glycol||–||168.000 Kg.||–||168.000 Kg.|
|7.||Hydrochloric Acid||–||0.840 Ltr.||–||0.840 Ltr.|
|8.||Water for inj.(WFI)||–||Q.S.||–||Q.S.|
4.0 Calculation for Piroxicam
- R.No. One:_________________
Assay on Anhy. Basis: __________ % Water………………. %
Piroxicam BP = 20 x Batch Size x100 x100__=…. ………Kg of Piroxicam
— — — – Assay x (100-Water) x1000
5.0 . BATCH MANUFACTURING PROCESS:
Ensure That compounding Vessel is cleaned before starting the procedure.
Collect Water for Injection Batch Size according in a Mixing vessel (Temp 80-85°C)send BET sample with continuous nitrogen Purging.
From the step 1st take Water for Injection Batch Size according a side in other SS vessel for final volume make up.
Add and dissolve Piroxicam BP with continuous stirring and check the clarity of solution.
Add and dissolve Ethanol BP with continuous stirring and check the clarity of solution.
Add and dissolve Nicotinamide BP with continuous stirring and check the clarity of solution.
Add and dissolve Benzyl Alcohol BP with continuous stirring and check the clarity of solution.
Add and dissolve Propylene Glycol BP with continuous stirring and check the clarity of solution.
Check the initial ph and adjust ph with 10% Hydrochloric Acid and Sodium Hydroxide BP solution .
(Ph Limit -8.5to 10.0) and finally make up the volume with WFI.
Intimate the IPQA to collect Bulk solution and send to QC for analysis.
Bulk Solution pH Limit -8.5 to 10.0.
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 1 ml Ampoule:
Standard fill volume -1.2 ml
Lower fill volume -1.15 ml
Upper fill volume -1.25 ml
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%.