master formula record nandrolone decanoate injection
MFR of nandrolone decanoate injection 240 liters
1.0 PRODUCT INFORMATION :
|GENERIC NAME||Nandrolone Decanoate Injection|
|Each ml contains|
|Nandrolone Decanoate||25 mg|
|Oily Base||q. s.
|STANDARD BATCH SIZE:||240 liters|
|PRIMARY PACK DECRIPTION||1 ml Clear Glass Ampoule|
|PRODUCT DECRIPTION||Clear, Yellowish Solution|
|STORAGE CONDITION||Store in cool dry & dark place.|
2.0. TABLE OF CONTENT :
|2.0||TABLE OF CONTENT|
|3.0||BILL OF RAW MATERIAL|
|5.0||BATCH MANUFACTURING PROCESS|
|6.0||YIELD AND ACCOUNTABILITY|
3.0. BILL OF RAW MATERIAL :
|1.0||Nandrolone Decanoate||25 mg||6.300 Kg.||5%||6.300 Kg.|
|2.0||Benzyl Alcohol||2%v/v||4.800 Ltr.||–||4.800 Ltr.|
|4.0||*Ethyl oleate||–||10.000 Ltr.||–||10.000 Ltr.|
Note : The Required quantity of API is taken as per calculation by using the below mentioned formula.
In above table the quantity of Nandrolone Decanoate is taken as such basis.
• * This Qty. is used for Rinsing purposes only.
Calculation for Nandrolone Deaconate IP:
01. A.R.No. : _________________
Assay on Anhy. Basis: __________ % Water………………. %
Nandrolone Decanoate = 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 MixingVessel is cleaned before starting the procedure.
5.2 Take 240 Ltr. Ethyl Oleate IP in mixing vessel.
5.3 Heat the oil base 121ºC for one Hour Hold.
5.4 Cool down the temperature of Oil base up to 80ºC. the stirring speed between 2500 to 2880 RPM.
5.5 Transfer approx. 40 ltr. Of Ethyl Oleate IP from the mixing vessel to cleaned S.S container.
5.6 Add and dissolve. 12.600 Kg Nandrolone Decanoate IP in Oil Base with continues stirring .
5.7 Add and dissolve Benzyl Alcohol with continuous stirring and check the clarity of solution.
5.8 Stop the stirrer and check the volume of the solution in mixing vessel.
5.9 Stir the bulk solution for 15 minutes. Stirrer speeds limit (2500 – 2880 RPM).
5.10 Intimate the IPQA to collect Bulk solution and send to QC for analysis.
5.1.0 FILTRATION :
5.1.1 Ensure that Bulk solution Release from QC Department.
5.1.2 Filter the Bulk solution from Mixing Vessel to Collection Vessel through 0.2 micron sterilized filter.
5.1.3 Check the Pre and Post Filter Integrity.
5.2.0 FILL VOLUME DETAILS :
5.2.1 Fill volume for 1 ml
5.2.2 Standard fill volume -1.2 ml
5.2.3 Lower fill volume -1.1 ml
5.2.4 Upper fill volume -1.3 ml
5.3.0 PRECAUTION :
5.3.1 Ensure the nitrogen purging throughout the process.
5.3.2 Always use nose mask, hand gloves while processing.
5.3.3 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 Bulk yield (After filtration) between NLT 98-100% .
62 After Filling, Sealing and visual Inspection completion the % yield is NLT 95%.