MFR of methylcobalamin injection
1.0. PRODUCT INFORMATION :
master formula record methylcobalamin injection 220 liters
|GENERIC NAME||Methylcobalamin Injection|
|Each ml contains|
|Water for Injection||q. s.|
|STANDARD BATCH SIZE:||220 liters|
|PRIMARY PACK DECRIPTION||Amber Glass Ampoule|
|PRODUCT DECRIPTION||Red coloured Clear Solution|
|STORAGE CONDITION||Store in cool dry & dark place.|
2.0. TABLE OF CONTENT :
|Sr. No.||Contents||Page No.|
|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||Methylcobalamin||1500 mcg||0.495 Kg.||50%||0.495 Kg.|
|2.0||Benzyl Alcohol||2%v/v||4.400 Ltr.||–||4.400 Ltr.|
|3.0||Di Sodium EDTA||–||0.110 Kg.||–||0.110 Kg.|
|4.0||Sodium Acetate||–||0.440 Kg.||–||0.440 Kg.|
|5.0||Glacial Acetic Acid||0.396Ltr||0.396Ltr|
|6.0||Water for injection||Q.S.||Q.S.|
Note : The Required quantity of API is taken as per calculation by using the below mentioned formula.
In above table the quantity of Methylcobalamin is taken as such basis.
A.R. No. Methylcobalamin: __________________
Assay of Methylcobalamin: __________________
LOD of Methylcobalamin: __________________
Required Quantity of Methylcobalamin = label claim x Batch Size (in Liters) x 100 x 100
Assay x (100-LOD) x 1000×1000
5.0. BATCH MANUFACTURING PROCESS :
5.1 Ensure That compounding Vessel is cleaned before starting the procedure.
5.2 Collect 220 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 Acetate IP with continuous stirring and check the clarity of solution.
5.6 Add and dissolve Methylcobalamin IP with continuous stirring and check the clarity of solution.
5.7 Add and dissolve Benzyl Alcohol with continuous stirring and check the clarity of solution.
5.8 check the initial ph (pH RANGE 3.3 TO 5.5).
5.9 Adjust pH of bulk solution with 10% Glacial Acetic Acid. 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 1 ml
5.3.2 Standard fill volume -1.1 ml
5.3.3 Lower fill volume -1.05 ml
5.3.4 Upper fill volume -1.15 ml
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 NLT 98-100%
6.1.2 After Filling, Sealing and visual Inspection completion the % yield is NLT 95%.