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MQC for the attached scenario

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Hi

 

Attached is the scenario given by the client

 

I guess the MQC @ Process order will be suitable.

 

Experts pls suggest.

 

A.Standard
  formula
1.Aluminum phosphate gel-2%0.6 mg/Ml
2.HBPB (Semi finished)25µg/ml
3.BPDT (Semi finished)50lf/ml
4.BPTT (Semi finished)11lf/ml
5.WPAB (Semi finished)32IOU/ml
6.HITT (Semi finished)22µg/ml
7.Thiomeral BP (already available in all above Semi Finished, remaining will be added0.1g/l
8.Normal
  saline(Sodium chloride BP)
9g/l

 

B. HBPB
  Bulk calculations
HBPB/341A/132250 ml0.99 mg/ml2227.5 mg
Total µg
  required for 540 Liters=540X1000mlX25µg=13500000µg
HBPB/342A/1310065 ml1.1211272.8 mg
in
  mg=13500000µg/1000=13500 mg
12.315
C.BPDT bulk calculationsBPDT/LL/210/132300 ml3300 lf/ml7590000 lf
Total lf
  required for 540 Liters=540X1000mlX50 lf=27000000 lf
BPDT/LL/212/134314 ml4500 lf/ml19413000 lf
6.614
D.BPTT bulk calculationsBPTT-048/20131674 ml3550 lf/ml5942700 lf
Total lf
  required for 540 Liters=540X1000mlX11 lf=5940000 lf
1.674
E.WPAB bulk calculationsWPAB/332/14144.0L120 lf/ml17280000 iou
Total IOU
  required for 540 Liters=540X1000mlX32 IOU=17280000 iou
144
F. HITT Bulk calculationsHITT/MP3/264/143600 ml0.25948 mg/ml934.128 mg
540000X22/1000=11880
  mg
HITT/MP3/265/1419352 ml0.28158 mg/ml5449.13616 mg
HITT/MP3/266/1419518 ml0.25283 mg/ml4934.73594 mg
HITT/MP3/267/142105 ml0.26705 mg/ml562.14025 mg
44.575

 

 

Suggest, can we maintain the base UOM as Litre or Ug/ml.

 

If litre, we can have the characteristics as potency and bring in thi Propotion unit.

 

If we maintain Base UOM as ug/ml, how to arrive this Litre.

 

More detail attached in Excel sheet.

 

BR

Subbu.


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