Calculation of API (active pharmaceutical ingradient ) in pharma manufacturing

     Calculation of API of different AR no.

1.  A.R No.: rm0001 (let)

Assay on anhydrous basis =A1

Water1 content : W1%(let)

Required qty. Of API per Tablet = 

Label claim x 100 x100x factor(if applicable )

                   Assay1x (100-w1% )

           = label claimx100x100x(f)

                    A1x(100-w1%)

                = A1 mg.

2.  A.R No.: rm0002 (let) 

Assay on anhydrous basis =A2 mg

Water1 content : W2%(let)

Required qty. Of API per Tablet =

Label claim x 100 x100xfactor(if applicable)

            Assay2x (100-water2)

           = label claimx100x100xf

                    A1x(100-w1%)

                = A2 mg.

3.  A.R No.: rm0003(let) 

Assay on anhydrous basis =A3%

Water1 content : W3%(let)

Required qty. Of API per Tablet =

Label claim x 100 x100xfactor(if applicable)

              Assay3x (100-water content %)

           = label claimx100x100xf

                    A3x(100-w3%)

                = A3 mg.


Now API required per tablet from 1st A. R No.

A1 x batch size(no.)/1000x1000 =M kg

If required qty is not sufficient from 1st A. R no.

Then take from 2nd A. R no.:

i. Available qty from 1st A. R no= P kg

ii. So no. of tablet could be manufactured 

     from 1st A. R no. as per avialable balance 

    =  p x 1000 x 1000/A1 =......n1

iii. Remaining tablets from 2nd A. R. No.=

 Batch size -n1=......n2(no. of tablets to be                     manufactured from 2nd A. R no.)       

   API required per tablet from 2nd A. R no.=

     A2 mg (see above calculation )

Hence API required from this A. R no. for n2 no. of tablets will be =n2 x A2=..... (Q )kg

 

If even required qty is not sufficient from2nd  A. R no.

Then take from 3rd A. R no.:

So no. of tablet could be manufactured from 2ndA. R no. as per avialable balance=... (R) kg

    =  R x 1000 x 1000/A2=..... (n3)

iii. Remaining tablets from 3rd A. R. No.=

      Batch size -(n2+n3)= n4

   API required per tablet from 3rd A. R no.=

     A3 mg (see above calculation )

Hence wt. of API required from this A. R no. for n4 no. of tablets will be =n4x A3=S kg.

Actual qty of API in a batch = P+Q+S=  T kg

Qty of compensated expient will be required =

  Actual qty (in kg)-standard qty=.......


                  





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  Calculation of Active pharmacetical ingredient: Formula: Batch size x Label claim x factor x 100 x 100 ---------------------------------------------------------------------Assay % of API X (100-LOD)X 1000 X 1000 =....... (Z) If quantity of 1st A. R no. is not sufficent then : Avialable balance of 1st A. R no............ Kg(A) Quantity required to be used from 2nd A. R No. =Z-A=...... kg(B) Calculation for 2nd A. R No. =Bx1st Assay API x 1st(100-LOD%) -------------------------------------------------=........Kg (C)  Assay % of 2nd API x 2nd(100- LOD%) Total quantity of API to be dispensed= A+C=........... Kg.
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