Potency calculation of Active Pharmaceutical Ingredient (API) for lab development trial, MFR (or) BMR


CONTENTS

  • Potency calculation based on API assay.
  • Conversion factor calculation.
  • Calculation for one batch of API used.
  • Calculation for two batches of API used.

Potency calculation based on API assay

NOTE: Assay of API consider 100%, If assay of API is more than 100%

Conversion factor calculation

NOTE: Conversion factor will directly multiply into standard quantity of API required.

When conversion factor used:

If API used in the formulation as salt form, but label claim is without salt form.

e.g.: Product name: Amlodipine Tablets 10 mg

        Label claim: Each tablet contains,

                               Amlodipine besylate equivalent to amlodipine….10 mg

Conversion factor not to be used:

If API used in the formulation as salt form, but label claim is also salt form.

e.g.: Product name: Diclofenac Sodium DR tablets 75 mg

        Label Claim: Each delayed-release tablet contains

                                Diclofenac Sodium…..75 mg

Conversion not to be used in case of API used as monohydrate form/ Dihydrate form/ Trihydrate form

e.g.: Product name: Azithromycin Tablets 500 mg

        Label Claim: Each tablet contains, Azithromycin dihydrate equivalent 

                                to Azithromycin……500 mg


Calculation for one batch of API used in formulation

Potency calculation based on API assay on as is basis (For one batch of API to be used in formulation)

Actual quantity of API required =

Actual quantity of filler required = (Standard quantity of API required + Standard quantity of filler required) – Actual quantity of API required = __________ kg


Calculation for two batches of API used

Potency calculation based on API assay on as is basis (For two batches of API to be used in formulation)

Potency calculation 1st batch No. =

Remaining quantity of API required from 2nd Batch No. = Total quantity of API required – a = _________ kg (b)

Potency calculation 2nd Batch No. =

Actual total quantity of API required (c) = Quantity of 1st Batch available + B = __________ kg.

Actual quantity o filler required = Standard quantity of API required + Standard quantity of Filler – Actual total quantity of API required (c) = __________ kg.


 

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