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Calculate the maximum drug concentration if the drug completely dissolves in the dissolution medium (typically 900mL). 

The result will be used repeatedly in many subsequent calculators for preparation of standards. 

 

Calculate the maximum drug concentration if the drug completely dissolves in the dissolution medium (typically 900mL). 

The result will be used repeatedly in many subsequent calculators for preparation of standards. 

 

Amount of drug in dosage form

Medium volume

Units

Results:

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Determine the target concentration which is required to prepare the primary standard (PS).

 

Determine the target concentration which is required to prepare the primary standard (PS).

 

Amount of drug in dosage form

Results:

-
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The purpose of the primary standard is to serve as a concentrated standard/stock for subsequent preparation of secondary standard, multiple standards or dilutions of know drug concentrations.

Primary Standard (PS) Preparation

The purpose of the primary standard is to serve as a concentrated standard/stock for subsequent preparation of secondary standard, multiple standards or dilutions of know drug concentrations.

Primary Standard (PS) Preparation

Drug Substance Purity

Actual weight of drug substance

Volumetric Flask

Results:

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Secondary standard is required to improve the accuracy of drug concentration and has an intermediate drug concentration. For the preparation of secondary standard, dilution of primary standard is carried out.

Secondary Standard (SS) Preparation

Secondary standard is required to improve the accuracy of drug concentration and has an intermediate drug concentration. For the preparation of secondary standard, dilution of primary standard is carried out.

Secondary Standard (SS) Preparation

Max Drug Concentration

Concentration of PS

Volumetric Flask

Results:

-
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The highest and lowest drug concentration standards are used to check whether the analytical HPLC method can accurately and reliably quantify the drug at both extremes of concentration. For the preparation of HD and LD, dilution of secondary standard is carried out.  

HD and LD preparation

The highest and lowest drug concentration standards are used to check whether the analytical HPLC method can accurately and reliably quantify the drug at both extremes of concentration. For the preparation of HD and LD, dilution of secondary standard is carried out.  

HD and LD preparation

Select Dilution Ratio

Max Drug Concentration

Concentration of SS

Volumetric Flask

Results:

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