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Learning Centre

ALL NEW! Background Biorelevant media Analysis Filters Dissolution tips Guides and Calcs Dissolution

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Two stage biorelevant dissolution of Stugeron® (cinnarizine 15 mg)

This post describes the results of two stage biorelevant dissolution of cinnarizine tablets in a USP 2 dissolution apparatus

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Dissolution tips

Two stage biorelevant dissolution

This in vitro experiment simulates the in vivo process when fasted stomach fluid (FaSSGF) containing a drug product is converted to fasted intestinal fluid (FaSSIF).

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Dissolution tips

pH reproducibility of two Stage biorelevant dissolution kit

Learn about pH of FaSSGF and FaSSIF prepared from the Two Stage Biorelevant Dissolution

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Filters for two stage dissolution testing

This post describes filters designed for two stage dissolution testing

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Single vs repeated use of filters for two stage biorelevant dissolution

This post describes best practice use of filters during two stage dissolution testing

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What is simulated intestinal fluid USP (with or without enzyme)?

This post describes simulated intestinal fluid USP (with and without enzyme)

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A comparison of USP-SIF (sp) with biorelevant FaSSIF medium

This post compares and contrasts USP SIF with FaSSIF medium

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What are Gastric fluid, simulated, TS (Test Solution) and USP-SGF (sp)?

This post explains what are Gastric fluid, simulated, TS and USP-SGF (sp).

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USP <1236>: Solubility Measurements Chapter

This post summarises USP Chapter <1236>

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What is equilibrium solubility of a drug?

This post explains equilibrium solubility of a drug substance in a test medium

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What is supersaturation of a drug substance?

This post explains supersaturation of a drug substance

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What is the difference between a drug product and a drug substance?

If you're developing an NCE (new chemical entity) or generic drug it’s helpful to understand the difference between drug substance and drug product.

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Biorelevant media

What is a High-Fat FDA meal?

A High-Fat FDA meal is a standardized meal that is orally administered along with a drug product to create fed state/condition in human clinical trials.

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Biorelevant media

How can food affect drugs in the fed stomach?

In patients with a healthy stomach, a high-fat meal can have multiple effects on the stomach and its fluids.

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Guides and Calcs

HPLC mobile phase selection for biorelevant samples

This post describes selection of mobile phase for biorelevant samples analysed by HPLC

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Guides and Calcs

HPLC column selection for analysing samples containing biorelevant medium

This post explains HPLC column selection for analysing samples containing biorelevant medium

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Guides and Calcs

What is Maximum drug concentration calculator?

Before making PS, calculate theoretical maximum drug concentration required for analysis...

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Guides and Calcs

What is Primary standard target concentration calculator?

This calculator helps you to figure out what will be the concentration of primary standard according to the amount of drug in the dosage form

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Guides and Calcs

What is Primary standard (PS) calculator?

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 known drug concentrations.

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Guides and Calcs

What is Secondary standard (SS) calculator?

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.

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Guides and Calcs

What is Highest (HD) and Lowest drug (LD) concentration standards calculator?

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.