difference between chromatographic purity and related substances

1. What is related substances and chromatographic purity?
2. What is difference between assay and related substances?
3. What is the difference between related substance and impurity?
4. What is related substances in pharmaceuticals?
5. What is chromatographic purity?
6. What is RRF HPLC?
7. Why assay is more than 100?
8. What does Assay mean?
9. Why we do Assay by HPLC?
10. How many types of impurities are there?
11. What are the different types of impurities?
12. What are the sources of impurities in pharmaceutical substances?

What is related substances and chromatographic purity?

Chromatographic purity demonstarte the actual amount of the. substance present with unknown impurities. Chromatographic Purity means Unspecified impurities by area.

What is difference between assay and related substances?

The main difference between assay and purity is that an assay is the determination of one of the main component in a sample whereas purity is the determination of impurities in a sample. ... Assay and purity are two types of measurements used to determine the components of a sample.

What is the difference between related substance and impurity?

Impurity: something that is there as a result of the chemistry involved in making the product. Impurities should generally be a constant over time - some batch to batch variation will exist. Related substance: something that is there as a result of the stability (or lack thereof) of the product.

What is related substances in pharmaceuticals?

Related substances are structurally related to a drug substance. These substances may be identified or unidentified degradation products or impurities arising from a manufacturing process or during storage of a material. ... These substances may be introduced during manufacturing or handling procedures.

What is chromatographic purity?

Simply, chromatographic purity is a test ( usually TLC or HPLC ) where the sample is compared to some standards, and the spots/peaks of any impurities detected must not exceed the prescribed limits for size and number. ... The monographs may define the expected retention properties, and the limits for these impurities.

What is RRF HPLC?

Relative Response Factor (RRF) is an analytical parameter used in chromatographic procedures to control impurities/degradants in drug substance and drug product. RRF is used to correct the difference in detector response of impurities with analyte peak. RRF is established by slope method with linear range of solutions.

Why assay is more than 100?

There is a simple reason to have the purity greater than 100% for this compound. If the substance was exposed to a dry environment for several hours, a small amount of the water of hydration could be lost, causing the calculation to have a higher purity.

What does Assay mean?

An assay is a process of analyzing a substance to determine its composition or quality. The term is often used in the mining industry to refer to tests of ore or minerals. The term assay is also used in the environmental, chemical and pharmaceutical industries.

Why we do Assay by HPLC?

Assays based on HPLC are very commonly used to measure the quality of drugs and, according to ICH, certain parameters must be checked to validate the analytical method: linearity, specificity, accuracy, precision (inter and intraday), limit of detection (LOD), limit of quantitation (LOQ) and robustness (ICH-Q2B, 2005; ...

How many types of impurities are there?

Impurities, present in various textiles, are of two types: natural and added. Natural fibres like cotton, wool, silk, etc., are grown under natural conditions, during which these fibres acquire natural impurities like dirt, dust, minerals, fatty matters, etc.

What are the different types of impurities?

The three different types of impurities in pharmaceuticals include organic, inorganic, and residual solvents. Most of these impurities occur due to manufacturing processes, degradation, storage conditions, excipients, or contamination.

What are the sources of impurities in pharmaceutical substances?

The various sources of impurity in pharmaceutical products are — reagents, heavy metals, ligands, catalysts, other materials like filter aids, charcoal, and the like, degraded end products obtained during \ after manufacturing of bulk drugs from hydrolysis, photolytic cleavage, oxidative degradation, decarboxylation, ...