Differbetween
A "related substance" is a pharmaceutical industry term for contaminants which are structurally similar to the active drug (the are chemically "related"). In practice, the term is often applied to impurities and contaminants in a drug whether or not they are chemically related. The importance should be self-evident.
- What are related substances?
- What is difference between assay and related substances?
- What is the difference between chromatographic purity and related substances?
- What is the difference between related substances and organic impurities?
- What assay means?
- How many types of impurities are there?
- Why assay is more than 100?
- Why we do Assay by HPLC?
- How many types of HPLC are there?
- What are the sources of impurities in pharmaceutical substances?
- How do you calculate impurities?
- What is impurity profile of a drug?
What are related substances?
(1) Any component of the new drug substance which is not the chemical entity defined as the new drug substance. (2) Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. CLASSIFICATION OF IMPURITIES.
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 chromatographic purity and related substances?
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. ... Note that another category "process impurities" specifically excludes related substances and water.
What is the difference between related substances and organic impurities?
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 assay means?
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.
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.
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.
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 HPLC are there?
HPLC analyses fall into four different categories: (1) reverse phase chromatography where the stationary phase is hydrophobic (C18-modified silica), (2) normal phase chromatography where the stationary phase is hydrophilic (silica), (3) hydrophilic interaction chromatography, a hybrid of techniques 1 and 2, and (4) ion ...
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, ...
How do you calculate impurities?
We have developed / validated a method where impurities are calculated by the known formula: %imp= (Atest/Aref)* limit. Comparison of the % percentage for an unknown imp.
What is impurity profile of a drug?
Impurity profiling is the common name of a group of analytical activities, the aim of which is the detection, identification/structure elucidation and quantitative determination of organic and inorganic impurities, as well as residual. solvents in bulk drugs and pharmaceutical formulations.
