Drug content refers to the amount of principal components contained in a drug. Content is an important index to evaluate drug quality and a necessary content of drug quality standards.
For generic drug content analysis, pharmacopeia methods or API detection methods should be tried first. When pharmacopoeia methods or API testing methods are not suitable, content analysis methods need to be developed and optimized. Methods for determining drug content should be developed based on drug characteristics, dosage forms and prescription technology. The detection time of the content method should not be too long to meet the requirements of prescription screening.
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We provide our customers with the development and validation of generic drug content analysis methods to help manufacturers obtain accurate, specific and durable methods as quickly as possible. We comprehensively investigate the characteristics and processes of self-developed generic drugs, and change the content analysis methods of pharmacopoeia that are not applicable.
According to the characteristics of the drug, analytical methods for content analysis mainly include volumetric analysis (titration), spectrophotometry and chromatography.
Volumetric analysis
Volumetric analysis (also called titration) is to add titration droplets of a known concentration to the drug solution until the reference substance in the titration reacts completely with the drug under test. Then, according to the concentration of titrant and the volume consumed, the content of the measured drug is calculated according to the stoichiometric relationship.
Volumetric analysis is simple, accurate and durable, but it lacks specificity and is mainly suitable for the analysis of samples with high principal component content.
UV-Vis spectrophotometry
UV-Vis spectrophotometry is used to determine the absorbance of substances in the wavelength range of 190 ~ 800nm, and can be used for the quantitative analysis of drugs. Within a certain concentration range, the amount absorbed by the substance is proportional to the concentration of the substance and the thickness of the liquid layer, and the concentration of the component can be calculated according to Lamberbier's law, and then the content is obtained.
UV-Vis spectrophotometry is easy to operate, rapid, high sensitivity, but less specific, which is mainly suitable for the analysis of samples with high sensitivity and large sample sizes.
Chromatographic analysis
Chromatographic analysis is a method of selectively analyzing the measured components after separating each component from the mixture according to the difference in the chromatographic behavior of the separated substances in the mixture. Chromatographic analysis has high sensitivity, high specificity and excellent accuracy, but its results need to be calculated by reference.
For analyzing pharmaceutical preparations, chromatography is generally preferred. In the case that the relevant substances and auxiliary materials do not interfere, UV-Vis spectrophotometry or volumetric analysis can also be selected. For compound preparations, chromatography is the preferred method.
Validation of the Methods
For the content analysis methods of generic drugs prescribed in the quality standard, it is generally necessary to conduct method validation (pre-validation) before formal validation. Different principles of measurement methods have different verification requirements.
- Volumetric analysis needs to confirm the precision, accuracy, basis for determination of titration end points and durability of the analysis method.
- UV-Vis spectrophotometry needs to confirm the precision, accuracy, linear range, durability and sensitivity of the analysis method.
- Chromatographic analysis needs to confirm the precision, accuracy, specificity, linear range, durability, and sensitivity of the analysis method.
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