It can be done through NIR Analysis:
1. Identity of packaged clinical supplies verification :
It is best opted for the verification of the packaged clinical supplies identification due to its speed, its nature of non destruction property and its low cost. This method is developed recently to distinguish between pharmaceutically active and inactive substance. NIR is used for identification of the four forms in the blister rapidly and nondestructively.
It is mainly focused as it is used to creating and validation of spectra of one time use library which are prepared for double-blind clinical trails.
In recent developments a new invention is made which can used to do both i.e. generation and validation of the library simultaneously.
2. Identification of raw materials:
It is the major and most important use of NIR in the pharmaceutical analysis. Many agencies which are regulated have made compulsory that before the materials are sent for mixing, compounding and production they should be verified with the help of NIR rather than with statistical sampling. At least the minimum requirements as per European pharmacopoeia 1997, should be satisfied if NIR is used. This method is almost similar to that of the identification of the packaged clinical supplies. If any spectral variation is seen it indicates that there may be any variations which have to be faced by the raw materials in the future. Here the library can be updated with the any new raw materials, phased out materials which do not persists any more in the manufacturing process or materials whose physical properties are changed. So library here is said to be dynamic.
Here the compound which is unknown is selected i.e. accepted or rejected based on its position where it is laying i.e. how close to its spectrum of a known compound and it should be in accepted variations.
3. Blend homogeneity:
Homogeneity of any raw materials in a pharmaceutical study can be done by spectral matching, visual matching or principal component analysis at discrete time intervals of the spectra. By other process it can be done by using NIR spectroscopy at line during the process of production to control the quality of a product. In order to obtain the assess the extent to which components that were blended in a v-blender the values of the NIR spectra obtained after different mixing intervals are used. Fiber-optic probe at high, middle and low are used to collect the NIR reflectance spectra. The relative standard deviation (RSD) of the NIR results at each interval and at a wavelength which is specific to active component is calculated. HPLC analysis of the blend is also performed along with this.
The RSD values of the NIR and RSD values of the HPLC are plotted versus the minutes mixed in order to prove that NIR method is compared to the results obtained by HPLC assay. Thus this experiment helps in showing the feasibility of using NIR to determine the both active pharmaceutical ingredient and excipients blend homogeneity simultaneously in real time which ensures the optimum content uniformity in the process of capsule filling or compression.
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1). Hand book of modern pharmaceutical analysis edited by Satinder Ahuja and Stephen skypinski [pg.no: 252-256]
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