It is the ability of the analytical method to relate the obtained results over a specific given range through mathematical equations or proportional to the concentration of the analyte in the sample in that specific range. Accordingly, Linearity is an important tool to assure that the response of the Area Under Concentration will be later translated into the correct percentage of that analyte in the sample
The linearity can be achieved by transforming from for example log, square root or reciprocal values of the AUC in order to be correlated to the correct assay percentage. The principle is to have a model (in other words equation) that can be applied over the desired range
The recommended Linearity Range to be covered is 80% – 120%, in practice however, the covered range is usually 50% - 150%, this is needed to include the worst case scenario and other evaluation of the behaviour of tablets and capsules during the in process controls for example (e.g., dissolution testing, where at certain point of the dissolution the full release is not achieved yet and only say 60% is in the media, therefore to create reliable dissolution profile the assay methods that covers the lower ranges are favoured)
The evaluation of the linearity is done using calibration curve and calculating its regression line and R2, both parameters should be submitted as a conclusion of the Linearity and Range testing
5. Detection Limit:
Identified as the lowest amount of analyte in a sample which can be detected by the method but not necessarily quantified as an exact value.
The limit of detection (LOD) is the degree at which the measured result is bigger than the uncertainty associated with it (in the HPLC system the peak can be distinguished from the backgroun...
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...e, the British Pharmacopeia Finished Drug Product method of analysis in the monograph was taken as granted without being checked for its appropriateness, in this situation Verification should have been carried to check at least the Accuracy, Precision and Specificity of the BP method for the finished product.
According to the findings of the performed full method validation, the specificity old method (BP one) was not specific, which means an overlap of the API peak with another component in the sample (could be excipient or degradation product) resulted in over estimation of the API content and therefore always obtaining high assay results.
The 5 rejected batches could have been saved as specificity is one of the required APC to be verified if verification was performed, in the early beginning before approving the BP method and applying it for the routine testing.
The quicker the tablets will dissolve because there will be more water. particles to collide with. So the rate increases. * If the amount of tablets being used is increased for the same amount of water, i.e. as concentration increases, rate will increase. increase as well because there will be more collisions between particles.
amounts and how to analyze the specimine using gel electrophoresis. The samples of DNA were
The analysis is therefore one of the most effective methods of ensuring that each drug being prescribed to patients is safe. It also ensures that all drug components are understood in terms of their structure and chemical behavior. This understanding is very important in the manufacture of drugs and other pharmaceutical products.
Investigating the Effect of Concentration on the Rate of Diffusion Aim: To find out if concentration affects the rate of diffusion. Prediction: I predict that the higher the concentration of acid the faster the reaction will be. Hypothesis: Diffusion is the spreading out of a gas or liquid from an area of low concentration to another area where it has a lower concentration until the overall concentrations are balanced. The Hydrochloric acid (HCl) diffuses into the gelatine cube of which contains Sodium Hydroxide (NaOH), which is an alkali. When the Hydrochloric acid combines with the Sodium Hydroxide they form salt and water, which is neutral therefore turning the pink cube to clear.
Size and stability: Liquid formulation can be bulky, difficult to transport and store.1 During storage under the stated conditions, it’s necessary that oral solutions are not subject to precipitation, fast sedimentation, caking or formation of lump.2 They have poor stability compare to solid dosage form formulation due to hydrolysis.1 Therefore, it’s important to optimize the active ingredient stability in liquid formulation including those prepared from powder or granules.2
Random and systematic errors are both factors that can affect the reliability and accuracy of the results respectively. As all the graphs contained outliers, and hence, scatter, this indicates that random errors were present. Such errors may result from the inconsistent masses of the Alka Seltzer tablets. As these tablets were cut manually with a knife, it is unlikely that the mass of each half of an Alka Seltzer tablet would be the same. Thus, when using the tablets to react with HCl, the true number of tablets reacting would have not been the same as the number denoted for the trial, and with each repeated trial for the same number of tablets reacting, the reacting mass and ratio would have not been inconsistent. Consequently, the
Another thing that must be kept constant is who much of the Alka-Seltzer tablet you use and what the surface area is. This has to be kept constant since maybe the crushed Alka-Seltzer tablet will dissolve faster because of its surface area, if you use different surface area your data will then again be
this is called toxicological or other product safety estimate. And some tests are used for a assort...
In this experiment there were eight different equations used and they were, molecular equation, total ionic equation, net ionic equation, calculating the number of moles, calculating the theoretical yield and limiting reagent, calculating the mass of〖PbCrO〗_4, calculating actual yield, calculating percent yield (Lab Guide pg.83-85).
As we discussed above that pharmacokinetic and pharmacodynamics can be seen as two sides of the same coin in order to gain better understanding of their efficacy and safety profiles.” Generally it is possible to make fairly robust predictions of the pharmacokinetic profile in man using in vitro systems and preclinical pharmacokinetic studies. A previously published survey on the causes of failure in drug development indicated that inappropriate pharmacokinetics were a major cause such as; factors as low bioavailability due to high extraction or poor absorption characteristics, short elimination half-life leading to short duration of action and excessive variability due to genetic or environmental factors. This observation has led to an increased emphasis on pharmacokinetic input to the drug discovery process throughout the pharmaceutical industry. However, it is important to realise that this may only permit the rejection of compounds to b...
Analysis of Aspirin Tablets Aim --- To discover the percentage of acetylsalicylic acid in a sample of aspirin tablets. ----------------------------------------------------------------- In order to do this, the amount of moles that react with the sodium hydroxide must be known. This is achieved by using the method of back titration.
When test results don’t have accuracy, additional testing may be needed to authenticate the results.
The working begins with an auto-sampler which picks up a definite amount of sample as programmed from the defined tube and passes in to the pump wherein it is mixed with the mobile phase in definite proportion. This is followed by entry of the mixture into the column under high pressure which aids in separation. The individual analytes in the mixture will interact with the stationary phase and finally be eluted out at a definite retention time. The retention time of each eluting component is recorded and based on this data the output is displayed in the graphical format. Peaks are seen on the graph and each peak corresponds to a particular component in the mixture, while the area under the curve of the peak denotes the concentration of the analyte. The higher the number of peaks, more is the number of analytes present in the
The distance where by a search scanner can discover something different first from its surroundings but not yet identify it.
Simple linear regression is a model with a single regressor x that has a relationship with a response y that is a straight line. This simple linear regression model can be expressed as