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Potency is the purity of the compound ;this states % available of the main component without water and residual solvents Assay is defined as Potency plus water and residual solvents and other remaining fractions please note assay can also be expressed as as is basis or dry basis Assay and Potency are same if assay is exprtessed as as is basis please note Potency word is mainly used for Antibiotics and bilogicals courtsey ; CDER , USFDA ; Dr.Uttam Krishna
Potency refers to the strength or effectiveness of a drug, typically measured in terms of its ability to produce a specific effect at a given dose. Assay, on the other hand, is a quantitative measurement of the drug's concentration or purity in a sample, often used to confirm its identity and quality. In essence, potency focuses on efficacy, while assay focuses on measuring the quantity or quality of a drug substance.
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Difference between assay as is basis and dried basis?
Assay on 'as is' basis refers to the composition of a substance including its water content, while assay on 'dried' basis refers to the composition of a substance after removing the water content. Comparing these two types of assays can help in understanding the true chemical composition of a substance excluding the influence of water content.
Why assay limit is set as 98 to 102 percent in pharma api?
The assay limit for pharmaceutical APIs is set as 98-102% to ensure that the product is of high quality and meets the purity requirements. This range accounts for variability in manufacturing processes and analytical methods, allowing for slight fluctuations while still maintaining the efficacy and safety of the drug. It is important for pharmaceutical products to have the specified potency to ensure consistent therapeutic effects for patients.
What is the difference between Berberine and Berberine HCL?
Berberine is a compound found in plants while Berberine HCL is a specific form of berberine that is combined with hydrochloric acid to increase its potency and bioavailability. Berberine HCL is often used in supplements for better absorption in the body.
How do you calculate Assay of Ceftriaxone sodium BP on anhydrous basis?
To calculate the assay of Ceftriaxone sodium BP on an anhydrous basis, you first need to determine the molecular weight of Ceftriaxone sodium. Next, you would divide the weight of the anhydrous Ceftriaxone sodium by the total weight of the sample and multiply by 100 to get the percentage on an anhydrous basis. This calculation helps ensure accurate dosing and purity of the compound.
Can you please use the word potency in a sentence?
The potency of the medicine was evident in how quickly it relieved her pain.
How do you assay thrombin potency?
You can assay thrombin potency by measuring its ability to convert fibrinogen to fibrin, typically using a chromogenic or clot-based assay. The results are compared to a standard curve to determine the potency of the thrombin sample.
What is the formula for calculating assay and potency?
Assay is typically calculated as the percentage of the active ingredient present in a sample compared to the total sample weight. Potency is a measure of the strength or concentration of the active ingredient in a sample relative to a standard reference. The formula for assay and potency calculations may vary depending on the specific assay method and the properties of the substance being analyzed.
What is a four point biological assay?
Four point assay refers to an estimate of the potency of a drug by measuring the response it produces in a biological it produces i n abiological preparation
Is pyrogen test an antimicrobial assay?
No. Pyrogen testing is a process used by drug manufacturers to see if a vaccine or drug has toxins that might cause a fever.An antibiotic assay is used to determine the potency of the antibiotic.
What is the difference between assay on as is basis and assay on anhydrous basis?
Assay on as is basis refers to the percentage of a substance in its current state, including any impurities or water content present. Assay on anhydrous basis, on the other hand, refers to the percentage of a substance calculated without including any water content present. This difference is important when comparing the purity of substances or calculating accurate concentrations in chemical analysis.
Difference between assay as is basis and dried basis?
Assay on 'as is' basis refers to the composition of a substance including its water content, while assay on 'dried' basis refers to the composition of a substance after removing the water content. Comparing these two types of assays can help in understanding the true chemical composition of a substance excluding the influence of water content.
What is the difference between assay and analysis?
Assay is the quantitative determination of the amount of a component in a sample. Purity is the determination of the impurities in the sample. It can be quantitative, semi-quantitative or qualitative. For example : if you dissolve 4 grams of compound A (with no impurities in it) in 6 grams of water, you get a solution of compound A with 100% purity and 40% assay. From the ICH Guideline Q2A (Validation of Analytical methods) : "- Testing for impurities can be either a quantitative test or a limit test for the impurity in a sample. Either test is intended to accurately reflect the purity characteristics of the sample. [...] - Assay procedures are intended to measure the analyte present in a given sample. In the context of this document, the assay represents a quantitative measurement of the major component(s) in the drug substance."
What is an assay pound?
An assay pound is a small standard weight used in assaying bullion, which varies between assayers, but is generally around half a gram.
Fiducial Limits in Microbiological Assay?
Fiducial limits in a microbiological assay represent the confidence interval within which the true value of an analyte is expected to fall. They are calculated based on the variability of the assay and provide a range in which the true value is likely to lie with a certain level of confidence. Fiducial limits are useful for assessing the precision and accuracy of an assay.
What is the difference of grated allspice to whole allspice.?
The grated allspice will lose it's potency more rapidly.
What is protein assay?
Protein assay is the determination of concentration or total level of protein in a solution.There are various protein assays employed like bradford assay and lowry assay
What is difference between end point and kinetic assay in biochemistry?
In biochemistry, an endpoint assay measures the final amount of a product formed or substrate remaining after a reaction has stopped, providing a single data point. A kinetic assay, on the other hand, measures the rate of a reaction by recording multiple data points over time. Kinetic assays provide additional information about reaction mechanisms, enzyme activity, and inhibitor kinetics compared to endpoint assays.
