Suppose, Vit- E is one of the materials used to produce a capsule. while the capsule has other materials like Vit-B6, Vit-B12, ferrous sulfate, Calcium D pantothenate, Riboflavin, Nicotinamide, thiamine mononitrate, manganese sulfate, magnesium chloride, soybean oil, soya lecithin, bees wax etc.
During the raw material test, the QC department found Vit-E assay result is 95%. After manufacturing the capsule, is it possible that the assay of Vit-E can be changed?
Assay:
For API: It is a procedure to analyze and determine the percentage of the API because API may contains other contents like water, related substances.
For drug product: It is a procedure to analyze and determine the percentage of the drug present in the product.
The assay can be calculated by three different ways. Such as assay on as is basis, assay on dried basis and assay on anhydrous basis.
Potency:
Potency is a comparative measure of different doses of two drugs that are needed to produce the same pharmacological effect. It is also known as drug strength. Simply, Potency is the amount of drug needed to produce a certain response.
In other words, Potency refers to the concentration (EC50) or dose (ED50) of a drug required to produce 50% of that drug’s maximal effect [2]. Certainly, more the ED 50 of a drug, less the potency and Less the ED50, more the potency. Potency is a measure of the amount of drug necessary to produce an effect of a given magnitude. Ref: https://pharmaeducation.net/efficacy-vs-potency
Potency can be calculated by eliminating % impurity, heavy metal, sulfated ash, residual solvent and LOD or Water content from the targeted drug.
After manufacturing a drug product the Assay of a drug and the Assay of that drug in drug product may not be same. Because of one or more reasons such as drug drug interaction, drug excipients interactions, moisture absorption, impurity generation during manufacturing.
Furthermore tocopherol easily forms oxidaton products, so probably the contents of the manufactured product will be lower than the API.
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