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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.

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βˆ™ 5mo ago
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Q: Why assay limit is set as 98 to 102 percent in pharma api?
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