assay as is basis

The result of assay test is termed as assay on as-is basis. The water present in a pharmaceutical use substance is not considered as an impurity and hence the result of water content test is accounted in the result of assay on as-is basis.

1. How do you calculate assay on a dry basis?
2. What is difference between potency and assay?
3. How is assay percentage calculated?
4. How is assay calculated in HPLC?
5. Can assay be more than 100?
6. How is assay calculated?
7. What is the meaning of assay on dried basis?
8. What assay means?
9. How do you calculate impurities?
10. What is assay test in HPLC?
11. How do you calculate drug content?
12. What is the percentage purity of NaOH?

How do you calculate assay on a dry basis?

of standard / conc. of sample) x potency or assay of standard. On anhydrous basis = (Assay on as is basis / 100 – moisture) x 100. On dried basis = (Assay on as is basis / 100 – LOD) x 100.

What is difference between potency and assay?

It is a procedure to analysed and determine the percentage of the drug present in the product. In the pharmaceutical industry, an assay is the main test for any drug product. As there are multiple tests for the drug product but the assay is a test that gives proper information on drug content percentage.

How is assay percentage calculated?

1. A 12.00g sample of a crystallised pharmaceutical product was found to contain 11.57g of the active drug.
2. Calculate the % purity of the sample of the drug.
3. % purity = actual amount of desired material x 100 / total amount of material.
4. % purity = 11.57 x 100 / 12 = 96.4% (to 1dp)
5. -

How is assay calculated in HPLC?

For calculating LOD and LOQ of analyte by hplc, the formula used is Factor*Standard deviation of the respone/Slope of calibration curve.

Can assay be more than 100?

If the purity of a product, especially in pharma is 99.99% and if you estimate the assay by any analytical method you may get a value exceeding 100%. This is due to the contribution of type A and type B measurement uncertainties. If you estimate the mu at 100% level you will see that it will be within +/_ X%.

How is assay calculated?

It may be of following types:

1. On as is basis = (Area of sample / Area of standard) x (conc. of standard / conc. of sample) x potency or assay of standard.
2. On anhydrous basis = (Assay on as is basis / 100 – moisture) x 100.
3. On dried basis = (Assay on as is basis / 100 – LOD) x 100.

What is the meaning of assay on dried basis?

Assay on anhydrous basis is a mathematically derived value from an experimental results of assay and water content tests. The results of assay and water content tests are determined, separately, on as-is basis. The industry-accepted formula for assay on anhydrous basis = (assay on as-is basis×100)/(100-%water).

What assay means?

An assay is a process of analyzing a substance to determine its composition or quality. The term is often used in the mining industry to refer to tests of ore or minerals. The term assay is also used in the environmental, chemical and pharmaceutical industries.

How do you calculate impurities?

We have developed / validated a method where impurities are calculated by the known formula: %imp= (Atest/Aref)* limit. Comparison of the % percentage for an unknown imp.

What is assay test in HPLC?

The assay and impurity testing of Duracor will be determined using a. separation and quantitation technique called High Performance Liquid Chromatography (HPLC). HPLC. is a separation technique that uses a flowing liquid (mobile phase) flowing past a solid (stationary phase) to separate complex mixtures.

How do you calculate drug content?

Standard solution concentration/ theoretical sample concentration x standard active ingredient activity x (if there is a transforming factor) x theoretical drug amount value. This is your calibration value. And there is scale factor too.

What is the percentage purity of NaOH?

Hence, the Percentage purity of NaOH in the sample is 80%.