Calculating the Sample Concentration
The sample concentration will be calculated against a reference standard of known concentration. The result in % label claim will be compared to acceptable ranges stated in the dissolution method or monograph.
The following calculation provides results in % label claim (%LC).
Move the cursor over the blue elements of the calculation for a description.
Once analyzed, dissolution samples are calculated to determine the amount dissolved (mg) and/or the percent of the labeled amount of active drug substance dissolved in solution.
- Dissolution Results Percent Label Claim (%LC)
- =
- x
- x
- x
- 100
Sample response, UV Absorbance or HPLC integrated value
Standard response, UV Absorbance
or HPLC integrated value
Accurate weight of the
reference standard in mg
The volume of diluent in which the
standard was dissolved. The standard
may require additional dilution [mL/mL].
Dissolution Sample volume,
typically 500 mL or 900 mL
The amount of active drug (mg)
contained in each dosage unit