Custom Field for API in Label Claim as % and mg/mL

lczenith

Question 1: how create a CF for API in Label Claim as % and mg/mL?

Question 2: how calculate de amount in % of the Control standard according to the follow sequence, I mean recovery when compare with standard?

 

API (µg/mL) = (Asmp / Astd) * Cstd * (Wstd * P * Dstd * M1) / (100 * M2)

 

Sample Explanation of Variables:

• Asmp: API area obtained with each sample injection as label
• Astd: API average areas obtained with standard solution
• d: Density of the sample (g/mL) 1.20 g/mL
• Dsmp: sample dilution (mL) 20 mL
• Wsmp: mass weighted (g) 1.0 g

Content of API: 1.5 mg/mL.

 

Standard Explanation of Variables:

Note: the standard informations were included in the “components”

• Cstd: API concentration in standard solution (mg/mL)
• Wstd: API standard weighted mass for standard solution (mg/mL) (Preparation: 30 mg into 50 mL and 1 mL to 10 mL. final concentration 0.06 mg/mL)
• P: API standard potency (%) (99.9 %)

 

 

Sample name	Injection	Sample Type	Sample weight	Dilution	Density	Label Claim
Standard	1	Standard		500
Standard	2	Standard		500
Standard	3	Standard		500
Control Standard	1	Control		500
Control Standard	2	Control		500
Sample 1	1	Unknow	1	20	1.2	1.5
Sample 1	2	Unknow	1	20	1.2	1.5
Sample 2	1	Unknow	1	20	1.2	1.5
Sample 2	2	Unknow	1	20	1.2	1.5
Control Standard	3	Control		500

 Thank you.