Drug Substance Specification.

    November 5, 2022

Drug Substance Specification.
The active drug substance is AZD4635. Students will have to develop the specifications for AZD4635.
Create you own data package to support your specifications. Propose 2 hypothetical impurities based on the compound and the synthesis. Write a report on the tests chosen for the specifications and provide justifications. Assume the MDD (maximum daily dosage) is 100 mg/day.
The paper provided describes how it is synthesized and gives some guidance on certain tests that would be critical for setting its specification.
Highly recommend listen to lectures 15 and 16 again before doing assignment 3.
1. Lecture 16 slide 11 should be the kind of tests you need to include in your specification. Note the solvents and metals you include will depend on the synthesis shown in the paper.
2. The 2 hypothetical impurities you create should make sense based on the synthesis described for AZB1656 and the structure. For example an impurity could be the structure resulting from the loss of a methyl group or a halogen. These impurities you create have to be organic compounds – NOT inorganic impurities. Include the structures of these impurities in your report.
3. When I say create your own data – provide example of a data set for the reaction similar to slide 8 and 9 in Lecture 16. PLEASE SHOW YOUR DATA IN THE REPORT. I would recommend having at least two batches of data set. You can have more if you want.
4. The paper gives some clues on certain levels of palladium or iridium you are dealing with in the reaction. This will guide the limit you should set.
5. Assume the MDD (maximum daily dosage) is 100 mg/day. You will need to using this MDD to calculate (please show all calculations) your maximum allowable concentration of solvents, metals, and limits for impurities.
6. Provide explanations to back up why you chose a certain limit.
7. You need to provide a table of the specifications you create for the drug substance (active drug) similar to what is shown page 11 in Lecture 16.
8. You will need to make sure the following information is included to receive full marks:
Tabulated Format showing Specification Tests; Specification Limits; Batch Data
Organic Impurities; Elemental Impurities; Residual Solvents
Calculations to justify the limits (using appropriate ICH guidelines and MDD of your choosing)
Justification of the specifications you have chosen
Structure Content, Format and References
This assignment must be typed and submitted electronically in MS Word (.docx or .pdf) format. The file must be named in the following format: Lastname_Assignment4. Submit your completed document to Assignment 4, listed on the Modules and Assignments pages, as a file attachment.
Example for guidance: Lecture 15 explains how for MDD that 2 g/day identification and reporting threshold will be 0.05% and 0.03% respectively.
Qualification threshold you have to calculate. Below is an example for an MDD chosen as 800 mg/day. Note: calculations and limits will change depending on the MDD chosen.
(1.0 mg/day/800 mg/day) *100 = 0.125 (rounded up to 0.13% sometimes).
This means any impurity that shows up >0.13% then it has to be qualified through an appropriate toxicology study. In that case, the level of that impurity in the toxicology batch ends up being the limit allowed for that impurity if it is above the qualification threshold.

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