ANDAs: Impurities in Drug Products.
List of the types of degradation products:
LISTING OF DEGRADATION PRODUCTS AND SETTING ACCEPTANCE CRITERIA FOR DEGRADATION PRODUCTS IN DRUG PRODUCT SPECIFICATIONS.
US FDA recommend that the drug product specification include, where applicable, a list of the following types of degradation products:
* Each specified identified degradation product
*Each specified unidentified degradation product
*Any unspecified degradation product with an acceptance criterion of not more than (≤) the figure in the identification threshold in Attachment 1, Q3B(R)
*Total degradation products
US FDA recommend that the specification for a drug product include a list of degradation products. Stability studies, chemical development studies, and routine batch analyses can be used to predict the degradation profile for the commercial product. It is important that the list of degradation products for the drug product specification be based on degradation products found in the batch(es) manufactured by the proposed commercial process.
US FDA recommend that one should include in their submission a rationale for the inclusion or exclusion of degradation products in the drug product specification. It is important that the rationale include a discussion of the degradation profiles observed in stability studies and any other batch(es) manufactured in support of the application (ANDA).
Individual degradation products with specific acceptance criteria that are included in the specification for the drug product are referred to as “specified degradation products” in this guidance. Specified degradation products can be identified or unidentified.
US FDA recommend that specified identified degradation products be included in the list of degradation products along with specified unidentified degradation products that are estimated to be present at a level greater than the identification threshold given in Q3B(R). For degradation products known to be unusually potent or to produce toxic or unexpected pharmacological effects, we recommend that the quantitation and/or detection limit of the analytical procedures correspond to the level at which the degradation products are expected to be controlled.
For unidentified degradation products to be listed in the drug product specification, we recommend that you clearly state the procedure used and assumptions made in establishing the level of the degradation product. It is important that specified unidentified degradation products be referred to by an appropriate qualitative analytical descriptive label (e.g., unidentified A, unidentified with relative retention of 0.9). US FDA recommend that you also include general acceptance criteria of not more than the identification threshold for any unspecified degradation product and acceptance criteria for total degradation products.
1.ANDAs: Impurities in Drug Products
2.ANDAs: Impurities in Drug Products: Setting Acceptance Criteria for Degradation Products
3.ANDAs: Impurities in Drug Products: Qualification of Degradation Products
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