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level: NEW DRUG SUBSTANCE / PRODUCT

Questions and Answers List

level questions: NEW DRUG SUBSTANCE / PRODUCT

Question	Answer
The following tests and acceptance criteria are considered generally applicable to all new drug substances.	1 Description 2 Identification 3 Assay 4 Impurities
a qualitative statement about the state (e.g. solid, liquid) and color of the new drug substance.	Description
If the new drug substance is a salt, identification testing should be __ for individual ions	specific
In identification, use of two chromatographic procedures, where the separation is based on different principles or a combination of tests into a single procedure, such as HPLC/UV diode array, HPLC/MS, or GC/MS is generally acceptable. TRUE OR FALSE	TRUE
New drug substances which are __ may also need specific identification testing or performance of a CHIRAL ASSAY.	optically active
A specific, STABILITY-INDICATING procedure should be included to determine the content of the new drug substance.	Assay
Organic and inorganic impurities and residual solvents are included in this category.	Impurities
IN Impurities: SHOULD BE STATED FOR INDIVIDUAL AND SPECIFIED DEGRADATION PRODUCTS, which may include both identified and unidentified degradation products as appropriate, and total degradation products.	Acceptance limits
NOT included in the total impurities limit.	Process impurities
These are properties such as pH of an aqueous solution, melting point / range, and refractive index. The tests performed in this category should be determined by the physical nature of the new drug substance and by its intended use.	Physicochemical properties
different crystalline forms which differ in their physical properties. include solvation or hydration products (also known as pseudopolymorphs) and amorphous forms.	Polymorphic forms:
are commonly used to determine whether multiple forms exist.	Physicochemical measurements and techniques
New Drug Substances Specification Categories	1 Physicochemical properties: 2 Particle size 3 Polymorphic forms 4 Tests for chiral new drug substances:
IN Polymorphic forms, __ can generally be used to monitor product performance, and __ should only be used as a test and acceptance criterion of last resort.	surrogate test, polymorph content
Where a new drug substance is predominantly one enantiomer, the opposite enantiomer is excluded from the qualification and identification thresholds given in the ICH Guidelines on Impurities in New Drug Substances and Impurities in New Drug Products because of practical difficulties in quantifying it at those levels.	Tests for chiral new drug substances
For chiral drug substances which are developed as a single enantiomer, control of the other enantiomer should be considered in the same manner as for other impurities. TRUE OR FALSE	TRUE
For a drug substance developed as a single enantiomer, the identity test(s) should be capable of distinguishing both enantiomers and the racemic mixture. TRUE OR FALSE	TRUE
For a racemic drug substance, there are generally two situations where a stereospecific identity test is appropriate for release/acceptance testing:	1) where there is a significant possibility that the ENANTIOMER might be SUBSTITUTED for the RACEMATE 2) when there is evidence that PREFERENTIAL CRYSTALLIZATION may lead to unintentional production of a NON-RACEMIC MIXTURE