This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, sections …
This is the same data as in the example files here in xml and in json, presented for easier viewing. Hovering on words below will show the corresponding sections of the underlying data.
Chemical Name / Descriptor | Structure | Molecular weight (g/mole) | Category | Impurity Characterization Method Summary | Levels Observed in the API |
---|---|---|---|---|---|
R-enantiomer of stelbatalol | 295.80 | Chiral Impurity | Enantiomeric purity by LC; Mass spectrometry | ND | |
Impurity 1 | 344.4 | Process impurity | Organic impurities by HPLC | Range: ND-0.2% | |
Impurity 2 | 459.58 | Process impurity | Organic impurities by LC | Range: ND–0.3% | |
β-naphthol | 144.173 | Starting material, forced degradation product | Organic impurities by HPLC; Chromatographic retention | Observed only during stress studies | |
1-(Ethylamino)-3-(2-naphthyloxy)-2-propanol | 245.32 | Process intermediate, forced degradation product | Impurity content by LC-MS; UV spectroscopy; NMR spectroscopy | Observed only during stress studies |
Chemical Name / Descriptor | Structure | Origin in Process |
Bacterial Mutagenicity Predictions or Knowledge |
Comments | ||
---|---|---|---|---|---|---|
Rule-Based (Q)SAR | Statistical (Q)SAR | ICH M7 Classification | ||||
R-enantiomer of stelbatalol | Enantiomer of API SM | Negative | Negative | Class 5 | Treated as non-mutagenic due to lack of alerting structure | |
Impurity 1 | Step 1a Process Impurity | Negative | Negative | Class 5 | Treated as non-mutagenic due to lack of alerting structure | |
Impurity 2 | Step 1a Process Impurity | Negative | Negative | Class 5 | Treated as non-mutagenic due to lack of alerting structure | |
β-naphthol | API Starting Material | Negative | Negative | Class 5 | Treated as non-mutagenic due to lack of alerting structure | |
1-(Ethylamino)-3-(2-naphthyloxy)-2-propanol | API Process Intermediate | Positive | Positive | Class 2 | Control at or below qualification threshold |