The data contained within the Drug Master Files for ZEPHEX®134a and ZEPHEX® 227ea, and provided for inclusion in marketing authorisation applications covers all the requirements of the regulatory authorities.
| 3.2.P.4.6 |
NOVEL EXCIPIENTS |
| |
| 3.2.P.4.6.1 |
GENERAL INFORMATION |
| 3.2.P.4.6.1.1 |
Nomenclature |
| 3.2.P.4.6.1.1.1 |
International non-proprietary name |
| 3.2.P.4.6.1.1.2 |
Chemical name (CAS and IUPAC) |
| 3.2.P.4.6.1.1.3 |
Other names |
| 3.2.P.4.6.1.1.4 |
Code name |
| 3.2.P.4.6.1.2 |
Structure |
| 3.2.P.4.6.1.2.1 |
Structural formulae |
| 3.2.P.4.6.1.2.2 |
Molecular formulae |
| 3.2.P.4.6.1.2.3 |
Relative molecular mass |
| 3.2.P.4.6.1.2.4 |
Chirality |
| 3.2.P.4.6.1.3 |
General Properties |
| 3.2.P.4.6.1.3.1 |
Description |
| 3.2.P.4.6.1.3.2 |
Solubility |
| 3.2.P.4.6.1.3.3 |
Melting point and boiling point |
| 3.2.P.4.6.1.3.4 |
Viscosity |
| 3.2.P.4.6.1.3.5 |
Density |
| |
| 3.2.P.4.6.2 |
MANUFACTURE |
| 3.2.P.4.6.2.1 |
Manufacturer |
| 3.2.P.4.6.2.2 |
Description of Manufacturing Process and Controls |
| 3.2.P.4.6.2.2.1 |
Starting materials, reagents and solvents for manufacture |
| 3.2.P.4.6.2.2.2 |
Synthetic route |
| 3.2.P.4.6.2.2.3 |
Description of process |
| 3.2.P.4.6.2.3 |
Control of Materials |
| 3.2.P.4.6.2.3.1 |
Starting materials |
| 3.2.P.4.6.2.3.2 |
Reagents and solvents and other materials |
| 3.2.P.4.6.2.4 |
Control of Critical Steps and Intermediates |
| 3.2.P.4.6.2.5 |
Process Validation and Evaluation |
| 3.2.P.4.6.2.6 |
Manufacturing Process Development |
| |
| 3.2.P.4.6.3 |
CHARACTERISATION |
| 3.2.P.4.6.3.1 |
Elucidation of Structure and Other Characteristics |
| |
Infra-red absorption spectrum |
| 1H-NMR spectrum |
| 13C-NMR spectrum |
| 19F-NMR spectrum |
| Mass spectrum |
| 3.2.P.4.6.3.2 |
Impurities |
| 3.2.P.4.6.3.2.1 |
Potential impurities arising from synthesis/production |
| 3.2.P.4.6.3.2.2 |
Analytical test procedures for potential impurities |
| 3.2.P.4.6.3.2.3 |
Impurities found in batches of propellant |
| |
| 3.2.P.4.6.4 |
CONTROL OF EXCIPIENT |
| 3.2.P.4.6.4.1 |
Specification |
| 3.2.P.4.6.4.2 |
Analytical Procedures |
| |
Identity by infrared spectroscopy |
| Identity test by gas chromatography |
| Determination of water content |
| Acidity |
| Non-condensible gases in the vapour phase |
| Content of organic related impurities |
| Purity of propellant |
| 3.2.P.4.6.4.3 |
Validation of Analytical Procedures |
| 3.2.P.4.6.4.4 |
Batch Analysis |
| 3.2.P.4.6.4.5 |
Justification of Specification |
| |
| 3.2.P.4.6.5 |
REFERENCE STANDARDS |
| 3.2.P.4.6.5.1 |
Primary Reference Standard |
| 3.2.P.4.6.5.2 |
Authentic Working Standards |
| |
| 3.2.P.4.6.6 |
CONTAINER CLOSURE SYSTEM |
| |
| 3.2.P.4.6.7 |
STABILITY TESTS ON EXCIPIENTS |
| 3.2.P.4.6.7.1 |
Stability Summary and Discussions |
| 3.2.P.4.6.7.1.1 |
Introduction |
| 3.2.P.4.6.7.1.2 |
Containers |
| 3.2.P.4.6.7.1.3 |
Conditions of storage |
| 3.2.P.4.6.7.1.4 |
Methods employed for stability testing programme |
| 3.2.P.4.6.7.1.5 |
Stability results and discussion |
| 3.2.P.4.6.7.1.6 |
Proposed storage conditions and retest date |
| 3.2.P.4.6.7.2 |
Ongoing Stability Protocol and Commitment |
| 3.2.P.4.6.7.3 |
Stability Data |
