#Supertab 11sd series#

For instance, when qualifying a new supplier of raw materials, it is important to ensure the data shows similarity, or a tighter control may be required for a key parameter due to unnecessary effects on a product performance characteristic. The data depends on a particular application. There is no generic right or wrong data set for all products or processes. Data generated for density, porosity, and surface area. Lot with particle size (volume distribution). Based on the internally developed specification or application of a particular company, the data could be used to reveal lot-to-lot similarity or may reveal that further controls are required to make sure that the material is suitable for a particular application. Table 1 and 2 below lists the data produced for each test given above. BET specific surface area utilizing krypton gas on the ASAP 2420 surface area analyser.Particle size distribution by laser light scattering on the Saturn DigiSizer II.Skeletal or true density by helium pycnometry on the AccuPyc 1340.Porosity by mercury intrusion porosimetry on the AutoPore IV 9500.Microcrystalline cellulose (Pharmacel 101)Īll materials were analyzed for the following characteristics:.DFE Pharma provided the following excipients: In order to replicate a raw material vendor qualification study, three lots of each material were examined.

#Supertab 11sd series#

In this study, lactose and microcrystalline cellulose were subjected to a series of tests to show the level of consistency of the materials. Supplier-to-supplier or lot-to-lot variation in these materials may possibly give rise to unnecessary issues, especially when they form the bulk of a formulation. Microcrystalline cellulose and lactose are common excipients that are used in solid oral dosage forms. By implementing these guidelines regarding active pharmaceutical ingredients (APIs) and excipients, companies can gain more insight into their materials and the extent of their effect in a formulation. The ICH Q8, Q9, and Q10 guidelines outline Quality by Design, risk analysis, design space and control strategies. In certain cases, this data may provide a better understanding about the behavior of a specific material in a given process such as blending, flow and compression, or in a final dosage form such as dissolution, disintegration and bioavailability. In addition, other tests such as porosity, density or surface area may not be reported. The specification data provided by a manufacturer relating to particle size may be broader than what is actually preferred for a specific product or process. Some of this physical testing data, such as particle size for example, is generally provided by the manufacturer. The physical characterization of pharmaceutical excipients provides data that can be predictive in nature regarding the performance of final dosage forms such as tablets, capsules and transdermals. Sponsored by Micromeritics Instrument Corporation Dec 18 2014