Injectable Solution/Lyophilized Powder
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| Technical Objectives | Analytical Characterization Capabilities | Established Analytical Methods |
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Identify the critical quality attributes (CQAs), formulation composition, impurity profile and acceptance criteria, and lyophilization cycle parameters of the reference listed drug (RLD). Identify the critical quality attributes (CQAs) of key raw materials. Support formulation screening and process optimization for in-house developed products by addressing challenges such as batch-to-batch variability. Provide analytical data to support formulation and product sameness (Q1-Q2-Q3). Establish scientific evidence and objectives for in-process controls.
| Reverse-phase and normal-phase HPLC for determination of drug content and related substances, including characterization of known and unknown impurities and establishment of impurity acceptance criteria. Multiple qualitative and quantitative analytical techniques, including 1H NMR, 13C NMR, HPLC, UV spectroscopy, and HPLC-MS, for identification and quantification of formulation components.
| Quantitative analysis of metal ions and metal-containing excipients. Quantitative analysis of HPMC. Quantitative analysis of starch. Quantitative analysis of povidone. Quantitative analysis of polyvinyl acetate-povidone mixture. Quantitative analysis of lactose. Quantitative analysis of inorganic ions and inorganic ion-containing excipients. Quantitative analysis of corn starch.
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