Pharmaceutical Injection

A "Lyophilized Powder for Injection refers to a freeze-dried pharmaceutical product that is intended to be reconstituted (usually with Water for Injection or another appropriate sterile diluent) and then administered by injection (intravenous, intramuscular, subcutaneous, etc.). It™s produced by removing almost all water from the liquid formulation under low temperature and vacuum to stabilize the active drug and extend shelf life. Below is a general overview of typical specification elements that such products must meet in regulatory and quality control documents (e.g., product monographs, pharmacopeia, regulatory submissions). Specific values vary by drug type, manufacturer, and regulatory authority (e.g., CDSCO/USFDA/EMA). Typical Specification Components for Lyophilized Powder for Injection 1. Description Physical appearance: usually a white or off-white lyophilized cake or powder. Should be free of visible foreign particulate matter before reconstitution. 2. Identification Tests Chemical identity (e.g., using IR, HPLC, mass spec) to confirm the active ingredient. May include tests for specific excipients or buffers used. 3. Assay / Content Uniformity Quantity of active drug per vial must be within a specified range (e.g., 90 %“110 % of label claim, depending on monograph).