Gamma sterilization of pharmaceuticals - A review of the irradiation of excipients, active pharmaceutical ingredients, and final drug product formulations

PDA Journal of Pharmaceutical Science and Technology

Volumn 68, Issue 2, 2014, Pages 113-137

  Hasanain, Fatima ^a   Guenther, Katharina ^a   Mullett, Wayne M ^a   Craven, Emily ^a  

^a MDS Inc   (Canada)

Author keywords

API; Excipients; Gamma; Irradiation; Polymers; Review; Sterilization; Validation

Indexed keywords

CEFOTAXIME; CEFRADINE; COPOLYMER; EXCIPIENT; FREE RADICAL; GLUTARALDEHYDE; MANNITOL; NICOTINAMIDE; OXYGEN; POLYANHYDRIDE; POLYMER; POLYVINYL ALCOHOL; RITODRINE; DRUG; DRUG CARRIER;

CARBON NUCLEAR MAGNETIC RESONANCE; CHEMICAL COMPOSITION; CHEMICAL STRUCTURE; CROSS LINKING; DECISION TREE; DIFFERENTIAL SCANNING CALORIMETRY; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG MANUFACTURE; ELECTRON SPIN RESONANCE; GAMMA IRRADIATION; GAMMA RADIATION; GAMMA STERILIZATION; GEL PERMEATION CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HYDROGEL; HYDROGEN EVOLUTION; INFRARED SPECTROSCOPY; MOLECULAR WEIGHT; NONHUMAN; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; PHARMACEUTICS; PRACTICE GUIDELINE; PROTON NUCLEAR MAGNETIC RESONANCE; PSEUDOMONAS AERUGINOSA; RADIATION DOSE; RADIATION STERILIZATION; REVIEW; STAPHYLOCOCCUS AUREUS; STORAGE; THIN LAYER CHROMATOGRAPHY; ULTRAVIOLET SPECTROSCOPY; VISCOSITY; CHEMISTRY; DRUG CONTAMINATION; DRUG INDUSTRY; DRUG STABILITY; HUMAN; INSTRUMENT STERILIZATION; PATIENT SAFETY; PREVENTION AND CONTROL; PROCEDURES; PRODUCT SAFETY; QUALITY CONTROL; RADIATION RESPONSE; STANDARDS;

CONSUMER PRODUCT SAFETY; DRUG CARRIERS; DRUG COMPOUNDING; DRUG CONTAMINATION; DRUG INDUSTRY; DRUG STABILITY; EXCIPIENTS; GAMMA RAYS; HUMANS; PATIENT SAFETY; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; STERILIZATION;

EID: 84899684490     PISSN: 10797440     EISSN: 19482124     Source Type: Journal    
DOI: 10.5731/pdajpst.2014.00955     Document Type: Review

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