Studies of extractable and leachable components (E&L) within packaging systems and pharmaceutical container closures have become mandatory to meet the safety requirements for marketed medicines over the past two decades.
The regulatory guidance for E&L provides only general recommendations to ensure safety.
The development and analysis of E&L for inhalation, ophthalmic, and injectable drug products is challenging since studying them depends on the type of formulation and packaging material being used.
Piramal Pharma Solutions has developed analytical methods for quantification of the below potential extractables by various techniques.
- Phthalates
- Nitrosoamines
- Elements
- Volatile /Semi-volatile organic compound
- Polynuclear aromatic hydrocarbons
- Antioxidants and elastomer additives
- Fatty acids
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