Comprehensive Stability Study Testing

Scientech works with its clients to develop comprehensive stability study protocols for drug products, OTC drugs, APIs, and other products.

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Comprehensive Stability Studies: Ensuring Potency, Purity, and Shelf Life of Your Products.

These protocols include the Assay/potency determination, categorization of impurities, degradants, and chemical changes, like dissolution profiles studies, disintegration, viscosities, and deformation of topical gels and creams.

Summary of Scientech’s Stability Study Services

Storage at all ICH Conditions
Protocol Design and Program Management
Stability Testing for APIs, Raw Materials, and Formulated Products
Support for Accelerated Stability
Development & Validation of Stability Indicating Methods
Temperature Cycling, Freeze-Thaw and Shipping Studies
Tailored Reporting (Timepoint and Final Reports)
Forced Degradation Testing with Degradation Product Identification & Quantification
Real-Time Stability Testing
Accelerated Stability Testing

Scientech can conduct Stability Studies in ambient, intermediate, accelerated, and long-term storage conditions. Scientech cGMP storage chambers support client’s determination of expiration dates for their products.