Stablity studies
Right Stablity condition = Less MoH Queries
Email your product Stablity document requirements to dhaarmi@fidesregulatory.com / fidesraa@gmail.com - We will review your requirements and revert back to you ASAP. And will also provide quote / index on demand
Stablity studies - For formulation & API
Best Quality - Query-free - Reasonable Price
Stablity studies Protocol:
Approval page
Purpose
Test Design
Number of samples
Report content
Stablity studies Report:
Responsibility
Summary
Objective
Test Material
Composition
Packaging
Storage conditions and testing intervals
Analytical procedures
Reference standard
Results
Discussion / Conclusions
Test results in tabular form
Dosage form
Solid, Semi-solid, Liquid
Tablets (IR & Modified)
Capsules (Hard & Softgel)
Ointment / Gel
Solution & Powder for Injection
Oral liquid / Suspension / Powder
Aerosol (inhaler)
Powder
