Analytical Development
Precision Analytical Development For Injectables
As a reliable CDMO partner, we focus on creating precise analytical methods that guarantee the quality and safety of injectable products.
At Derren, our team provides a comprehensive range of analytical services, covering everything from raw materials to finished goods, all designed to meet the highest quality standards. Driven by our commitment to patient well-being, we conduct each test with meticulous attention to detail and an unwavering dedication to precision.
Analytical Development Work Profile
Analytical method development of non pharmacopoeial methods for sterile products such as Injectable solution, Suspension, Emulsion, Lyophilized Injection, Ophthalmic solution & suspension using QBD approach on sophisticated instruments.
Analytical method validation for non pharmacopoeial methods for sterile products such as Injectable solution, Suspension, Emulsion, Lyophilized Injection, Ophthalmic solution & suspension using sophisticated instruments as per ICH guideline (Q2).
Analytical method verification for pharmacopoeial methods.
Development and validation of cleaning methods using MACO criteria
Analytical method transfer as per USP general chapter <1224>.
Impurity characterization.
Analytical support for Life cycle management as per USP general chapter <1220>.
Method equivalency.
Analytical support for pre formulation studies.
Analytical support for Dossier Development.
Analytical support for NCE Clinical phase-I/II/III,, Generics and Value Added Generics 505(b)(2).
Stability studies for development batches.
Analytical support to QC in case of queries.
Analytical support to WFI manufacturing plant.
Equipments
HPLC (Make Thermo vanquish core & Agilent, equipped with UV and PDA detector)
UV Vis spectrophotometer
Photo stability chamber
FTIR
Head space oxygen meter (HSO meter)
Potentiometric titrator
TOC analyser
pH meter