Analytical Development

At Seven Star Pharmaceutical Services, we offer comprehensive analytical development services, focusing on method development, optimization, and validation to support pharmaceutical research and development. Our expertise spans HPLC-based methods and other analytical techniques, ensuring precise and reliable analytical solutions.

Assay Development and Validation

Assay Method Development

Diluent selection
Sample preparation and extraction procedure selection
Column selection and chromatography optimization
Development of methods for content uniformity, blend uniformity, and blend assay
Partial validation for method assessment
Method development report preparation

Assay Method Validation

Execution of analytical method validation as per protocol
Validation report preparation

Related Substances Development and Validation

Related Substances Method Development

Selection of diluent and extraction procedures
Column selection and chromatography optimization
Forced degradation studies to identify degradation pathways
Separation of unknown peaks and mass balance establishment
Limit of Detection (LOD) and Limit of Quantification (LOQ) determination
Establishment of Relative Response Factor (RRF) or Response Factor (RF)
Partial validation and method development report preparation

Related Substances Method Validation

Execution of method validation as per protocol
Validation report preparation

Dissolution Method Development and Validation

Dissolution Method Development

Solubility studies
Support for discriminating media selection
Apparatus selection
Sink condition establishment (referencing saturation solubility studies)
Standard concentration and column selection
Chromatography optimization
Method development report preparation

Dissolution QbD Trials

Support for Quality by Design (QbD) trials
Process Development Report (PDR) data generation
Report preparation

Dissolution Method Validation

Analytical method validation as per protocol
Validation report preparation

Intrinsic Dissolution Studies

Evaluation of API dissolution patterns across different sources
Identification of precipitation or polymorphic transformations (parachute effect)

Cleaning Method Development

Development of cleaning methods based on Maximum Allowable Carryover (MACO) values for various surfaces (stainless steel, glass, acrylic, Teflon, silicone rubber, Hypalon, etc.)
Partial validation covering precision, recovery (swab and rinse), specificity, linearity, filter study (if required), LOD/LOQ establishment, and solution stability
Method development report preparation

Solubility Studies

Determination of drug solubility in different buffer media (e.g., water, 0.1N HCl, pH 4.5 acetate buffer, pH 6.8 phosphate buffer)
Establishment of sink conditions based on solubility
Selection of dissolution media volume using solubility data

Our analytical development services ensure the creation of robust, reproducible, and scientifically sound methods, supporting pharmaceutical research and formulation development.