Analytical Method DEVELOPMENT & vALIDATION

Analytical method development and Validation of analytical methods must be completed to determine performance characteristics for the intended analytical application. Depending on performance characteristics, validation parameters may change. In general, we follows ICH, FDA,USP guidelines for methods validation.

Teena Biolabs has a department of senior level technical team that is dedicated to performing method development and ICH method validation services. Our technical team has years of experience working on stability indicating methods, residual solvent methods, dissolution methods and specific and non-specific cleaning validation methods. We have our own protocols that comply with ICH and FDA guidelines or we can follow client-supplied protocols. Our analytical development services include pharmaceutical method development services and also offer USP method validation services. Teena Bio offers Method Development and validation services using a wide range of technologies including PSD, ICP, HPLC, UV and GC.

Precision
Intermediate Precision and Ruggedness
Linearity
Accuracy
Range
Specificity
Forced Degradation Studies
Limit of Detection/Limit of Quantization
Stability of Standard and Sample Solutions
Photo stability study
Robustness

TBPL brings years of experience performing all types of Analytical testing on many drug substances, drug products and medical devices. We bring the highest level of quality and attention to detail to our clients to assure that their analytical method development and validation projects are successfully executed. Our experience covers the spectrum of pharmaceutical development phase I, II and II.

Stability/PHOTO STABILITY Studies

TBPL has the experienced team capable to lead the process from protocol design to storage, monitoring, analytical testing and documentation.
A complete range of storage conditions in multiple climatic chambers
The stability units have operational back-ups and are fully controlled with 24x7 monitoring and alert systems
Customer-specific conditions can also be accommodated
Long term and Stress conditions (accelerated).Drug products Drug substances Intermediates Hold time study
Photo stability studies

Extractable & Leachable studies:

We have scientists with rich experience in performing Extractable & Leachable Studies as per Good manufacturing practices, PQRI recommendations, and FDA guidelines on,