Analytical Method Development & Validation Services
Analytical Method Development has gained a lot of importance because of its role in Analytical Instrumentation. With advantages like at most precision, accuracy & reduced time of analysis, drug development & food analysis .It ensures a cost effective solution to meet specific challenges of Process Development & Method Validation .Today's Pharmaceutical industry, complies with a wide range of standards published in pharmacopeia including IP, BP, USP. Spectro supports its clients with their need for method development & validation as per their specifications for reduction of time, cost along with catering to their need for accurate & precise results. Spectro has a team of highly skilled analysts for Method Development. Our team takes care of all your needs for Method Validation as well. Spectro Service for Method Development & Validation includes analysis of Assay, Stability, Purity, Degradation studies, Formulation development, Characterization, Process validation, Remedial validation, Method transfer, Comparative studies
Our Scope of Activities for Analytical Method Development Involve :-
Discussions with client
Planning the method development & validation policy as per requirement
For routine analysis, "QC Plan" will be developed
Review by QA & data submission to QC Department
Steps Involved at the Time of Validation :
New Sample with new compounds
Validation of samples from different analyst
New Instrument with different characteristics
Different environmental conditions, chemicals, analytical parameters etc.
Method is validated once its performance is verified
Stability Study :
The stability of a drug in biological fluid is a function of the storage conditions, chemical properties of drug, matrix, packing material used. Stability indication method is defined as a quantitative test method used to detect the degradation, impurities of the drug. The drug/food product is tested for its quality & degradation over a period of time & changes due to factors such as Temperature, Humidity, Light. SPECTRO conducts stability studies for Drugs as well as Food Products in accordance with ICH & WHO Guidelines.We conduct studies for Stability, API Release, and Drug Product release.
Impurity profiling helps in estimating the actual amount of different impurities present in a drug or food product under study .The source of impurities can be the Raw Material Used ,Method of manufacturing adopted ,Product Instability, Atmospheric contamination etc.