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
  • Data Compilation

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
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.