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Analytical Method Development and Validation
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Analytical Method Development and Validation

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Analytical Method Development
When is Analytical Method Development required ?
Analytical Method Development is required for :
» Herbal Products
» New process and reactions
» New molecules
» Active ingredients (Macro analysis)
» Residues (Microanalysis)
» Impurity
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Shriram Institute For Industrial Research

University Area North Campus, New Delhi
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Analytical Method Development 
When is Analytical Method Development required ? 

Analytical Method Development is required for :
» Herbal Products
» New process and reactions
» New molecules 
» Active ingredients (Macro analysis)
» Residues (Microanalysis) 
» Impurity Profiling 
» Component of Interest in different matrices

What does analytical methodology consist of ?
An Analytical Methodology consists of the following
» Techniques
» Method
» Procedure
» Protocol
What does analytical methodology provide to an analyst ?
» The required data for a given analytical problem
» The required sensitivity
» The required accuracy
» The required range of analysis
» The required precision 
i.e. the minimum requirements which essentially are the specifications of the method for the intended purpose: To be able to analyse the desired analyte in different matrices with surety and certainity.

What are the capabilities of SRI in method development ?
SRI has the trained expertise and all the state-of-the-art-facilities required for developing new methods of analysis for all kinds of components in different complex matrices. The methods developed by SRI can be used by other laboratories. The capability of SRI in this area has been acknowledged by the international bodies concerned with the quality standards and systems.

What is Method Validation / Evaluation ?
Method validation is the process of documenting or proving that :
Analytical Method provides analytical data for the intended use
Why is analytical method validation required ?

Method Validation is required for the following reasons
» Assuring quality and achieving 3 a levels
» Achieving acceptance of products by the international agencies.
» Mandatory requirement purposes for accreditation as per ISO 17025 guidelines
» Mandatory requirement for registration of any pharmaceutical product or Pesticide formulation
» Validated methods are only acceptable for undertaking proficiency testing.
What are the various parameters studied for Method Validation ? 
» For validation the developed method is subjected to following studies :
» Precision / Reproducibility
» Accuracy
» Linearity
» Specificity / Selectivity
» Limit of detection
» Limit of quantitation
» Robustness / Ruggedness
General Process of Validation / Evaluation of Methodology
At SRI, besides the Method Development, the Method Validation Studies for the developed methods for various parameters as per the following protocols and guide lines are being regularly undertaken.
» EN 45 000 series of standards
» ISO / IEC Guide 25
» International Conference on Harmnization (ICH)
» United States Pharmacopoeia
» Published Literature

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Analytical Method Development and Validation

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About us

Year of Establishment1941
Legal Status of FirmTrust
Nature of BusinessService Provider
Number of Employees101 to 500 People
Annual Turnover2008-09 Rs. 10-25 Crore Approx.
2009-10 Rs. 10-25 Crore Approx.
2010-11 Rs. 10-25 Crore Approx.
IndiaMART Member SinceAug 2003
Shriram Institute for Industrial Research (SRI) is an independent, self sustaining, not-for-profit multidisciplinary contract research institute conducting research and development in the areas of special significance to industry, government agencies and other organizations. SRI is committed to develop, innovate, analyse and apply technology for products and processes. SRI also brings its innovations to the marketplace by licensing its technologies and helps in establishing production units for the interested clients. SRI founded in the year 1947 by an illustrious founder Lala Shriram, started functioning in 1950. Lala Shriram believed that if India was to catch up with the rest of the world, it was necessary to understand existing technology and innovate it through research. SRI's strengths have been its staff, a knowledgeable, expert and experienced Governing Board and an innovative management. SRI is operational from Delhi and Bangalore. SRI's thrust areas are Materials Science, Analytical Science, Life Science, Irradiation of Medical and Surgical products and Quality Assurance. Recent thrust areas in material science includes Blood bags, Cactus Latex based products, Biomaterials, Materials for Aero Space Applications, Polymers for Electronics, Hightech Adhesives, Polymers, Composites, Specialty Chemicals, Renewable resources, Radiation based Technologies, Herbal Products, Waste Utilization, Technical Consultancy etc. The Analytical Sciences Division provides prompt, precise and dependable analytical services in the fields of metal and minerals, rubber and plastics, building materials, paper, leather and textiles, chemicals and agro chemicals, food and pharmaceuticals, petroleum products, home appliances and Microbiological studies. The Division standardises develop and validate new methods for analysis . It provides assistance to customers to ensure the quality of products laid down by various certifying agencies and statutory bodies. It also provides Calibration services. SRI's Life Sciences Division conducts research on various aspects of Environment including Biological Impact Studies, Rapid Environmental Impact Studies and Comprehensive Environmental Impact Studies. The Division undertakes toxicological studies to establish safety levels of chemicals, agrochemicals and herbal products Shriram Applied Radiation Centre, SARC, established with the technical assistance of BARC, conducts research in plymer modifications and undertakes irradiation of life saving medical and surgical products and spices. SRI's uncompromising commitment to excellence in research is underscored by its own Quality Assurance Division which ensures that the Institute itself adheres to the highest standards of scientific investigation and service.
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