1. Method Development & Validation - EFRAC | Drug, Food, Gas, Proficiency Testing Laboratory
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    METHOD DEVELOPMENT & VALIDATION

    Non-Pharmacopoeial and Proprietary Combinations involve new Drugs and Excipients in Multiple Combinations and require Advanced Processing / Formulation Strategies. Thus, Product Formulation, Development, and Optimization necessitate that constituents be Accurately Determined through Validated and appropriate Analytical Methodologies.

    With the Advent of newer Drugs, Excipients & newer Processing/ Formulation Strategies in combination with Two or more Drugs, there is a relevant need for legitimate Analytical Methods to determine them properly. This is generally applicable for Non-Pharmacopoeial Proprietary Combination Products and therefore Essential for Formulation/ Product Development and Optimization.

    EFRAC offers Cost Effective Strategic Solutions for Method Development, Validation, Verification, Optimization Improvement, Qualification & Transfer Studies for a wide range of Modern Drugs, Ayurvedic Drugs, Nutraceuticals & Cosmetic Products. EFRAC’s advanced Laboratory stringently adheres to the Standards of Quality & Integrity that are the backbone for Delivery of New Drugs into the Market. EFRAC’s Integrated Approach to Analytical Method Standardization, all stages of Pharmaceutical Fabrication Processes namely APIs, Intermediates & all types of Dosage Forms or Finished Products have been successfully Executed in many High-Volume Projects for Clients within Strict Deadlines.

    method efrac

    Method Development & Validation

    Services

    PARAMETERS

    Accuracy: Closeness of Test Results to the True Value across the Range

    Precision: Degree of Agreement among Individual Test Results applied repeatedly to Multiple Samples of a Homogeneous Sample.

    Specificity/Selectivity: Ability to assess the Analyte in the presence of Components expected to be present.

    Detection Limit (LOD): The Lowest amount of Analyte that can be Detected under the Stated Experimental Conditions.

    Quantitation Limit (LOQ): The Lowest amount of Analyte that can be determined with Acceptable Precision and Accuracy under the stated Experimental Conditions.

    Linearity: The ability to elicit Test Results that are Proportional to the Concentration of the Analyte within a given Range.

    Range: The Interval between the Upper and Lower Levels of Analyte that have been demonstrated to be determined with a Suitable Level of Precision, Accuracy, and Linearity.

    Robustness: The measure of its Capacity to remain Unaffected by Small but Deliberate Variations in Procedural Parameters.

    Studies conducted: Assay • Dissolution • Excipients like Preservatives and Stabilizers • Impurities and Related Substances • Microbiological Tests • Organic Volatile Impurities and Residual Solvents • Physico-Chemical Tests • Trace Elements • Metals • Metalloids and Heavy Metals

    INSTRUMENTS

    • AAS – (Flame, GTA, VGA)
    • Digital Polarimeter
    • Digital Refractometer
    • Dissolution Test Apparatus
    • Flame Photometer
    • FT-IR
    • GC- (FID)
    • GC- (HEADSPACE, ECD, MS)
    • GC-MS MS (QQQ)
    • HPLC (FLD, PDA, ELSD, RID)
    • IC
    • ICP-MS
    • LC-MS-MS (QQQ)
    • Potentiometer
    • UV -Visible Spectrophotometer
    • DSC
    • TGA
    • Particle Size Analyzer