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 Development & Validation
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
• 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
Drug & Cosmetic 
Microbiological 
Method 
Waste 
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