1Non-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.
[Non-Pharmacopoeial and Proprietary Combinations involve new Drugs and Excipients in Multiple Combinations requiring Advanced Processing / Formulation Strategies. Herein, Product Formulation, Development, and Optimization necessitate that constituents be Accurately Determined through Validated and appropriate Analytical Methodologies.]
2With the Advent of newer Drugs, Excipients & ultramodern Processing/ Formulation Strategies in combination with Two or more Drugs, there is a relevant need for legitimate Analytical Methods to determine them properly.
[The Advent of modernistic Drugs, Excipients & ultramodern Processing/ Formulation Strategies, and the combinations of two or more Drugs, has given rise to the need for legitimate Analytical Methods for their proper determination.]
This is generally applicable for Non-Pharmacopoeial Proprietary Combination Products and 3[is] therefore Essential for Formulation/ Product Development and Optimization.
4EFRAC offers Economical and Strategic solutions for Method Development, Validation, Verification, Optimization Improvement, Qualification & Transfer Studies for a wide range of Modern Drugs, Ayurvedic Drugs, Nutraceuticals & Cosmetic Products. At EFRAC, the advanced lab also critically adheres to the Quality Standards & Integrity which are the backbone for any new Drug Delivery into the Market. Our Integrated Approach to Analytical Method Standardization, all stages of Pharmaceutical Fabrication Processes namely APIs, Intermediates & all types of Dosage Forms or Finished Products has been successfully Executed in many High-Volume Projects for Clients by maintaining Strict Deadlines.
[EFRAC offers Economical and Strategical solutions for Method Development, Validation, Verification, Optimization Improvement, Qualification & Transfer Studies for a wide range of Modern & Ayurvedic Drugs, Nutraceuticals, and Cosmetic Products. An advanced laboratory, it stringently adheres to Quality & Integrity Standards which constitute the procedural backbone of new Drugs before their introduction to the Market. EFRAC’s Integrated Approach to Analytical Method Standardization in all the stages of Pharmaceutical Fabrication Processes namely APIs, Intermediates & all types of Dosage Forms or Finished Products has led to the successful execution of 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 Rest [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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