Applications of Certified Reference Standards in Analytical and Material Science Research
Certified reference standards (CRSs) play a pivotal role in ensuring analytical precision, regulatory compliance, and reproducibility across scientific research. In pharmaceutical and chemical domains, their use extends from impurity profiling and method validation to material synthesis and quality assurance.
At Pharmaffiliates, each reference material is characterized, tested, and authenticated using advanced analytical methodologies to ensure traceability and consistency. The following overview highlights select research-grade compounds and their critical applications across chemical synthesis and analytical studies.
2-tert-Octylphenol (PA ENV 001481 | CAS No. 3884-95-5)
Synonyms: Phenol, 2-(1,1,3,3-tetramethylbutyl); o-tert-OctylphenolApplications: 2-tert-Octylphenol serves as an essential intermediate in the synthesis of surfactants, resins, and polymeric materials. It is extensively used in material science for modifying polymer properties, enhancing hydrophobicity, and improving resistance to oxidative degradation. As a reference compound, it is employed for the qualitative and quantitative determination of alkylphenolic contaminants and for calibration in environmental and toxicological studies.
N-Nitrosomethylethylamine (PA PST 010450 | CAS No. 10595-95-6)
Synonyms: N-Nitrosoethylmethylamine; N-Methyl-N-nitrosoethanamine; NEMAApplications:N-Nitrosomethylethylamine (NMEA) is a model nitrosamine impurity widely used in toxicological research and analytical validation of nitrosamine detection methods. Given the recent global focus on nitrosamine contamination in pharmaceuticals, this compound functions as a critical calibration standard for the development of LC-MS/MS and GC-MS analytical methods, supporting regulatory studies and risk assessment.
3-Ethyl-5-methyl-4-(2-chlorophenyl)-2-((2-(2-((2-hydroxyethyl)carbamoyl)benzamido)ethoxy)methyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate (PA 01 0491020 | CAS No. 3079028-35-3)
Synonyms: Hydroxyethyl Phthalyl Amlodipine (USP)Applications:This compound is a USP-defined impurity of Amlodipine, used as a reference standard in the quality control of calcium channel blockers. It supports method validation, impurity profiling, and stability testing in pharmaceutical R&D. Its accurate quantification helps in verifying compliance with pharmacopoeial monographs and international regulatory guidelines.
Bromhexine Levulinamide (PA 02 0481001)
Synonyms: N-(2,4-Dibromo-6-((cyclohexyl(methyl)amino)methyl)phenyl)-4-oxopentanamideApplications:Bromhexine Levulinamide acts as an intermediate and impurity marker in the synthesis and analytical evaluation of Bromhexine and its derivatives.It aids in the characterization of process-related impurities and is utilized for developing chromatographic purity profiles in respiratory drug formulations.
N-(5-Bromo-6-quinoxalinyl)guanidine Hydrochloride (PA 02 44051 | CAS No. 1797986-78-7)
Synonyms: 1-(5-Bromoquinoxalin-6-yl)guanidine Hydrochloride; Brimonidine Impurity E HydrochlorideApplications:Used as a reference impurity standard for Brimonidine, this compound is essential in ophthalmic drug impurity profiling and HPLC method standardization.Its availability as a characterized reference supports regulatory submissions, analytical reproducibility, and traceability in pharmaceutical impurity testing.
2-(2-(Diethylamino)ethoxy)ethyl 2-phenylacetate (PA 02 74530 | CAS No. 47092-75-1)
Synonyms: α-Desethyl Butamirate; Benzeneacetic Acid 2-[2-(Diethylamino)ethoxy]ethyl Ester; Butamirate Impurity 2Applications:This compound is a reference impurity standard for Butamirate, widely used in analytical method validation and impurity quantification in cough suppressant formulations.It supports LC and GC analysis for impurity identification and method linearity evaluation, enhancing analytical precision in quality control laboratories.
Conclusion
These reference materials collectively illustrate Pharmaffiliates’ commitment to advancing scientific research through traceable, high-purity analytical standards.
As a globally recognized manufacturer of certified reference standards in India, Pharmaffiliates ensures every compound is developed, characterized, and validated under stringent quality protocols.
Each standard serves a distinct role in method development, impurity analysis, and material science exploration, reinforcing data accuracy, reproducibility, and regulatory confidence across research and pharmaceutical applications.
