Pharmaceutical Reference Standards Supporting Advanced Analytical Research
In the evolving landscape of pharmaceutical research, the reliability of analytical data depends heavily on the accuracy and traceability of reference standards. These compounds form the foundation for method validation, impurity profiling, and structural elucidation across multiple therapeutic domains.
Pharmaffiliates, a trusted manufacturer and exporter of pharmaceutical reference standards in India, offers a broad portfolio exceeding 50,000 analytical materials, including impurities, metabolites, intermediates, and working standards. Each reference material is produced under stringent ISO 9001 and ISO/IEC 17025 guidelines, ensuring traceability and purity for both regulatory and research applications.
D-2′-Deoxyribofuranosyl-3-Guanylurea (α/β-Mixture) Formic Acid Salt
Product Code: PA 04 0751027
This compound, a nucleoside analog derivative, serves as a vital analytical standard for nucleic acid modification and degradation studies. The α/β mixture form enhances the relevance of this material in complex chromatographic separations where stereochemical accuracy is essential.
Pharmaffiliates supply this compound as a high-purity formic acid salt, offering researchers reproducible data for pharmacokinetic studies and DNA repair mechanism exploration. As a manufacturer in India, Pharmaffiliates ensures precise structural confirmation via NMR, IR, and LC-MS data provided in its certificate of analysis (COA).
Dicloxacillin Penicillamide
Product Code: PA 04 2531001
CAS Number: 2924817-36-5
Synonyms: Dicloxacillin Sodium Monohydrate – Impurity E (EP/BP); (2S,5R,6R)-6-[(2S,5R,6R)-6-[3-(2,6-Dichlorophenyl)-5-methyl-1,2-oxazol-4-amido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptan-2-amido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid; Dicloxacillin penicillamide (USP)
Dicloxacillin Penicillamide acts as an essential impurity reference standard used in β-lactam antibiotic analysis and stability profiling. It helps ensure that residual impurities in Dicloxacillin formulations remain within pharmacopeial limits, thereby guaranteeing patient safety.
Pharmaffiliates, as a leading manufacturer of impurity standards in India, synthesizes this compound under controlled conditions to meet regulatory requirements (EP/BP/USP). Its precise impurity identification supports method validation, LC–MS quantification, and impurity trend analysis in pharmaceutical quality control.
N-Benzyl Vinyl Analog
Product Code: PA 04 65540
CAS Number: 2250243-56-0
Synonyms: 1H-Imidazole, 5-[1-(2,3-dimethylphenyl)ethenyl]-1-(phenylmethyl); 1-Benzyl-5-[1-(2,3-dimethylphenyl)vinyl]-1H-imidazole (USP)
This imidazole-based analog is a significant impurity marker in certain antihistaminic formulations. It aids in elucidating degradation pathways during accelerated stability studies and offers insight into isomeric transformations in imidazole derivatives.
Pharmaffiliates’ role as a global manufacturer and supplier of research-grade impurity standards ensures that each batch is characterized for both stereochemical configuration and mass spectral integrity, providing confidence to analytical chemists performing LC–MS or HPLC analyses.
D-2′-Deoxyribofuranosyl-3-Guanylurea (α/β-Mixture)
Product Code: PA 04 75600
CAS Number: 570410-72-9
Synonyms: N-(Aminoiminomethyl)-N′-(2-deoxy-D-erythro-pentofuranosyl)urea; 1-(2-Deoxy-d-ribofuranosyl)-3-guanylurea; Decitabine Related Compound F (USP)
Closely related to Decitabine impurities, this nucleoside analog is utilized in epigenetic drug development and degradation pathway assessment. The α/β-mixture represents a realistic model for evaluating enantiomeric purity and oligonucleotide stability in pharmaceutical formulations.
Pharmaffiliates provides this reference material as part of its nucleoside impurity standard range, serving global researchers and QC laboratories engaged in oncology and nucleic acid-based therapeutic research.
4-(3-(4-Cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-2,4-dioxoimidazolidin-1-yl)-2-fluoro-N-methylbenzamide
Product Code: PA 05 55510
CAS Number: 1242137-18-3
Synonyms: 2-Fluoro-N-methylbenzamide, 4-(3-(4-cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-2,4-dioxoimidazolidin-1-yl)-
This fluorinated benzamide derivative represents a structurally complex impurity often studied for metabolic stability and toxicological evaluation in drug discovery pipelines. Its strong electron-withdrawing substituents (cyano and trifluoromethyl groups) make it a relevant analyte for mass spectrometry calibration and trace impurity identification.
Pharmaffiliates synthesizes this material under GMP-compliant analytical conditions, ensuring reproducibility and traceability. Available for bulk and small-scale research use, this compound exemplifies the company’s expertise as a pharmaceutical reference standard manufacturer in India.
(3R,4R,5R)-2-(4-Chloro-3-(4-(((R)-tetrahydrofuran-3-yl)oxy)benzyl)phenyl)-5-((R)-1,2-dihydroxyethyl)tetrahydrofuran-3,4-diol
Product Code: PA 05 56630
Synonyms: Empagliflozin Impurity B (Mixture of Diastereomers); Tetrahydrofuran-3,4-diol, (3R,4R,5R)-2-(4-chloro-3-(4-(((R)-tetrahydrofuran-3-yl)oxy)benzyl)phenyl)-5-((R)-1,2-dihydroxyethyl)-
This compound is an Empagliflozin-related impurity, instrumental in the characterization and stability profiling of SGLT2 inhibitor APIs. Its diastereomeric mixture provides a realistic model for chromatographic resolution studies and impurity threshold quantification as per ICH Q3A/B guidelines.
Pharmaffiliates’ controlled synthesis of such stereochemically complex impurities reinforces its reputation as a trusted global supplier and manufacturer of impurity reference standards, catering to diabetes and metabolic drug research laboratories.
Conclusion
These six reference materials collectively demonstrate Pharmaffiliates capability to advance analytical precision and regulatory compliance through scientifically validated standards. Each compound, supported by complete COA, spectral data, and MSDS, enhances data integrity across pharmaceutical R&D workflows.
As a leading manufacturer of pharmaceutical reference standards in India, Pharmaffiliates continues to empower laboratories worldwide with traceable, high-purity impurities and metabolites essential for quality assurance, stability testing, and method validation
