Premium Pharmaceutical Intermediates & Analytical Standards – Pharmaffiliates
Published Nov 12, 2025 by pharmaffiliates
Pharmaffiliates offers a wide-ranging portfolio of high-purity pharmaceutical intermediates, metabolites, and impurity standards, specifically designed to support drug discovery, analytical research, and regulatory compliance. With over 20 years of industry experience, our ISO 17025-certified and US FDA-audited facilities ensure that every compound meets the highest standards of quality and consistency.
Our catalog is crafted for pharmaceutical R&D teams, providing reliable reference standards for stability testing, impurity profiling, pharmacokinetic studies, and analytical method validation. By leveraging our expertise, research organizations can accelerate innovation while maintaining full compliance with FDA, EMA, and ICH Q3 guidelines.
Why Choose High-Purity Intermediates & Impurity Standards
High-purity intermediates and impurity standards play a critical role in pharmaceutical research by enabling:
- Accurate impurity profiling and validation of analytical methods
- Reliable pharmacokinetic and metabolic studies
- Optimization of synthetic pathways for new drug candidates
- Compliance with global regulatory standards
These chemicals are indispensable for medicinal chemistry research, synthetic route development, and drug metabolism studies, supporting the safe and effective development of pharmaceutical products.
Catalog of Featured Compounds
4-(tert-Butyl)-N-(6-(2-(2-hydroxyethoxy)ethoxy)-5-(2-methoxyphenoxy)-[2,2'-bipyrimidin]-4-yl)benzenesulfonamide (CAS 1257099-43-6)
- Type: Pharmaceutical Intermediate / Impurity Standard
- Significance: A complex bipyrimidine derivative that acts as a critical intermediate for developing novel therapeutic candidates. Supports heterocyclic chemistry and medicinal chemistry R&D.
- Applications: Synthetic pathway optimization, impurity profiling, advanced heterocyclic chemistry studies.
- Regulatory & Quality Advantage: Supplied with COA, MSDS, NMR, HPLC, produced in ISO 17025-certified, US FDA audited facilities.
Isopropyl 4-(1-Methyl-5-nitro-1H-benzo[d]imidazol-2-yl)Butanoate (CAS 1374784-01-6)
- Type: Heterocyclic Pharmaceutical Intermediate / Impurity Standard
- Significance: Nitro-substituted benzimidazole derivative, valuable for small-molecule therapeutic development.
- Applications: Synthetic route development, impurity profiling, structural optimization, pharmacokinetic studies.
- Regulatory & Quality Advantage: COA, MSDS validated; ensures reproducibility and FDA/EMA compliance.
3-Bromo-2-(1-methoxybutyl)benzofuran (CAS 1391053-51-2)
- Type: Benzofuran Derivative / Pharmaceutical Intermediate
- Significance: Supports novel therapeutic molecule development and impurity profiling.
- Applications: Synthetic route development, analytical method validation, heterocyclic chemistry studies.
- Regulatory & Quality Advantage: Delivered with COA, MSDS, produced under US FDA audited standards.
Carboxy Pioglitazone (M-V) (CAS 146062-48-8)
- Type: Pharmaceutical Metabolite / Impurity Standard
- Significance: Key metabolite of Pioglitazone for pharmacokinetic studies, metabolic profiling, and stability analysis.
- Applications: Synthetic pathway optimization, analytical method validation, metabolic studies.
- Regulatory & Quality Advantage: Validated COA/MSDS; produced in ISO 17025-certified and US FDA audited facilities.
Carbasalate Calcium Impurity A (CAS 1466-82-6)
- Type: Pharmaceutical Impurity Standard
- Significance: Recognized impurity of Carbasalate Calcium ensuring accurate quality control and regulatory compliance.
- Applications: Stability studies, impurity profiling, analytical method validation for antiplatelet agents.
- Regulatory & Quality Advantage: Complete analytical validation with FDA-compliant documentation.
Ethyl 4-(1-phenethyl-1H-imidazole-2-carbonyl)piperidine-1-carboxylate (CAS 147082-77-7)
- Type: Pharmaceutical Intermediate / Impurity Standard
- Significance: Crucial intermediate for CNS-active drug development.
- Applications: Synthetic pathway optimization, impurity profiling, structural optimization in drug discovery.
- Regulatory & Quality Advantage: Supplied with COA, MSDS, ensuring regulatory compliance and reproducibility.
1-Methyl-ethynyl-estradiol (CAS 15071-66-6)
- Type: Steroidal Compound / Pharmaceutical Intermediate
- Significance: Synthetic steroidal compound used in contraceptive and hormone replacement therapy research.
- Applications: Synthetic route development, impurity profiling, pharmacological testing.
- Regulatory & Quality Advantage: Validated analytical data; produced in ISO 17025 and US FDA audited facilities.
4-Methyl-ethynyl-estradiol (CAS 155683-61-7)
- Type: Steroidal Compound / Pharmaceutical Intermediate
- Significance: Supports development of contraceptive agents and hormone therapies.
- Applications: Synthetic pathway optimization, impurity profiling, pharmacological testing.
- Regulatory & Quality Advantage: Supplied with COA, MSDS, HPLC, ensuring FDA/ICH compliance.
Dexamethasone Acetate Impurity G (CAS 1597-78-0)
- Type: Pharmaceutical Impurity Standard
- Significance: Recognized impurity of Dexamethasone Acetate, used for quality control and regulatory studies.
- Applications: Stability studies, impurity profiling, analytical method validation for corticosteroid formulations.
- Regulatory & Quality Advantage: Validated COA/MSDS; produced in US FDA audited and ISO-certified facilities.
Pharmaffiliates Advantage / Highlights
- High-purity pharmaceutical intermediates, metabolites, and impurity standards
- ISO 17025-certified laboratories
- US FDA audited facilities
- Compliance-ready documentation (COA, MSDS, NMR, HPLC)
- Custom synthesis and global supply capabilities
References & Regulatory Compliance
- U.S. FDA Guidelines: https://www.fda.gov/
- EMA Guidelines on Impurities: https://www.ema.europa.eu
- ICH Q3(R2) Impurities Guidelines: https://www.ich.org
