Category
Benzylpenicillin
CAS Number
551-16-6
Molecular Formula
C₈H₁₂N₂O₃S
Molecular Weight
216.26 g/mol
Synonym

(2S,5R,6R)-6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid:6-Aminopenicillanic acid; 6-APA;

Keywords
Impurities Manufacturer in India
Impurities manufacturer and Suppliers in Hyderabad india
Aromatics
Amines
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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Benzylpenicillin EP Impurity A (CAS No. 551-16-6), also known as 6-Aminopenicillanic Acid (6-APA), with a Molecular Formula of C₈H₁₂N₂O₃S and Molecular Weight of 216.26 g/mol, is a pharmaceutical impurity reference standard and beta-lactam antibiotic-related compound used in Benzylpenicillin API impurity profiling, related substances analysis, impurity identification, purity determination, and analytical method validation. As an important Penicillin G-related impurity and pharmaceutical intermediate, it supports HPLC analysis, LC-MS/MS characterization, chromatographic method development, stability studies, and pharmaceutical quality control testing for Benzylpenicillin API and antibiotic formulations.

Manasa Life Sciences, a pharmaceutical impurity reference standards manufacturer and supplier in India, offers Benzylpenicillin EP Impurity A Analytical Reference Standard for antibiotic API manufacturers, pharmaceutical companies, CROs, CDMOs, and analytical testing laboratories. This Benzylpenicillin EP Impurity A HPLC Reference Standard supports impurity monitoring, analytical method verification, and pharmaceutical quality assessment in accordance with applicable International Council for Harmonisation (ICH) guidelines, European Medicines Agency (EMA) regulatory requirements, European Pharmacopoeia (EP), and United States Pharmacopeia (USP) analytical standards. Product-specific Certificate of Analysis (COA), SDS/MSDS, chromatographic purity data, and analytical characterization reports may be available upon request, subject to availability.