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'Lenacapavir' related Reference Standards & Products

Showing 10–18 of 63 results

 

As a supplier of high-purity analytical standards, we offer a comprehensive portfolio of Lenacapavir impurities designed for pharmaceutical retailers, API manufacturers, and regulatory bodies. Our products support every stage of drug development and quality assurance—from forced-degradation profiling to method validation and stability studies.

🧪 Our Popular Product Range
Lenacapavir Impurity 1 (CAS 2189680‑65‑5):
Low-molecular-weight degradation fragment (~282 g/mol; molecular formula C₁₀H₇F₅N₂O₂), ideal for calibration of early degradation peaks in HPLC/LC‑MS assays

Lenacapavir Impurity 7:
(R)-1 (3‑bromo‑6‑(3‑methyl‑3‑(methylsulfonyl)but‑1‑yn‑1‑yl)pyridin‑2‑yl)-2‑(3,5‑difluorophenyl)ethan-1‑amine, MW ~457.3 g/mol—commonly used to monitor forced‑degradation products and validate stability testing

Lenacapavir Impurity 9:
High‑molecular-weight impurity (~721.5 g/mol; molecular formula C₂₉H₂₄BrF₇N₄O₃S), often encountered as a late-stage synthetic impurity or degradation marker

Other Available Standards:
Including Impurities 4, 5, and 60—representing bromopyridine intermediates, process markers, and custom impurities with detailed char-acterization data

✅ Why Our Standards Are Trusted
Regulatory-Grade Quality:
Each impurity standard is supplied with a Certificate of Analysis (CoA), stability data, and traceability to pharmacopeial reference or internal benchmarks to support DMF, ANDA, NDA approvals or stability submissions

Full Characterization:
Provided technical documentation includes purity analysis, structural confirmation (NMR, MS), and retention behavior—crucial for reliable method development and validation

Analytical & Method Validation Utility:
Ideal for forced-degradation studies, impurity profiling, and QC testing of Lenacapavir API or formulated dosage forms

Custom & Isotopically Labeled Compounds:
Capabilities include traceable isotopes (e.g., ^13C/^2H₃‑Lenacapavir), metabolites, and nitrosamine impurity analogs, based on customer specifications

Compliance with ICH Q3A/Q3B Guidelines:
Supports global regulatory alignment by providing reference standards for specified and unspecified impurities, aiding impurity limits documentation and validation.

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