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ChemEngine Metabolites Division

High-Purity Reference Standards & Custom Metabolite Synthesis for Global Pharma.

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Supporting Drug Discovery & Safety Assessments

ChemEngine Pharma Solutions Pvt. Ltd. synthesizes high-purity, fully characterized drug metabolites to support drug discovery, safety assessments, and regulatory filings (FDA, EMA, ICH). We offer stable isotope-labeled metabolites, glucuronides, sulfates, and oxidative derivatives for preclinical and clinical research.

Core Product & Service Categories

Phase I Metabolites

Hydroxylated, N-demethylated, and oxidized derivatives synthesized via precise chemical or enzymatic pathways.

Phase II Conjugates

High-purity glucuronides, sulfates, and glutathione adducts critical for excretion and toxicity profiling.

Stable Isotope-Labeled

Deuterated (2H) and 13C-labeled analogs designed for highly accurate LC-MS/MS quantification.

Custom Synthesis

Target-specific metabolite synthesis based directly on in vitro (microsomal/hepatocyte) or in vivo profiling data.

Product Catalog Showcase

A glimpse into our meticulously synthesized structural classes.

Phase I Metabolite Structure
Phase I Pathway
Oxidative Derivatives

Reference standards ideal for early-stage ADME testing and metabolic stability profiling.

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Phase II Conjugate Structure
Phase II Pathway
Glucuronides & Sulfates

Highly complex conjugate structures essential for mapping drug excretion and safety profiling.

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Isotope Labeled Structure
SIL Standards
Isotope-Labeled Analogs

Internal standards perfectly calibrated for DMPK studies and bioanalytical LC-MS quantification.

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Metabolite Catalog & Capability Summary

Explore our analytical deliverables and standard purities across metabolite classifications.

Product / Service Category Typical Purity Analytical Deliverables Primary Applications
Phase I Drug Metabolites ≥ 95% (HPLC) HPLC, 1H-NMR, MS, COA Reference standards, ADME testing
Phase II Conjugates ≥ 90% (HPLC) HPLC, 1D/2D-NMR, LC-MS Excretion studies, safety profiling
Isotope-Labeled Standards ≥ 98% Isotopic Mass spec isotope distribution, NMR Bioanalytical internal standards (DMPK)
Custom Biosynthesis/Synthesis Custom specifications Complete characterization package Novel target isolation & identification
Chemist working with HPLC
ISO Certified
cGMP Aligned

Quality Assurance & Compliance

Regulatory compliance is at the forefront of our metabolite division. We ensure absolute certainty in our chemical characterizations to support your critical FDA, EMA, and ICH filings.

  • Complete Spectroscopic Characterization Every standard comes with an exhaustive data package including 1H/13C-NMR, HRMS, and precise HPLC purity traces.
  • Batch-to-Batch Consistency Rigorous synthetic protocols ensure exact reproducibility, with long-term stability testing data included upon request.
  • Secure International Shipping Delivered safely anywhere in the world under highly controlled cold-chain conditions to preserve molecular integrity.