NABL Accredited · Inorganic Analysis Laboratory

Elemental Analysis (CHNS) Laboratory India | NABL Accredited

CHNS elemental analysis and ICH Q3D elemental impurity testing from an NABL-accredited pharmaceutical laboratory in India.

Elemental analysis encompasses two distinct but complementary capabilities in pharmaceutical testing. CHNS combustion analysis determines the organic elemental composition of drug substances — providing carbon, hydrogen, nitrogen, and sulphur percentages that confirm molecular identity and purity. ICP-based elemental impurity analysis determines trace metal and metalloid levels per ICH Q3D requirements, ensuring pharmaceutical products meet permitted daily exposure limits for all 24 target elements.

Auriga Research operates an NABL-accredited elemental analysis laboratory equipped with high-precision CHNS analysers for combustion-based organic elemental determination and ICP-MS/ICP-OES systems for trace-level inorganic elemental impurity quantification. Our CHNS analyser delivers accuracy within 0.3% absolute for each element, while our ICP-MS provides detection limits in the low parts-per-trillion range — well below the PDE-derived specification limits required by ICH Q3D.

Applications include API identity confirmation and purity assessment by CHNS, ICH Q3D compliance testing for drug substances and drug products, elemental impurity risk assessment for manufacturing process evaluation, and catalyst residue quantification in synthetic API manufacturing.

Elemental Analysis Capabilities

  • CHNS combustion analysis for carbon, hydrogen, nitrogen, and sulphur determination
  • ICH Q3D elemental impurity testing for all 24 target elements by ICP-MS
  • ICP-OES for higher-concentration elemental determinations
  • Oxygen determination by pyrolysis for CHNO analysis
  • Catalyst residue quantification (Pd, Pt, Rh, Ru, Ir, Os)
  • Validated methods for oral, parenteral, and inhalation drug product routes
  • Microwave-assisted acid digestion for complex pharmaceutical matrices
  • Empirical formula verification and stoichiometric confirmation

Turnaround Time

CHNS Analysis: 3-5 business days
ICH Q3D Elemental Impurities: 5-7 business days
Rush Testing: 2-3 business days
Comprehensive Elemental Package: 7-10 business days

Related Testing Services

Impurity Profiling Raw Material Testing NABL Accredited Lab All Pharma Testing →

Frequently Asked Questions — Elemental Analysis

What is CHNS elemental analysis?
CHNS elemental analysis is a technique that determines the percentage composition of carbon (C), hydrogen (H), nitrogen (N), and sulphur (S) in organic compounds through combustion analysis. A precisely weighed sample is combusted at high temperature (typically 950-1050 C) in an oxygen-enriched atmosphere, and the resulting gases (CO2, H2O, N2, SO2) are separated and quantified by thermal conductivity or infrared detection. CHNS analysis is used for identity confirmation, purity assessment, and empirical formula verification of pharmaceutical compounds.
How does elemental impurity testing per ICH Q3D work?
ICH Q3D elemental impurity testing determines the levels of 24 target elements (including Cd, Pb, As, Hg, Co, V, Ni, and others) in pharmaceutical products using ICP-MS or ICP-OES. The guideline classifies elements into three classes based on toxicity and likelihood of occurrence, and establishes permitted daily exposure (PDE) limits for each element based on the route of administration (oral, parenteral, inhalation). Testing ensures that elemental impurity levels in the final drug product do not exceed these safety limits.
What is the turnaround time for elemental analysis?
Standard CHNS elemental analysis at Auriga Research is completed within 3-5 business days. ICH Q3D elemental impurity testing by ICP-MS requires 5-7 business days. Rush services are available within 2-3 business days for both techniques. Combined packages are available for comprehensive elemental characterisation.

Need Elemental Analysis for Your Pharmaceutical Samples?

NABL-accredited CHNS and ICP-MS elemental analysis. ICH Q3D compliance testing with 3-5 day turnaround.

+91-7428116100 Get a Quote
Call Now Get a Quote

Type to search services, tests, and locations…