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Chemical Discipline
FDCA Form 37 Approved21 CFR Part 11 Compliant
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Elemental Impurity Testing

ICH Q3D-compliant testing of elemental impurities in APIs, drug products, and raw materials using ICP-OES and ICP-MS.

ICH Q3DICP-MSICP-OESMetals
Elements Tested24 ICH Q3D elements
Detection LimitSub-ppb (ICP-MS)
Turnaround Time7–10 working days
Regulatory AcceptanceUSFDA, EMA, ICH
● Lab Capacity ActiveForm 37 Certified

Study Protocol Support

Direct access to analytical specialists for study design, method validation, and turnaround timelines.

Submit Sample MatrixDownload Service Spec Sheet
Direct Technical Desk:+91 76240 54108
Service Scope & Regulatory Framework

Rigorous Scientific Execution Built for Global Regulatory Dossiers

Our elemental impurity testing service provides ICH Q3D and USP <232>/<233> compliant analysis of 24 elemental impurities in pharmaceutical products. Using ICP-OES and ICP-MS with microwave digestion, we deliver accurate, sensitive, and regulatory-compliant results for APIs, drug products, excipients, and packaging materials.

Compendial Standards & Regulatory Alignment:
✓ ICH Q3D✓ USP <232>✓ USP <233>✓ EP 5.20✓ JP
Dual-Analyst Review

100% 4-eye verification of all chromatograms, integrations, and calculations before CoA generation.

ALCOA+ Data Integrity

Direct electronic data capture with immutable audit trails, restricted rights, and disaster backups.

Technical SpecificationscGLP Compliant

Elements Tested24 ICH Q3D elements
Detection LimitSub-ppb (ICP-MS)
Turnaround Time7–10 working days
Regulatory AcceptanceUSFDA, EMA, ICH
Quality Credentials
FDCA Gujarat Form 37ICH Compliant (Q1–Q14)21 CFR Part 11
Key Analytical Capabilities

What's Covered in the Testing Scope

Comprehensive assay, stability, and characterization endpoints validated to global pharmacopoeial standards.

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All 24 ICH Q3D elemental impuritiesExecuted with validated SOPs and full raw data audit trails.
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Class 1 elements: As, Cd, Hg, PbExecuted with validated SOPs and full raw data audit trails.
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Class 2A elements: Co, Ni, VExecuted with validated SOPs and full raw data audit trails.
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Class 2B elements: Ag, Au, Ir, Os, Pd, Pt, Rh, Ru, Se, TlExecuted with validated SOPs and full raw data audit trails.
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Class 3 elements: Ba, Cr, Cu, Li, Mo, Sb, SnExecuted with validated SOPs and full raw data audit trails.
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Risk assessment supportExecuted with validated SOPs and full raw data audit trails.
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Oral, parenteral, and inhalation PDEsExecuted with validated SOPs and full raw data audit trails.
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Excipient and raw material testingExecuted with validated SOPs and full raw data audit trails.
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Packaging material extractablesExecuted with validated SOPs and full raw data audit trails.
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Method validation per USP <233>Executed with validated SOPs and full raw data audit trails.
Qualified Laboratory Infrastructure

Validated Instrumentation & Data Systems

All instruments operate with full IQ/OQ/PQ qualification, automated audit trails, and 21 CFR Part 11 software packages.

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ICP-MS

Trace elemental analysis at ppb/ppt levels

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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ICP-OES

Multi-element analysis at ppm levels

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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Microwave Digestion System

Sample preparation for metals analysis

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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AAS (Flame/Graphite Furnace)

Single element confirmation analysis

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
Study Execution Lifecycle

How We Execute Your Study

Standardized 4-stage laboratory workflow ensuring traceability from sample intake to CoA release.

01
Stage 01

Risk Assessment

Elemental impurity risk assessment performed per ICH Q3D decision tree.

02
Stage 02

Sample Preparation

Microwave-assisted acid digestion with certified reference standards.

03
Stage 03

ICP-MS/OES Analysis

Multi-element analysis with internal standards for accuracy and precision.

04
Stage 04

PDE Comparison & Report

Results compared against PDEs; compliance statement and full report issued.

Scientific Questions & Answers

Technical FAQs

Standard testing is delivered in 7–10 working days. Expedited priority slots are available upon request with dedicated instrument reservations and expedited QC review.
Ready for Sample Testing?

Initiate Your Elemental Impurity Testing Study

Submit your sample matrix or request a pre-study analytical protocol discussion with our senior scientists today.

Schedule Scientific Consultation
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