ICH Q3D & USP <232>/<233>

Trace Elemental Impurities Testing via ICP-OES & Microwave Digestion

Elemental impurities in pharmaceuticals pose toxicological risks and must be controlled to established Permitted Daily Exposure (PDE) limits under ICH Q3D. Our elemental analysis workflow begins with high-pressure, closed-vessel microwave acid digestion ensuring 100% analyte recovery without volatile element loss, followed by dual-view ICP-OES plasma quantitation.

Standard Turnaround
5 - 7 business days
Testing Facility
8,500 sq. ft. cGLP Lab, Vapi
Data Integrity
21 CFR Part 11 Compliant
Regulatory Overview & Key Technical Definition

About Elemental Impurities (ICH Q3D)

Satvam Research provides trace elemental impurities screening conforming to ICH Q3D, USP <232>/<233>, and FDA guidelines. Utilizing our Lab India ICP 5000DV dual-view plasma emission spectrometer coupled with the CEM MARS 6 closed-vessel microwave digestion system, we quantify Class 1, Class 2A, Class 2B, and Class 3 elements at sub-ppb levels across pharmaceutical APIs, excipients, and packaging materials.

Testing Scope

Key Capabilities & Parameters

Conducted strictly in accordance with official compendial monographs and validated study protocols

Screening and quantitative determination of Class 1 elements: As, Cd, Pb, Hg
Quantitation of Class 2A elements: Co, Ni, V
Quantitation of Class 2B elements: Tl, Au, Pd, Ir, Os, Rh, Ru, Se, Ag, Pt
Quantitation of Class 3 elements: Li, Sb, Ba, Mo, Cu, Sn, Cr
Matrix spike recovery and validation conforming to USP <233>
Elemental profiling for drug substances, excipients, water, and packaging materials
Infrastructure

Qualified Instrumentation Deployed

21 CFR Part 11 compliant hardware configurations governed by full IQ/OQ/PQ qualifications

ICP-OES Spectrometer - ICP 5000DV Dual-View
Lab India Instruments
Model: ICP 5000DV Dual-View

ICP-OES Spectrometer

Dual-view simultaneous multi-element detection with sub-ppb limit of detection.

Microwave Digestion System - MARS 6 High-Throughput Closed Vessel
CEM Corporation
Model: MARS 6 High-Throughput Closed Vessel

Microwave Digestion System

Complete matrix breakdown and total recovery of volatile trace elements.

Compliance Architecture

Regulatory Framework & Standards

Testing protocols aligned with domestic and global health authority requirements

ICH Q3D Guideline for Elemental Impurities
USP <232> Elemental Impurities – Limits
USP <233> Elemental Impurities – Procedures
Ph. Eur. 5.20 Elemental Impurities
USFDA Guidance on Elemental Impurities in Drug Products
Logistics

Sample Submission Guidelines

Dispatch specifications for guaranteed analytical integrity

Minimum Sample Qty
15 - 25 g of homogenous solid or 50 mL liquid sample.
Container Type
Trace-metal-free HDPE or PTFE containers; no borosilicate glass for boron/silicon.
Storage Condition
Room temperature (15-25°C) in sealed double polyethylene bags.
Standard TAT
5 - 7 business days
Special Instruction: Specify suspected catalyst metals and expected target concentrations.
Frequently Asked Questions

Technical & Regulatory Inquiries

Why is microwave digestion superior for elemental analysis?

Open-beaker acid digestion can lead to volatile element loss (such as Arsenic, Mercury, and Osmium) and incomplete digestion. Closed-vessel microwave digestion under high temperature and pressure achieves complete dissolution of complex matrices with zero volatile loss.

Which elemental classes are mandatory for testing?

Class 1 elements (As, Cd, Pb, Hg) are mandatory across all drug delivery routes due to high human toxicity. Class 2A (V, Co, Ni) must be assessed for oral and parenteral products, while other classes depend on manufacturing catalysts and excipient risk assessments.

Initiate Your Elemental Impurities (ICH Q3D) Testing

Contact our analytical laboratory in Vapi to review your protocol requirements, discuss sample shipping, or schedule a facility audit.

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