Inorganic Impurities Testing –
Ensuring Pharmaceutical Purity
& Safety
Inorganic impurities, including residual metals, salts, and other non-organic contaminants, can be introduced into pharmaceutical products during manufacturing, raw material sourcing, or through equipment and packaging interactions. These impurities can affect drug stability, efficacy, and patient safety. At SIMA LABS, we conduct comprehensive inorganic impurities testing in compliance with ICH Q3D, USP <232>/<233>, and Ph. Eur. guidelines. Using advanced analytical techniques, we detect and quantify toxic heavy metals, catalyst residues, and other inorganic contaminants at ultra-trace levels, ensuring products meet global regulatory requirements and maintain the highest quality standards.
Why Choose SIMA LABS for Inorganic Impurities Testing?
- NABL Accredited & Pharmacopeia-Compliant – Fully aligned with ICH Q3D, USP, BP, and EP standards.
- Comprehensive Impurity Profiling – Includes Class 1 toxic elements, Class 2 catalyst residues, and Class 3 metals.
- Advanced Instrumentation – ICP-MS, ICP-OES, AAS, and validated methods for accurate results.
- Applicable to All Pharma Materials – APIs, excipients, finished dosage forms, intermediates, and packaging leachables.
- Ultra-Low Detection Limits – Ensuring compliance with strict international limits.
- Regulatory-Ready Reports – Accepted by authorities for domestic submissions and exports.
35+ Years of SIMA LABS – Inorganic Impurities Testing You Can Trust
SIMA LABS is NABL accredited and approved under FSSR and BIS for the detection and quantification of inorganic impurities in pharmaceutical products. All testing is conducted in accordance with ICH Q3D, USP <232>/<233>, Ph. Eur., and other global pharmacopeial standards, ensuring results are valid for regulatory submissions, quality audits, and international market approvals.
We provide precise and reliable testing for inorganic contaminants to ensure pharmaceutical products are safe, compliant, and of the highest quality.
Scope of Testing:
Materials Covered: APIs, excipients, finished dosage forms, intermediates, and packaging leachables/extractables.
Impurities Tested:
Class 1 Toxic Elements: Arsenic (As), Cadmium (Cd), Mercury (Hg), Lead (Pb)
Class 2A & 2B Elements: Cobalt (Co), Nickel (Ni), Vanadium (V), Palladium (Pd), Platinum (Pt), Rhodium (Rh)
Class 3 Elements: Less toxic metals monitored for quality assurance
Technology Used:
ICP-MS (Inductively Coupled Plasma Mass Spectrometry)
ICP-OES (Inductively Coupled Plasma Optical Emission Spectroscopy)
AAS (Atomic Absorption Spectroscopy) – Graphite Furnace & Cold Vapor methods
Regulatory Compliance:
ICH Q3D Guidelines for elemental impurities
USP <232>/<233> and Ph. Eur. 5.20
BIS & FSSR safety standards
With state-of-the-art technology, validated methods, and expert analysts, SIMA LABS ensures accurate inorganic impurity profiling for complete pharmaceutical quality assurance.
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our customers are the driving force behind our growth and innovation
Precision. Compliance. Innovation
Our Expertise
At Sima Labs, we specialize in advanced analytical testing, regulatory compliance, and quality assurance across the food, pharmaceutical, and environmental sectors—delivering reliable results with international standards and technical excellence.
Residue Analysis
SIMA LABS offers residue testing and compliance with ELV, RoHS, REACH, and EN71 standards
Microbiological Analysis
SIMA LABS provides microbiological testing and indoor air quality monitoring.
Molecular Biological Analysis
SIMA LABS offers GMO, allergen, pathogen testing, event identification, and pharma analysis for safety and compliance.
Method Development and Validation Studies
SIMA LABS provides stability testing, drug analysis, quality checks, lab consultancy, training, and R&D support.
Environment Monitoring
SIMA LABS offers environmental testing for pollutants, gases, and air quality monitoring.
Get In Touch
At SIMA LABS, we’re proud to offer our expertise in analysis and research to help you find the right solutions.
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