Elemental Analysis – Ensuring Purity,
Safety & Regulatory Compliance in
Pharmaceuticals
Elemental analysis is a critical quality control step in the pharmaceutical industry to detect and quantify trace metals and elemental impurities that may be introduced during raw material sourcing, manufacturing, or packaging. These impurities, if present above permissible limits, can pose significant safety risks and impact product efficacy. At SIMA LABS, we provide precise and reliable elemental analysis in compliance with ICH Q3D, USP <232>/<233>, Ph. Eur., and other global pharmacopeial guidelines. Our advanced instrumentation enables detection at ultra-trace levels, ensuring products meet stringent regulatory requirements and are safe for patient use.
Why Choose SIMA LABS for Elemental Analysis Testing?
- NABL Accredited & Regulatory-Compliant Testing – Fully aligned with ICH Q3D, USP, and Ph. Eur. standards.
- Advanced Detection Technologies – ICP-MS, ICP-OES, and AAS for accurate multi-element analysis.
- Comprehensive Scope – Testing for toxic elements (As, Cd, Hg, Pb), catalyst residues (Pt, Pd, Rh), and other metal impurities.
- Applicable to All Pharma Materials – APIs, excipients, finished dosage forms, intermediates, and packaging leachables.
- Ultra-Low Detection Limits – Ensuring compliance with global safety thresholds.
- Fast Turnaround & Expert Support – Timely reports with clear data interpretation for regulatory submissions.
35+ Years of SIMA LABS– Elemental Analysis Testing You Can Trust
Because tiny tummies deserve the purest start.
SIMA LABS is NABL accredited and approved for elemental analysis in pharmaceutical products, ensuring compliance with FSSR, BIS, and global pharmacopeial standards such as ICH Q3D, USP <232>/<233>, and Ph. Eur. Our approvals guarantee that results are legally valid for domestic regulatory submissions, export certification, and international market entry.
We provide comprehensive multi-element impurity testing for pharmaceuticals using advanced analytical techniques to ensure product safety and compliance.
Scope of Testing:
Products Covered: APIs, excipients, finished dosage forms, intermediates, and packaging leachables/extractables.
Elements Tested:
Class 1 Toxic Elements – Arsenic (As), Cadmium (Cd), Mercury (Hg), Lead (Pb)
Class 2A & 2B Elements – Cobalt (Co), Vanadium (V), Nickel (Ni), Thallium (Tl), Palladium (Pd), Platinum (Pt), Rhodium (Rh), Ruthenium (Ru), Osmium (Os), Iridium (Ir)
Class 3 Elements – Less toxic metals monitored for quality purposes
Technology Used:
ICP-MS (Inductively Coupled Plasma Mass Spectrometry)
ICP-OES (Inductively Coupled Plasma Optical Emission Spectroscopy)
GFAAS / CV-AAS (Graphite Furnace & Cold Vapor Atomic Absorption Spectroscopy)
Regulatory Compliance:
ICH Q3D guidelines for elemental impurities
USP <232>/<233> and Ph. Eur. 5.20 standards
BIS & FSSR safety limits
Our validated methods ensure ultra-trace detection, accurate quantification, and regulatory-ready reports for global pharmaceutical compliance.
Trusted by leading brands
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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+(91)-(11)-43854300