Raw Material Testing – Ensuring
Quality from the Very First Step
Raw material testing is the foundation of pharmaceutical quality assurance, ensuring that every ingredient used in manufacturing meets identity, purity, potency, and safety requirements. Contaminated or substandard raw materials can compromise product quality, regulatory compliance, and patient safety. At SIMA LABS, we conduct comprehensive raw material testing for active pharmaceutical ingredients (APIs), excipients, intermediates, and packaging materials in strict accordance with USP, EP, BP, IP, and ICH guidelines. Our testing covers chemical, physical, and microbiological parameters, using advanced analytical techniques to verify compliance before materials enter the production process.
Why Choose SIMA LABS for Raw Material Testing?
- Full Regulatory Compliance – Testing as per pharmacopeial and ICH requirements.
- Comprehensive Scope – APIs, excipients, solvents, intermediates, and packaging materials.
- Advanced Technology – HPLC, GC, FTIR, ICP-MS, UV-Vis, and microbiological testing facilities.
- GMP-Aligned Processes – Supporting batch release and supplier qualification.
- Expert Analysis – Highly trained chemists and microbiologists ensuring accurate, reliable results.
- Risk Mitigation – Prevents quality failures and ensures safe, compliant manufacturing.
35+ Years of SIMA LABS – Raw Material Testing You Can Trust
SIMA LABS is NABL accredited and approved under FSSR and BIS for comprehensive raw material testing in compliance with USP, EP, BP, IP, and ICH guidelines. Our testing protocols are GMP-aligned, ensuring that all incoming raw materials meet identity, purity, potency, and safety standards before use in pharmaceutical manufacturing.
We offer end-to-end testing services for pharmaceutical raw materials to safeguard product quality from the start.
Scope of Testing:
Materials Covered:
Active Pharmaceutical Ingredients (APIs)
Excipients
Solvents & intermediates
Packaging materials in contact with drug products
Parameters Tested:
Chemical: Assay, impurity profiling, heavy metals, residual solvents, elemental analysis
Physical: Particle size, moisture content, bulk density, appearance
Microbiological: Total microbial count, specified pathogens, endotoxins (for sterile materials)
Techniques Used:
HPLC, GC, FTIR, ICP-MS, ICP-OES, UV-Vis spectroscopy
Microbiological testing in GMP-grade cleanrooms
Regulatory Compliance:
USP, EP, BP, IP standards
ICH Q7 & Q3A/B guidelines
GMP requirements for raw material release
With cutting-edge instrumentation, stringent quality systems, and expert analysts, SIMA LABS ensures that only safe, compliant, and high-quality raw materials enter your production line.
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.
Let’s Connect – Book Your Appointment Today!
Or call us now
+(91)-(11)-43854300