Our Analytical Capabilities
- Nitrosamine impurities testing (NDMA, NDEA, NEIPA, NDIPA, NDBA, NMBA) using LC-MS/MS as per USFDA & MHRA
- NDSRIs testing and validation as per EMA & USFDA guidelines
- Extractables and Leachables (E&L) studies with toxicological risk assessment (USP)
- ICH carcinogenic impurity characterization
- Impurity identification, isolation, and characterization including nitrosamines
- ICP & ICP-MS studies for elemental impurity analysis
- Comparative dissolution studies
- Bioanalytical method development and validation
- API characterization and analytical evaluation
- Analytical method development
- Excipient compatibility studies
- Method validation as per ICH and USP guidelines
- IVRT & IVPT studies (in-vitro release and permeation testing)
- Iron carbohydrate complex characterization
- Liposomes & nanosomes characterization
What types of impurities do you test for?
We test for a wide range of impurities including nitrosamines (NDMA, NDEA, etc.), NDSRIs, elemental impurities, and ICH-defined carcinogenic compounds.
Are your testing methods compliant with global regulations?
Yes, our testing and validation approaches are aligned with USFDA, EMA, MHRA, ICH, and USP guidelines to ensure regulatory acceptance.
Do you provide method development and validation services?
We offer comprehensive analytical and bioanalytical method development and validation tailored to specific product and regulatory requirements.
Can you support complex formulations and advanced drug delivery systems?
Yes, we specialize in characterization of complex formulations including liposomes, nanosomes, and iron carbohydrate complexes.
Do you support extractables and leachables studies with risk assessment?
We conduct complete E&L studies along with toxicological risk assessment to evaluate product safety and packaging compatibility.
Precision Testing. Confident Outcomes.
Accurate analytical testing is essential to ensure product quality, safety, and regulatory compliance across pharmaceutical and cosmetic development. At Accuprec, we combine advanced instrumentation with deep scientific expertise to deliver reliable, reproducible, and audit-ready results.
From complex impurity profiling and nitrosamine assessment to method development and formulation studies, our solutions are designed to support faster approvals and confident decision-making at every stage.
Our Approach to Accurate & Compliant Testing
Requirement Understanding
We begin by understanding your product, testing requirements, and regulatory objectives to define a clear analytical strategy.
Method Development & Planning
Our team develops and optimizes analytical methods, ensuring alignment with ICH, USP, and global regulatory standards.
Testing & Analysis
Samples are tested using advanced instrumentation such as LC-MS/MS, ICP-MS, and other validated techniques for accurate results.
Reporting & Compliance Support
We deliver detailed, audit-ready reports and provide support for regulatory submissions and compliance requirements.
