Drugs & Pharmaceuticals Testing Laboratory

In healthcare industry, ensuring the safety, efficacy, and quality of pharmaceutical products is a critical requirement. At ITC Labs, we offer comprehensive pharmaceutical testing services designed to meet stringent regulatory requirements and industry standards. Our pharmaceutical testing labs are equipped with advanced technology and methodologies to deliver reliable and accurate testing solutions for drugs testing and pharmaceutical product testing.

Comprehensive Pharmaceutical Testing Services

Our pharmaceutical analysis lab specialises in testing drug products and active pharmaceutical ingredients (APIs) to ensure compliance with national and international regulations.

We conduct a wide range of pharmaceutical analysis testing, including:

1. Method Development & Validation — HPLC

At our pharmaceutical testing laboratory, we offer comprehensive High-Performance Liquid Chromatography (HPLC) method development and validation services designed to meet stringent global regulatory requirements. Backed by advanced instrumentation and a highly experienced scientific team, we develop robust, reliable, and reproducible analytical methods tailored to diverse pharmaceutical matrices, including Active Pharmaceutical Ingredients (APIs), finished formulations, and excipients.
Within this broad capability, our services are structured around three core areas of pharmaceutical method validation:
  • Assay
  • Related Substances
  • Dissolution

2. MD Validation by GC & GC-MS

We offer advanced Gas Chromatography (GC) and Gas Chromatography–Mass Spectrometry (GC-MS) method development and validation services for volatile and semi-volatile compounds. Our capabilities are particularly critical for identifying trace-level impurities and ensuring compliance with regulatory safety limits.
Our GC and GC-MS validation capabilities cover:
  • Assay
  • Related Substances
  • Residual Solvents

3. Genotoxic Impurities

GMP-compliant testing for genotoxic and mutagenic impurities across pharmaceutical raw materials, intermediates, APIs, and finished drug products. We employ advanced techniques such as GC-MS/MS and LC-MS/MS to detect impurities at extremely low levels (ppm to ppb), ensuring compliance with global guidelines such as ICH M7.
Nitrosamines & NPSRI’s by GCMS & LCMS
We offer dedicated nitrosamine and NSRI testing using highly sensitive GC-MS and LC-MS/MS platforms, developed and validated to meet the specific detection requirements outlined in current regulatory guidance.

4. Elemental Impurities by ICRMS/OES/AAS

We provide comprehensive elemental impurities testing for pharmaceutical raw materials, drug substances, excipients, and finished drug products.

5. Method Development & Validation by IC

We provide Ion Chromatography (IC) based method development and validation services for the detection and quantification of ionic species in pharmaceutical raw materials, drug substances, excipients, and finished drug products.
Our IC method development and validation services are structured around three core areas, each addressing a distinct category of ionic analyte.
  • Anionic
  • Cationic
  • Traced Impurities

6. Validation Particle Size Analyser

We develop and validate particle size methods for pharmaceutical raw materials, APIs, excipients, and finished products. Depending on the nature of the material and the demands of the formulation, particle size measurement can be approached via two established techniques, each with its own method development considerations and validation requirements:
  • Wet Method
  • Dry Method

7. MD Method Validation HPTLC

We provide High-Performance Thin Layer Chromatography (HPTLC)-based method development and validation services for qualitative and quantitative analysis of pharmaceutical substances. HPTLC offers a cost-effective and efficient alternative for screening, identification, and fingerprint analysis, particularly for complex formulations and herbal products. Our methods are developed to ensure accuracy, repeatability, and regulatory compliance

8. Extractable & Leechable

At ITC Labs, we offer comprehensive extractables and leachables (E&L) studies to assess the potential migration of chemical compounds from packaging materials, container closure systems, medical devices, etc into pharmaceutical products.

9. Microbiological Testing for Contamination & Pathogens

Microbial contamination can compromise drug safety. Our pharmaceutical testing lab offers comprehensive microbiology testing, including
  • Microbial Limit Test
  • Bacterial Endotoxin Test
  • Preservative Efficacy Testing
  • Disinfectant Efficacy Test
  • Sterility Testing
  • Vitamin B12 Assay
  • Antimicrobial Assay
  • Antibiotic Assay
  • Antimicrobial Activity MIC Determination
  • Environmental Monitoring
  • Growth Promotion Testing
  • In-use Stability Studies

10. Compliance with Pharmacopoeia Standards

Our pharmaceutical analysis lab ensures compliance with national and international pharmacopoeias, including:
  • Indian Pharmacopoeia (IP)
  • United States Pharmacopoeia (USP)
  • European Pharmacopoeia (EP)
  • British Pharmacopoeia (BP)
  • International guidelines for Nitrosamines detection and control
placebo effect preparing drugs placebo controlled medical therapy scientific study 1 scaled

Why Choose ITC Labs for Drugs & Pharmaceutical Testing?

At ITC Labs , we take pride in offering top-tier pharmaceutical testing services backed by cutting-edge technology and a team of experts dedicated to quality and compliance. Our commitment to excellence makes us a trusted pharmaceutical testing lab for businesses across the industry. We leverage advanced analytical instruments such as HPLC, GC-MS/MS, ICP-MS, and LC-MS/MS to ensure precise and accurate testing results. These technologies help in detecting impurities, ensuring drug stability, and meeting stringent regulatory requirements, making us a reliable partner for pharmaceutical product testing.

We offer a full spectrum of testing services, from drugs testing to pharmaceutical product testing, covering everything from impurity profiling to microbiological analysis (redirect to microbiology page). Our pharmaceutical analysis lab provides end-to-end solutions to help manufacturers maintain the highest standards of quality and safety.

Our team of experienced scientists and analysts is committed to delivering high-quality pharmaceutical testing services with precision and reliability. Their expertise ensures that every test meets industry standards, providing manufacturers with confidence in their product quality.

With a focus on accuracy, compliance, and innovation, ITC Labs is the preferred choice for pharma testing services. Contact us today to learn more about how we can support your pharmaceutical testing needs.

FAQ

ITC Labs tests a wide range of pharmaceutical products, including raw materials, active pharmaceutical ingredients (APIs), bulk drugs, and finished drug products. Our services cover various dosage forms and therapeutic categories.
We adhere to international pharmacopeial standards and guidelines, including those from the USP, EP, and ICH. Our laboratory is equipped with advanced instrumentation, and our staff is trained to perform tests in compliance with these standards.
Nitrosamine impurities are potential carcinogens that can be present in pharmaceutical products. Testing for these impurities is crucial to ensure product safety and regulatory compliance.
Yes, we provide tailored testing services to meet the specific needs of our clients. Our team works closely with clients to develop and validate methods suitable for their unique requirements.
You can request a quote by contacting us through our website (redirect to contact us page) or reaching out to us via call or mail. Our team will reach out to you to understand your testing needs and provide a detailed quote.

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    Declaration

    ITC Labs, the abbreviated name for Interstellar Testing Centre Private Limited, is an entirely independent and privately held analytical testing laboratory. The entity is not in any manner associated, affiliated, connected, endorsed, or sponsored by ITC Limited or any of its subsidiaries, associates, or group companies.

    All references to "ITC Labs" across this website, marketing material, or other communications are strictly intended to denote Interstellar Testing Centre alone. Any perceived similarity or reference to the mark “ITC” is purely coincidental and unintentional, and does not imply any commercial, legal, or corporate relationship with ITC Limited.

    This disclaimer is published voluntarily and in good faith to prevent confusion, and to unequivocally clarify that ITC Labs and ITC Limited are distinct and unrelated entities.

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