Reliable medicine is a prerequisite for the well-being of individuals and the success of the healthcare industry. Ensuring the quality, safety, efficacy, and reliability of pharmaceutical drugs helps manufacturers build trust while consumers seek healing and a cure.
Qualitek Labs is one of the most reliable drug testing laboratories with comprehensive testing facilities. Our laboratories are designed to perform mandatory regulatory requirements and industry standards. We have the most modern equipment in our labs to carry out updated methodologies that deliver accurate results for drug testing.
Comprehensive Pharmaceutical Testing Services
The drug testing labs in Qualitek Labs have dedicated wings for specialised testing of drug products and identification of active pharmaceutical ingredients (APIs). Our test methodologies are in accordance with national and international regulatory standards.
The following are the wide range of drug tests we conduct at our laboratories:
Dissolution, HPLC & Assay Testing
- Dissolution Testing: This test helps us understand the rate at which a drug dissolves in a solution, facilitating bioavailability studies.
- High-Performance Liquid Chromatography (HPLC): This is an advanced testing methodology used for related substance analysis, assay, and dissolution studies to determine product purity and stability.
- Liquid Chromatography with Mass Spectroscopy (LC-MS/MS): Latest testing method in the industry for identifying and quantifying impurities, including Nitrosamine impurities.
- We perform the following Nitrosamine tests at our labs:
- – N-nitrosodimethly amine (NDMA)
- – N-Nitrosodiethylamine (NDEA)
- – N-Nitrosodibutyl amine (NDBA)
- – N-Nitrosodiisopropylamine (NDIPA)
- – N-Nitrosomethylpropylamine (NMPA)
- – N-Nitrosoisopropylethylamine (NEIPA)
- – N-Nitrosomethylaminobutyric acid (NMBA)
- – N-NirosoDiclofenac
- – 1-Methyl-4-Nirosopiperazine (NMPIPZ)
- – N-Nitrosodrozolamide
- – N-methyl-N—nitrosopiperzine (NMPP)
- – N-nitrosopiperdine
- – N-Nitrosopyrrolidine
- – N-nitromethylethlamine (NMEA)
- -N-Nitroso Aceclofenac
Impurity Profiling & Residual Solvents Analysis
Organic Impurities Testing:
- Residual solvents analysis using Gas Chromatography (GC-MS/MS).
- Identification and quantification of Nitrosamine impurities.
Elemental Impurities Testing
- ICP-MS (Inductively Coupled Plasma Mass Spectrometry)
- ICP-OES (Inductively Coupled Plasma Optical Emission Spectrometry)
- AAS (Atomic Absorption Spectroscopy)
- IC (Ion-Exchange Chromatography)
Particle Size Analysis
From keeping us alive to keeping the fire up, air is one of the most necessary elements of the Earth. With every passing day, we are witnessing a drastic drop in the quality of air, leading to severe health problems. Our labs provide reliable monitoring of air to understand the quality variations.
Here are the tests we carry out in our labs:
Extractable & Leachable Studies
One of the biggest threat pharmaceutical manufacturers faces is leaching where contaminants from packaging materials and production equipment migrate into drug formulations. We have the facility to carry forward the following test to determine and prevent it:
- Chemical Analysis
- Elemental Impurities Testing
- Organic & Non-Organic Impurities Analysis
Microbiological Testing for Contamination & Pathogens
Microbial contamination is the biggest threat to medicine quality and standards as it can compromises drug safety. At Qualitek Labs, we have the facility to perform comprehensive microbiology tests such as:
- Microbial Limit Test
- Bacterial Endotoxin Test
- Preservative Efficacy Testing
- Disinfectant Efficacy Test
- Sterility Testing
- Vitamin B12 Assay
- Antimicrobial & Antibiotic Assay
- Environmental Monitoring
- Growth Promotion Testing
- Microbial Kill Rate Study
- In-use Stability Studies
Compliance with Pharmacopoeia Standards
Pharmacopia is legalised documents that determine the quality requirement and standard regulation for medicines. Our drug testing laboratories ensure compliance of your medicines 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
Why Choose Qualitek Labs for Drug Testing?
We are packed with instruments such as HPLC, GC-MS/MS, ICP-MS, and LC-MS/MS to perform advanced tests and provide precise and accurate testing results. In every efforts, we strive to offer a full spectrum of testing services covering everything from impurity profiling to packaging testing . With eLABSS LIMS as our operational software, we focus on accuracy, compliance, and innovation for pharma testing services.
FAQ
We at Qualitek Labs are very keen on providing an all-encompassed drug testing service to our consumers. Our tests include raw materials, active pharmaceutical ingredients (APIs), bulk drugs, and finished drug products.
We have a preset rule on maintaining utmost discipline in conducting analytical tastings to ensure the abidance of international pharmacopeial standards and guidelines. Equipped with advanced instrumentation and maintained by trained experts, we follow USP, EP, and ICH.