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Drugs & Pharmaceutical Testing
The pharmaceutical industry discovers, manufactures, and markets drugs and other pharmaceutical products for both clinical & consumer use and therefore plays an instrumental role in the healthcare sector. Before these drugs are available in the market as medicines, they undergo various analytical procedures to ensure their quality & efficacy.
Why Pharmaceutical Testing?
- To ensure consumers’ health & safety
- To validate drug quality & efficacy
- To avoid financial losses
- To comply with relevant laws, policies, standards, and regulations
CEGTH offers a complete solution for testing a wide range of pharmaceutical products starting from raw materials, excipients, Active Pharmaceutical Ingredients (APIs) to finished products & surgical items. The drug testing laboratory of CEG Test house has been approved by the State Drug Controller, Rajasthan to provide all the routine analysis as per the latest Pharmacopoeia (British Pharmacopoeia (BP), United States Pharmacopoeia (USP) and European Pharmacopoeia (EP) along with Indian Pharmacopoeia (IP)) or customer-specific procedures and specification. Our pharmaceutical testing lab is well equipped with a full array of analytical instrumentation meeting the 21 CFR part 11 requirements.
Our Comprehensive Range of Services under Testing for Drugs & Pharmaceutical Products Include
- Physicochemical Testing
- Related Substance/Impurity
- Uniformity of Content
- Stability Testing
- Method Validation
- Particulate Matter
- Microbiological Analysis (Sterility, BET)
Physicochemical testing is vital for verifying the quality of manufactured pharmaceutical products before a lot releases into the market. Under physical & chemical parameters, a drug should comply with the specifications mentioned in the latest pharmacopoeia determining its stability, solubility and in-vivo delivery. CEGTH’s drug testing laboratory is continuously delivering its best analytical services to meet manufacturing and quality standards. Some of the tests we perform under physicochemical testing are
- Optical Activity
- Spectral Analysis
Related Substance/Impurity Testing
The identification of pharmaceutical-related substances or impurities is an essential analytical activity in the drug development process. Pharmaceutical impurities can arise from different sources and significantly damage the purity, stability and safety of drug substances or finished drug products. These impurities/ related substances are generally present at very low levels. Consequently, sensitive and specific assay methods are required to quantify them and collate relevant information and facilitate efficient drug manufacturing processes. CEGTH’s drug testing laboratory proposes strategies for identifying such impurities/ related substances using sophisticated instruments such as:
Stability testing for drugs provides real-time response data of a drug substance or product in the given period under the influence of various environmental factors, such as temperature, humidity and light. This data helps to determine & validate the shelf life of pharmaceutical products with respect to their labeled specifications and recommended storage conditions. The drug testing laboratory of CEGTH is well-equipped to conduct stability testing, both real- time and accelerated, as per standards for a wide range of pharmaceutical products.
We have extensive experience in developing analytical methods using our sophisticated facility for pharmaceutical industries. Some of the applications are
- Quality Control of APIs, Starting Material, Intermediates, Finished Products, Impurities, and Degradation Products
- Stability Testing
- Identification and Characterization of Substances, Impurities and Degradation Products
- Microbiological Contaminants Determination
Validation of analytical protocols used in the pharmaceutical industry is critical to ensure that they are suitable, reproducible and ideal for the analysis being carried out. CEGTH’s drug testing laboratory has excelled in performing chemical and microbiological method validations across many industry techniques and product types. We are equipped to assist through the entire process comprising planning, preparation of the protocol, and analytical testing leading to the final project report. The vital areas in which we have expertise include
- Dissolution Profile Studies
- Product Formulation Methodologies
- Stability Testing as per ICH Guidelines
Microbial contamination is a significant risk within the pharmaceutical industry, having a potential impact on product integrity and patient safety. Through its well-equipped drug testing laboratory, CEGTH offers a comprehensive range of microbiological testing services compliant with GMP (Good Manufacturing Practices) requirements for pharmaceutical products, which include
- Sterility Tests
- Bacterial Endotoxin Tests (BET)
- Efficacy Tests
- Microbiological Assays in Antibiotics
CEGTH routinely performs assay testing in a variety of drug substances and products. Assay is an investigative method to determine the potency and purity of the analytes. The pharmaceutical testing lab of CEGTH is equipped with instruments like HPLC, UV-VIS spectrophotometers, etc. to provide time-bound accurate results to the clients.
Uniformity of Content
To check the purity of individual content of the active ingredient in each capsule or tablet, uniformity of content test parameters is analyzed as per the latest pharmacopoeia (BP, USP, IP, EP) protocols.
CEGTH’s Pharmaceutical Testing laboratory is well-versed in testing particulate matter ranging from <0.001 μm to >3,000 μm and uses a variety of techniques to develop and validate particle size methods. Particulate Matter Testing is predominantly vital for injectable solutions. It helps ensure the quality & accuracy of manufacturing processes and the hygiene factor of sample containers.
We Test all Product Categories, including API & Raw Materials, and Finished Products
|Gloves||Injections- Large Volume Parental & Small Volume Parental|
|BT (Blood Transfusion) Set|
Why Choose CEGTH?
CEGTH is committed to delivering excellence and precision in every result, with no compromise on quality and turnaround times. Our accredited drug testing laboratory is equipped with the most advanced analytical instruments to meet your pharmaceutical testing requirements efficiently, all under a single roof.
What truly sets us apart from others is our strong team of certified experts that offers reliable & trustworthy solutions for each of our clients.