Drugs & Pharmaceuticals

Drugs and pharmaceuticals are essential commodities for our health and well-being. Effective drug and pharmaceutical testing is indispensable to ensure quality control and the safety of the consumers. For any medicine to be potent in battling a disease, its manufacture must be closely monitored and quality strictly controlled. This is achieved under the watchful eyes of skilled professionals who utilize their analytical techniques and high-quality lab testing equipment to achieve the desired results.

Why Choose ITC Labs for Drugs & Pharmaceutical Testing

What We Offer

ITC Labs is committed to delivering the highest quality of drug and pharmaceutical testing services to its beneficiaries. We are skilled in our work at Assay, Related Substances, Volatile Organic impurities, etc. Listed below are some of the other high-end studies that we offer.

1. Estimation of Nitrosamine impurities

Drugs, Pharmaceuticals and their Packaging materials are tested for the presence of NDMA, NDEA, NDIPA, NEIPA, NDBA, NMBA and NMPA. ITC Labs also offers its services in estimating Nitrosamine impurities in Potable/Process water for NDMA, NMEA, NDEA, NDPA, NDBA, NPYR & NPIP at ppt level.

2. Evaluation of Extractables (USP <1663>)

These may migrate to Drug products from Containers and closure Systems. They may be elemental impurities {ICH Q3D/USP 232}, Volatile, Semi-volatile Organic Impurities and Non-volatile Organic Impurities. These are evaluated using ICPMS, GC/MS-MS and LC/MS-MS, respectively.

3. Evaluation of Leachables (USP <1664>)

These are chemical compounds that migrate into the drug or pharmaceutical product over time under normal storage conditions or during the product’s intended use. They get leached from the container closure system, packaging material, or medical device into the product.

4. Cross-contamination Studies

Scientists at ITC Labs work closely with the manufacturing units of Drugs and Pharmaceuticals to ensure a stop to cross-contamination. Using surface swabs and air samples, these studies guarantee that there is no Chemical and Microbial contamination of the product from its environment.

5. Elemental Impurities {ICHQ3D and USP<232>}

ITC Labs provide this support to API manufacturers, Drug & Pharmaceutical Product manufacturers, Cosmetic Product manufacturers and AYUSH Drugs manufacturers according to their specific requirements. These tests are carried out using LC-ICP-MS, ICP-MS, ICP-OES and AAS.

6. Hemodialysis Water

ITC Labs is the only lab in this region to perform complete testing of water intended to be used in Hemodialysis. It is duly tested to meet the requirements of ISO 23500-3 for Chemical (Anions & Cations, Inorganic Elements) and Microbial contamination (BET and TVAC).

7. Microbiological Support

ITC Labs is equipped to carry out the following tests among others: Microbial Limit Test (MLT) Validation (USP <61> & <62>), Preservative Efficacy Test (PET) Studies (USP <51>), Bacterial Endotoxin Test (BET) (USP <85>), Sterility (USP <71>) and Disinfectant Efficacy Test (USP <1072>), and Microbial assay (USP<81>).

How We Work

Integrity and security are the hallmarks of our work at ITC Labs. Our test data is securely managed through two online data collection platforms and a cloud-based Laboratory Information Management System (LIMS). At ITC Labs, we employ advanced analytical techniques and high-end equipment to deliver reliable results for our drug and pharmaceutical studies.