Drugs & Pharmaceuticals

Drugs and Pharmaceuticals are essential commodities for patients, who do fight against diseases. Quality of Drugs and Pharmaceuticals is utmost requirement to be maintained without any compromise. Quality is a characteristic of a medicine which is controlled and monitored using highly sensitive and precise advance analytical techniques handled by highly skilled & competent people.

Interstellar Testing Centre Pvt. Ltd., (ITC Lab) has been supporting its business partners since 1988 and upgrading its analytical infrastructure time to time including retiring the Instruments.

Currently, ITC Lab is supporting in Quality Control, Analytical Method Development, Method Verification and Validation. ITC Lab also supports for Method transfer to manufacturing units, if method is developed & validated for them and method transfer from Manufacture’s site to ITC Lab.

ITC Lab is offering high end studies in addition of Assay, Related Substances, Volatile Organic impurities etc) as follows:

1. Estimation of Nitrosamine impurities (NDMA, NDEA, NDIPA, NEIPA, NDBA, NMBA and NMPA) in Drugs & Pharmaceuticals and Packaging materials. Lab is also estimating Nitrosamine impurities in Potable/Process water for NDMA, NMEA, NDEA, NDPA, NDBA, NPYR & NPIP at ppt level.
2. Evaluation of Extractables (USP <1663>), which may migrate to Drug products from Container and closure System. These may be elemental impurities {ICH Q3D/USP 232}, Volatile, Semi volatile organic impurities and Non-volatile organic impurities using ICPMS, GC/MS-MS and LC/MS-MS respectively.
3. Evaluation of Leachables (USP <1664>); these are the chemical compounds which migrate from the container closure system, packaging material, or medical device into the drug product over time under normal storage conditions or during the product’s intended use.
4. Cross contamination studies; Scientists at ITC Lab are working closely with manufacturing units of Drugs and Pharmaceuticals to address and ensure there is no any Chemical and Microbial contamination of other product or from Environment using Surface swabs and Air samples.
5. Elemental impurities {ICHQ3D and USP<232>}; ITC Labs is providing this support to API manufactures, Drug Products manufactures, Cosmetic Products manufactures and AYUS Drugs manufactures according to their specific requirements using LC-ICP-MS, ICP-MS, ICP-OES and AAS.
6. Haemodialysis water: ITC Labs is only the lab in this region to perform complete testing of water to be used in Haemodialysis to meet the requirement of ISO 23500-3 for Chemical (Anions & Cations, Inorganic Elements) and Microbial contamination (BET and TVAC).
7. Microbiological Support; ITC Lab is providing support in 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> Microbial assay (USP<81>)