Drug products and drug substances are analyzed routinely as per the latest pharmacopeia (USP, BP, EP, IP. JP) or customer specified procedures and specifications including the following tests:
- Routine Physico Chemical analysis
- Microbiological analysis (MLT, detection of specified pathogens, Bacterial Endotoxin Test)
- Identification of microorganisms as per USP <1116>.
- Mineral Trace and Heavy Metals by ICP-MS in line with USP <232>, <233> & <2332>.
- Organic Volatile Impurities and Residual solvents as per USP <467>.
- Residual genotoxic impurity profiling.
- Vitamin Assays
- Amino Acid Analysis
- Dissolution profiling
In order to align with the regulatory requirements as per USP <232>&<233>, ICH guidelines and EP 5.2. We are providing services for Heavy metal analysis by ICP-MS.
- Semi-quantitative screening of the periodic classification of elements (screening of 50 elements).
- Characterisation and quantification of mineral impurities.
- Development and validations of methods according to the following guidelines: ICH Q3D, Pharm. Eur5.2 and USP 232 & 233.
Any pharmaceutical product manufacturer requires a quality control which is one of the foremost requisite with regard to regulatory compliances. A significant portion of the cGMP regulations (21 CFR PART 211) and all pharmacopeia methods such as USP, IP, EP, JP, BP and In-house methods pertain to the quality control testing of products. Chandra Labs provides expert analytical services in all areas of testing from raw materials, excipients, APIs, Bulk drugs, intermediates to finished products. Chandra Labs sophisticated pharmaceutical testing lab operates as an extension to your QC and Analytical R&D laboratories.
Data Integrity is being handled in compliant with CFR 211 regulations subsections (a) to (g). All the data acquisition systems are linked through ECM software ensuring data security from generation till archival of electronic data.
Our team of well-trained and highly qualified professionals performs testing for all phases of product development from conception to market. Whether our customer needs raw material or finished product testing, wet chemistry or instrumental analysis or release testing, Chandra labs has the necessary experience and knowledge to deliver timely and accurate results in compliance with ISO 17025 standards.