Arka Labs

Dear Connects, Our Director DR Madhu Sudhan Reddy Yadamakanti is traveling in USA from 12th to 26th of October. Please message here in case you want to engage in any Business meeting with him.

Our Bell Ganeshaa..🙏🙏

@iphex Noida

Arka Labs offers #LC-MS studies #LC-MS is indeed a valuable tool for the detection and quantification of #nitrosamine impurities in drug substances, especially in the context of recent concerns about nitrosamine impurities in pharmaceuticals. #Nitrosamines are a group of potentially carcinogenic compounds that can form as impurities in certain drug substances or during the manufacturing process. Regulatory authorities, such as the #FDA and #EMA, have issued guidelines and requirements for the evaluation and control of nitrosamine impurities in pharmaceutical products. Here's how #LC-MS can be used for the detection of nitrosamine impurities in drug substances: 1. **Selective and Sensitive Detection**: LC-MS offers high selectivity and sensitivity, allowing for the detection of nitrosamine impurities at very low levels in complex matrices. 2. **Identification and Confirmation**: LC-MS can be used to identify and confirm the presence of specific nitrosamine impurities by comparing their mass spectra and retention times with reference standards. 3. **Quantification**: LC-MS can quantify the levels of nitrosamine impurities present in drug substances, providing accurate measurements for regulatory compliance. 4. **Method Development**: LC-MS methods need to be developed and validated for the analysis of nitrosamine impurities. This involves optimizing the chromatographic separation, mass spectrometric conditions, and sample preparation techniques. 5. **Regulatory Compliance**: LC-MS data can be used to demonstrate compliance with regulatory requirements regarding the control of nitrosamine impurities in pharmaceutical products. By utilizing LC-MS for the detection of nitrosamine impurities in drug substances, pharmaceutical companies can ensure the safety and quality of their products and comply with regulatory guidelines. LC-MS is a versatile analytical technique that plays a crucial role in the analysis of impurities and contaminants in pharmaceuticals.

Dr. Someshwar Komuravelly Satwik Reddy Legala Prathyusha Vallabhaneni