During Analysis of residual solvents found An unknown peak so my question this which guideline to be used for investigation And what is limit of unknown peak in PPM And how is calculated
Hey there Shivaya shambhu Shiv! When it comes to investigating unknown peaks, especially in residual solvents and related substances, the go-to guideline is typically outlined in pharmacopeias like USP, EP, or JP. These guidelines offer structured approaches for the identification and evaluation of unknown peaks in chromatographic analysis.
As for the limit of unknown peaks in parts per million (PPM), it varies depending on the specific regulatory requirements or industry standards applicable to your analysis. However, a common practice is to set acceptance criteria based on the sensitivity of the analytical method and the potential impact on product safety and quality.
Calculating the concentration of an unknown peak in PPM involves comparing its peak area or height to that of a known standard or internal standard. By relating these measurements to the sample concentration, you Shivaya shambhu Shiv can determine the PPM value.
For a more precise answer tailored to your Shivaya shambhu Shiv specific situation, it's best to consult the relevant regulatory guidelines and standards applicable to your industry or region. If you Shivaya shambhu Shiv need further assistance or clarification, feel free to ask!