Pharmaceutical Guidelines

SOP for HPLC Analysis and Documentation Standard operating procedure of Good Laboratory Practices for High Performance Liquid Chromatography. 1.0 OBJECTIVE To describe the procedure to be followed in HPLC analysis and documentation and to ensure that Good Laboratory Practices are followed in the  HPLC analysis. 2.0 SCOPE This SOP is applicable for the procedure to be followed in HPLC analysis and documentation and to ensure that Good Laboratory Practices are  followed in the HPLC analysis. 3.0 RESPONSIBILITY Officer/ Executive - Quality Control 4.0 ACCOUNTABILITY Manager – Quality Control. 5.0 PROCEDURE 5.1 There shall be sequence available for the analysis before startup on the instrument. 5.2 Mobile Phase 5.2.1 The mobile phase shall be prepared as per the composition described in the standard test procedure (STP) of respective sample. 5.2.2 The mobile phase container shall have labeling details as follows: Mobile phase : Product : Analysis of : ...

SOP for Guideline for System Suitability Test for HPLC Analysis Standard operating procedure to check the system suitability of HPLC. 1.0 Objective To provide the guideline for the system suitability test for HPLC analysis. 2.0 Scope This procedure is applicable for system suitability test required in high performance liquid Chromatographic analytical methods. 3.0 Responsibility 3.1 Doing: Technical Assistant/Executive 3.2 Checking: Executive /Manager 4.0 Accountability Head of the Department 5.0 Procedure 5.1 Follow system suitability procedure when system suitability test required in HPLC analytical method. 5.2 Perform a system suitability test of all HPLC instruments prior to use and after completion of testing. 5.3 The results of the different parameters which are included in system suitability should be within the limit as per the respective method of analysis. 5.4 Get the system suitability and chromatographs mention all the detail in respective product data...

SOP for Good Chromatography Practices : Pharmaceutical Guidelines SOP for Good Chromatography Practices Standard operating procedure for working with HPLC and GC analysis of pharmaceutical products in quality control laboratory. 1.0 OBJECTIVE To lay down a procedure for good chromatography practices. 2.0 SCOPE This SOP shall be applicable for HPLC & GC analysis performed in the quality control department. 3.0 RESPONSIBILITY QC officer / QC chemist 4.0 ACCOUNTABILITY HOD QC 5.0 PROCEDURE 5.1. System Suitability 5.1.2 Consider peak area/ peak height as a measure of response from the detector as specified in the method of analysis. While entering the system suitability data in the notebook, only average area and %RSD obtained from the summary report shall be entered. 5.1.3 When system suitability requirements are specified in the method of analysis, only those parameters will be considered. 5.1.4 When limit for %RSD of replicate injections of a standard solut...

SOP for Cleaning of High Performance Liquid Chromatography (HPLC) : Pharmaceutical Guidelines SOP for Cleaning of High Performance Liquid Chromatography (HPLC) Standard operating procedure to clean the High Performance Liquid Chromatography (HPLC). 1.0 OBJECTIVE To clearly lay down the procedure for cleaning. 2.0 SCOPE This procedure is applicable for of all high performance liquid chromatography installed in quality control laboratory. 3.0 RESPONSIBILITY 3.1 Doing: Technical Assistant 3.2 Checking: Executive/Manager 4.0 ACCOUNTABILITY Head of the Department 5.0 PROCEDURE 5.1 For system cleaning 5.1.1 After completion of analysis, clean the HPLC as follows. 5.1.2 Transfer the used glassware for washing & keep aside test tube stands lying near the HPLC system. Clean the surrounding area with tissue paper. 5.1.3 Clean the syringe with repeated rinses of distilled water. 5.1.4 Clean the outer surface of injector by flushing the distilled water with syringe ...

SOP for Calibration of HPLC Column Oven : Pharmaceutical Guidelines SOP for Calibration of HPLC Column Oven Standard operating procedure for the calibration of HPLC Column Oven using calibrated digital thermometer. 1.0 Objective To provide a standard operating procedure for the calibration of HPLC Column Oven. 2.0 Scope This procedure is applicable to all HPLC Column Oven in QC Lab. 3.0 Responsibility 3.1 Doing: Technical Assistant/Executive 3.2 Checking: Executive /Manager 4.0 Accountability Head of the Department 5.0 Procedure Frequency: Once in a year. 5.1 Calibration Procedure for HPLC Column Oven 5.1.1 Keep the sensor probe of reference calibrated digital thermometer inside the HPLC Column Oven keeps its position in about center of the oven chamber. 5.1.2 Set the oven temp. at 25 °C. 5.1.3 Let the oven chamber to achieve set temp. Allow to stabilize it for at least 5 min. 5.1.4 After 5 minutes, observe the temp. in ref. thermometer. 5.1.5 Record the va...

SOP for Calibration of HPLC (Low Pressure Quaternary Gradient Liquid Chromatograph) : Pharmaceutical Guidelines SOP for Calibration of HPLC (Low Pressure Quaternary Gradient Liquid Chromatograph) Standard operating procedure of calibration of HPLC and its components like PUMP, Detector, Column Oven and injector. 1.0 OBJECTIVE To lay down the procedure and frequency for calibration of HPLC. 2.0 SCOPE This procedure is applicable to check the calibration of HPLC Quaternary Gradient system (Model: LC 2010 C, LC 2010 C HT Make: Shimadzu) installed in Quality Control laboratory. 3.0 RESPONSIBILITY 3.1 Doing: Technical Assistant / Executive 3.2 Checking: Executive / Manager 4.0 ACCOUNTABILITY Head of the department 5.0 FREQUENCY: ONCE IN A THREE MONTH. 6.0 PROCEDURE 6.1 Operate the instrument as per respective standard operating procedure. 6.2 For PUMP calibration 6.2.1 Set the flow rate to 1.0 ml/min. 6.2.2 Connect Resisto tubing 2 meter x 0.1 mm ID. in place of...

Solvents used in HPLC Mobile Phase Different types of solvents are used in HPLC mobile phase used for different types of chromatography. These solvents are chosen on the basis of the stationary phase  used for the analysis of the product. Perhaps we have already known HPLC, the high-performance liquid chromatography process that isolates, marks and quantifies the constituents of  a mixture. HPLC is extensively involved in the pharmaceutical and other chemical industries. A pressurized liquid mixture contained in a solvent is  passed under significant high pressure through a solid adsorbent column. Principally the process has two physical phases, solid and liquid. The solvent carrying the mixture is the mobile phase since it moves along the  stationary phase or the absorbent column. We will be discussing the solvents used in the HPLC mobile phase as their selection determine how the  analytes can be separated. The solvents used in the HPLC mobile phase a...