General Test Procedure Loss on drying Purpose This procedure is applicable to all incoming Raw materials, In-process and Finished products. Apparatus Hot air oven/vacuum oven calibrated thermometer Calibrated Balance Reagents None Procedure Weigh a glass stoppered, shallow weighing bottle that has been dried under the same conditions to be … Read more
General Test Procedure Specific Optical Rotation Purpose This procedure is applicable to all incoming materials. Apparatus Polarimeter Polarimeter Tube Calibrated Balance Thermometer Reagents None Procedure The optical rotation, a, unless otherwise specified, is measured at the wavelength of the sodium D-line (589.3 nm) at a temperature of 25° in a layer 1 dm thick. … Read more
General Test Procedure Identification by Solubility Purpose This procedure is applicable to all incoming Raw materials, In-process and Finished products. Apparatus Calibrated Balance. Reagents Solvent as mentioned in STP Procedure Weigh accurately a suitable quantity of sample into a glass stoppered test tube and add specified … Read more
General Test Procedure Identification by UV Purpose This procedure is applicable to all incoming Raw materials, In-process and Finished products. Apparatus UV-Visible spectrophotometer Quartz Cuvettes or Quartz Cells (1.0 cm) Reagents Freshly distilled Water Solvents as specified : AR Grade Chemicals as specified : AR Grade Procedure Set the spectrophotometer in the photometric … Read more
General Test Procedure Identification by TLC Purpose This procedure is applicable to incoming Raw materials, in process and finished products. Apparatus Thin Layer Chromatographic Plates Micro syringes Micropipettes Calibrated disposable capillaries TLC chamber UV chamber Reagents None Procedure Prepare mobile phase by mixing solvents in the ratio as per given in the individual test. Procedure … Read more
General Test Procedure Identification by HPLC Purpose This procedure is applicable to all incoming Raw materials, In-process and Finished products. Apparatus HPLC Column HPLC Vial Reagents HPLC grade Water HPLC grade chemicals Procedure Compare the retention time of standard and sample in the assay test as mentioned in the assay method. The major peak … Read more
General Test Procedure Identification by IR 1.0 Purpose 1.1 This procedure is applicable to all incoming raw materials. 2.0 Apparatus 2.1 Infrared Spectrophotometer 2.2 Hydraulic Pellet Press 2.3 Lab Oven 2.4 Analytical Balance 3.0 Reagents 3.1 Potassium Bromide spectroscopic grade 3.2 Liquid Paraffin AR grade 3.3 Sodium chloride 4.0 Procedure … Read more
Analysis of Glimepiride and Metformin Hydrochloride (SR) Tablets Description : Take 10 tablets, observed visually & record. Identification As per Assay procedure: Positive test for Glimepiride & Metformin Hydrochloride. Average Weight : Weigh accurately 20 tablets, note down the weight and divide the gross weight by 20 to obtain … Read more
SOP FOR CLEANING OF FLUID BED DRYER When a product is changed, or even if the same product granulation is to be continued after ten batches of the product are completed, the cleaning and assembly process that follows will be followed. A Procedure for product to product changeover Cleaning external surface and plenum Clean … Read more
sop for cleaning of dust exhausts OBJECTIVE It is essential that the processing of each and every batch of any product is designed in such a way that there are no chances of cross contamination. Dust extraction “hood assemblies” being the potential contributors towards the problem of cross contamination, need regular cleaning as per … Read more