sop for preparation and standardization of 1 M Hydrochloric Acid 1. Preparation: Transfer accurately measured 85ml of hydrochloric acid in a 1000ml volumetric flask. Dilute in sufficient purified water and make up to the mark with purified water. OR As per requirement (consumption history) prepare suitable amount of volumetric solution accordingly. 2. Standardization: … Read more
Preparation and standardization of 0.1 M ceric ammonium sulphate solution 1. Preparation: Weigh accurately about 65g of ceric ammonium sulphate and dissolve, with the aid of gentle heat, in a mixture of 30ml of sulphuric acid and 500ml of purified water. Cool, filter the solution, if turbid, and dilute to 1000ml with the … Read more
sop for preparation and standardization of 0.05 m iodine solution 1. Preparation: Weigh accurately about 14g of iodine and dissolve in a solution of 36g of potassium iodide in 100ml of purified water, add three drops of hydrochloric acid and dilute with purified water to 1000ml. OR As per requirement (consumption history) prepare … Read more
validation protocol for volumetric solution 0.1M ammonium Thiocyanate 1. Approval: This document is prepared by the validation and the GMP compliance team Under the authority of Quality Control Manager. Hence this document before being effective shall be approved by QA team. 2. Purpose: To establish documented evidence, on how the quality of a … Read more
microbiological assay of cyanocobalamin or vitamin B12 1.0 OBJECTIVE To describe the procedure for determine the assay of Cyanocobalamin or vitamin b-12 by biological method using E. Coli mutant MTCC -452. 2.0 PURPOSE It is the policy of (Analytical Division) that a written procedure shall be followed for determine the assay of Cyanocobalamin or … Read more
sop for monitoring of ultraviolet efficiency LAF and pass box 1.0 OBJECTIVE 1.1 To describes a procedure for monitoring of UV light efficiency and burning hour of LAF & Pass box. 2.0 SCOPE 2.1 This procedure applicable for monitoring of UV light efficiency and burning hour of LAF & Pass box. in Microbiology Laboratory … Read more
1.0 OBJECTIVE The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and enables recommended storage conditions, retest periods, and shelf lives to be established. 2.0 … Read more
Media Fill validation Protocol for Liquid Injection (Ampoule) Index Sr. No. Contents Page No. 1. Approvals 2. Overview 3. Responsibility 4. Pre Requisite Checks 5. Filling and Stoppering Operations 6. Methodology Of Validation 7. Precautions 8. Revalidation 9. Frequency 10. Final Report 11. Report Approval 12. Appendix 1.0 Objective The objective of this … Read more
1.0 OBJECTIVE 1.1 To describe a procedure for hold time study of different dosage forms at various stages of processing.. 2.0 SCOPE 2.1 This SOP is applicable for hold time study of tablets, liquids manufactured 3.0 RESPONSIBILITY 3.1 Officer/Executive QA shall be responsible for preparation of a protocol and execution of studies as per approved … Read more
1. The stability of a formulation product should be determined prior to marketing and also prior to adoption of any significant changes in the formulation or manufacturing procedures or packaging materials that may affect the shelf-life of the product 2. Stability study should be carried out a product in each package type in which it … Read more