LABEL CLAIM :Each ml contains:
Disodium Edetate (Anhydrous) IP 150mg
BATCH SIZE 100Lts
THEORITICAL YIELD 4878Nos
PRACTICAL YIELD 4780Nos
LABELLED VOLUME 20ml
FILL VOLUME 20.5ml
pH (Limit) 6.5 to 7.5
ASSAY (Limit) 90 - 110%
MANUFACTURING PRECAUTION AND METHOD FOR DISODIUM EDETATE INJECTION
a. At each stage of manufacture follow instruction of Good Manufacturing Practice
b. Check that the area is clear of from previous product materials and documents
c. Get Line Clearance from QA personal
d. Incase of any deviation in ingredient, process and yield, should be investigated and documented, then reported to Production Manager.
1. Weighing material verification:
a. At the time of receipt:
1. Check the Name of the material, Batch No., Mfg. Date, Expy.Date etc., written on the tag of each material.
2. To ensure that the material is dispensed for the batch under manufacture, put a tick mark against the Name of the product, Batch No., Mfg. Date., Expy.Date. etc., on the tag.
b. At the time of use:
1. Take the material required for sifting and mixing and verify the Name of the product, Batch No. Mfg. Date. Exp. Date., etc., written on the tag.
2. Record the weights of all materials on the weighing material sheet.
METHOD OF MANUFACTURING AND PROCESS:
1. Manufacturing Precaution:
1. All the process to be carried out under aseptic condition.
2. Pass nitrogen gas throughout the process.
2. Manufacturing Process:
1. Transfer and dissolve half of the weighed quantity (0.7738kgs) of Sodium Hydroxide to 250Ltrs SS tank in 50Litres of Water for Injection.
2. Transfer and dissolve weighed quantity (17.4353kgs) of Disodium Edetate to the manufacturing tank of step (1) containing dissolved sodium hydroxide.
3. Stir to dissolve completely
4. Adjust the pH to optimum of 7.00 using remaining quantity (0.7738kgs) of sodium hydroxide as 20%w/v and then make up to final volume with Water for Injection i.e., 100 Litres
5. Then send the sample to QC for pH and content analysis (IPQC).
6. Before filtration, validate the membrane by Bubble point test (25PSI)
7. After getting approval from QC filter the solution through sterilized 293mm membrane filter 0.2micron (Nylon)
8. Fill the filtered solution aseptically in sterilized 20cc flint vials with pre and post nitrogen flushing.
9. Then send the filled vials for terminal sterilization at 116°C / 10lbs for 35 mts.
After getting approval from QC, fill the solution in the 20ml flint vials USP Type – I with the specification given