by - PURPOSE:
To lay down a procedure for determination of loss on drying of softgel.
- SCOPE:
This procedure is applicable for procedure for determination of loss on drying of softgel.
- RESPONSIBILITY:
QC Officer/ QC Executive
- ACCOUNTABILITY:
QC Manager.
- PROCEDURE:
- After received the sample for LOD determination; note down in “INWARD FOR LOD SAMPLE”.
- Cut the capsules by blade and remove the medicament and discard.
- Mop the capsules shell with tissue paper.
- Take the petriplate and weight.
- Weight the capsules shell about 1 – 5 gm. note down the petriplate and capsule shell in record of determination of LOD. Take the about 5 ml of purified water in petriplate.
- Set the 1050C temperature in hot air oven for 1 – 2 hour.
- After drying the capsules shell, Switch OFF the hot air oven and remove the petriplate and cool for room temperature.
- Weight the pertiplate and capsule shell after drying.
- Calculate the weight in loss expressed as:
- Loss on Drying = Loss in Weight X 100 / Weight of Sample
- TRAINING:
Trainer : Manager – Quality Control
Trainees : Staff of the QC departments
- DISTRIBUTION:
Master Copy : QA Department
Controlled Copy : QC Department
Display Copy : QC Department
- ATTACHMENTS:
| Sr. No. | Title | Annexure No. |
| 01. | NA | NA |
- REFERENCES:
In-House
- ABBREVIATIONS:
| Abbreviations | Extended Form |
| SOP | Standard Operating Procedure |
| NA | Not Applicable |
| QC | Quality Control |
| Sr. No. | Serial Number |
| QA | Quality Assurance |
| DEPT. | Department |
- REVISION HISTORY OF CHANGE:
| Sr. No. | Date | Revision Details | Revision No. |
| 01 | 18/01/2020 | NEW SOP | 00 |
