SOP for Hold Time Studies Protocol of Ornidazole Tablets 500 mg
Process Step – Blending/ Lubrication
About 500 gms material from blended mass is kept under simulating conditions. The material is subjected to analysis for Assay of Ornidazole,Total & single impurity and LOD at 0 day, after 7th day & after 15th day. These samples are tested for Bulk Density, Tapped Density, Compressibility Index and Hausner Ratio to rule out the de-blending of the materials. Hold time Study shall be carried out in one batch only.
Samples are also subjected separately for microbiological testing at 0 day, 7th day and 15th day.
Storage Environment (Bulk Storage Area)
Temperature : NMT 25ºC
Relative Humidity: NMT 45%
Closed S.S. Container / IPC lined with double polyethylene bags of appropriate size.
SILVER SULPHADIAZINE AND CHLORHEXIDINE CREAM
Test Method
Description, Assay of Ornidazole, LOD: Refer STP No. ____________
Related substances: Refer STP No. ____________
Microbiological Limits:
Refer GTP No.: ________________ for microbiological testing as per Ph.Eur.
Acceptance Criteria
Description: Cream to light yellow coloured, flowing granules. sampled after 7th day and 15th day are comparable with that of 0 hr (initial).
Assay: Each 700 mg of granules contains not less than 95.0% and not more than 105.0% (475.0 mg to 525.0 mg) of the label claim of Ornidazole C7H10CIN3O3.
Related substances:
Single largest impurity : Not more than 0.5%
Total impurities : Not more than 1.0%
Loss on drying: Between 1.0% to 3.0% w/w, determined at 600C for 10 minutes.
Microbial Limits:
Total aerobic microbial count: NMT 500 cfu/g.
Total combined molds and yeasts count: NMT 50 cfu/g.
Escherichia coli: should be absent
Salmonella species: should be absent
Pseudomonas aeruginosa: should be absent
Staphylococcus aureus: should be absent
Process Step – Tablet Compression
After completion of compression about 200.0 gms of compressed tablets are kept under simulating conditions for carrying holding studies. The sampling is done at 0 day, after 7th day & after 15th day. The sample is evaluated for the tests like Description, Assay and Related substances. Holding Study shall be carried out in one batch only.
Samples shall be subjected separately for microbiological testing at 0 day, after 7th day & after 15th day.
Storage Environment(Bulk storage Area)
Temperature : NMT 25ºC
Relative Humidity: NMT 45%
Closed HDPE lined with double polyethylene bags container of appropriate size.
Test Method
Description, Assay, Related substances : Refer STP No. _____________
Uniformity of dosage units : Refer STP No._____________
Disintegration time : Refer STP No. ________________
Dissolution time : Refer STP No. ________________
Microbial Limits:
Refer GTP No.: ____________ for microbiological testing as per Ph.Eur.
Acceptance Criteria (0 day, 7th day, and 15th day)
Description: Cream to light yellow coloured, Oblong, Biconvex, uncoated tablets scored on one side and plain on other.
Assay: Each uncoated tablet contains not less than 95.0% and not more than 105.0% (475.0 mg to 525.0 mg) of the label claim of Ornidazole C7H10CIN3O3.
Uniformity of dosage units : (By Mass variation )
The acceptance value of the 10 dosage units is less than or equal to L1 (L1=15)
Disintegration time : Not more than 15 minutes
Dissolution time: Not less than 80% of the labeled amount of C7H10CIN3O3 is dissolved in 45 mins.
Related substances:
Single largest impurity : Not more than 0.5%
Total impurities : Not more than 1.0%
Microbial Limits:
Total aerobic microbial count: NMT 500 cfu/g.
Total combined molds and yeasts count: NMT 50 cfu/g.
Escherichia coli: should be absent
Salmonella Species: should be absent
Pseudomonas aeruginosa: should be absent
Staphylococcus aureus: should be absent
