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Hold Time Studies Protocol of Ornidazole Tablets 500 mg

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.

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

Hold-Time Studies Guideline

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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