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Ab

Dhaka, Bangladesh

APPENDIX-C
SUMMARY OF TEST RESULT FOR METRONIDAZOLE 200 MG TABLETS
(Batch Size # 299.862 Kg / 546,000 Tablets)

Finished Product

SAMPLE RESULT
TEST PARAMETERS SPECIFICATION LOCATION/QUANTITY BATCH NO.
(T2940001)
Flat, white or creamy white, scored tablet Flat, creamy white, scored tablet with beveled
1. Appearance/Description 01 Composite
with beveled edges. edges.
2. Moisture Content Not more than 3.3% 01 Composite 1.16 %
A. Infra-red absorption spectrum of extract
is concordant with the reference spectrum
A. Complies
of Metronidazole (RS 229)
3. Identification 01 Composite B. 149.1⁰C
B. Melting point of picrate derivative is
C. Complies
about 150⁰C
C. Color reaction to comply
4. Diameter 12.5 mm ± 0.1 mm 01 Composite 12.52 mm – 12.58 mm

3. Average weight 550 mg (535.0 mg -565.0 mg) 01 Composite 551.2 mg

4. Weight Uniformity ±5% of average weight 01 Composite -2.2% to +2.0%


5. Hardness 70 N-160 N 01 Composite 118 N – 155 N
6. Disintegration Not more than 10 minutes 01 Composite 02 min 54 sec to 04 min 26 sec
7. Friability Not more than 1.0% 01 Composite 0.2%
Not less than 70% of the labeled amount of 98.3% to 101.1%
8. Dissolution 01 Composite
Metronidazole is dissolved in 45 miniutes Avg.: 100.0%
190.0 mg – 210.0 mg of Metronidazole per
9. Assay tablet 01 Composite 198.5 mg (99.2%)
(95.0% - 105.0% of label claim)
10. Microbial Limit Not more than 103 cfu/g 01 Composite TAMC= 20 cfu/g
Summary of Test Result Page 1 of 2 Metronidazole 200 mg Tablets
Ab
Dhaka, Bangladesh

APPENDIX-C
SUMMARY OF TEST RESULT FOR METRONIDAZOLE 200 MG TABLETS
(Batch Size # 299.862 Kg / 546,000 Tablets)

SAMPLE RESULT
TEST PARAMETERS SPECIFICATION LOCATION/QUANTITY BATCH NO.
(T2940001)
Total Aerobic Microbial
Count
Total combined
Not more than 102 cfu/g TYMC= ˂10 cfu/g
Yeast/Moulds Count
Escherichia coli Absent Absent
A. 2-Methyl-5-nitromidazole: Maximum
A. 0.01%
11. Related Substance 0.5% 01 Composite
B. 0.01%
B. Other impurities: Maximum 0.5%
Conclusion: All parameter complies with all the set specifications.

Prepared by : Checked by : Approved by:

Jarin Rahman Moromi Md. Enamul Haque Mahmudul Hasan


Executive, QA Sr. Executive, QA Deputy Manager, QA

Summary of Test Result Page 2 of 2 Metronidazole 200 mg Tablets

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