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Test Results1
Test Results1
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
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.