PRODUCT NAME: CIMITIDINE USP 32 (TYPE A)

EXPIRY DATE:5 years

CAS NO.:

ITEM         

STANDARD

RESULT

APPEARANCE

WHITE OR OF-WHITE CRYSTALLINE POWDER ODORLESS,BITTER TASTE

COMPLIES

IDENTIFICATION

IR ABSORPTION

ConSIST WITH THE SPECTRA OBTAINED WITH CIMETIDINE CRS.

COMPLIES

UV ABSORPTION

SHOULD CONFORM

COMPLIES

MELTING POINT

139.0-144.0°C

141.2-142.0°C

LOSS ON DRYING

≤0.5%

0.09%

RESIDUE ON IGNITION

≤0.2 %

0.11%

ASSAY

98.0-102.0 %

99.92%

CHROMATOGRAPHIC PURITY

SINGLE PEAK RESPONSE

≤0.2 %

0.13%

THE SUM OF ALL PEAK RESPONSES

≤1.0%

0.57%

ORGANIC VOLATILE IMPURITIES

≤0.5%

COMPLIES

HEAVY metaLS

≤20PPM

COMPLIES

CONCLUSION

COMPLIED TO THE STANDARD OF USP32