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PRODUCT NAME: DOXYCYCLINE HYCLATE EXPIRY DATE:4 years
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|
TEST |
STANDARDS |
RESULTS |
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|
CHARACTERISTICS |
A YELLOW CRYSTALLINE POWDER HYGROSCOPIC |
CONFORMS |
|
|
IDENTIFICATION |
TLC |
POSITIVE |
|
|
SULPHURIC ACID YELLOW COLOR REACTION |
POSITIVE |
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|
CHLORIDE’S REACTION |
POSITIVE |
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|
ACIDITY |
PH2.0~3.0 |
2.38 |
|
|
ABSORBANCE |
300~330 |
301 |
|
|
SPECIFIC OPTICAL ROTATION |
-105°~ -120° |
-107.5° |
|
|
HEAVY METALS |
NOT MORE THAN 50ppm |
<20ppm |
|
|
LIGHT-ABSORBING IMPURITIES |
NOT MORE THAN 0.07 |
0.011 |
|
|
RELATED SUBSTANCES |
METHACYCLINE |
NOT MORE THAN 2.0% |
0.32% |
|
6EPIDOXYCYCLINE |
NOT MORE THAN 2.0% |
0.42% |
|
|
OTHER IMPURITIES |
NOT MORE THAN 0.5% |
0.42% |
|
|
ETHANOL |
4.3%~6.0% |
4.99% |
|
|
SULPHATED ASH |
NOT MORE THAN 0.4% |
0.12% |
|
|
WATER |
1.4%~2.8% |
1.98% |
|
|
ASSAY (ANHYDROUS AND ETHANOL FREE) |
95.0%~102.0% |
98.18% |
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|
CONCLUSION: THE PRODUCT FULFILS BP2002 SPECIFICATION |
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