- Product Details
Keywords
- API
Quick Details
- ProName: Doxycycline HCl
- CasNo: 10592-13-9
- ProductionCapacity: Metric Ton/Day
- Purity: 95.0%~102.0%
- LimitNum: 0 Metric Ton
Superiority
GMP certificate
Details
Item | Standard | Result | |||||
Character | Yellow crystalline Powder | Complies | |||||
Solubility | Freely soluble in water and in methanol, sparingly soluble in ethanol ( 96 per cent ). It dissolves in solutions of alkali hydroxides and carbonates. | Complies | |||||
Identification | a) HPLC | Complies | |||||
b) Sulphurie acid reaction a yellow colour develops | Complies | ||||||
c) It gives reaction of chlorides | Complies | ||||||
PH | 2.0-3.0 | 2.5 | |||||
Specific Absorbance |
At 349 nm E ( 1% ) 300-335 ( anhydrous and ethanol-free substance ) |
323 | |||||
Specific Optical Rotation |
-120°~-105° ( anhydrous and ethanol-free substance ) |
-111° | |||||
Heavy Metal | ≤50ppm | <50ppm | |||||
Light-absorbing Impurities |
At 490nm≤0.07 ( anhydrous and ethanol-free substance ) |
0.02 | |||||
a) 6-epidoxycycline ≤2.0% | 1.9% | ||||||
b) metacycline ≤2.0% | 0.3% | ||||||
c) 4-epidoxycycline ≤ 0.5% | not found | ||||||
d) 4-epi-6-epidoxycycline≤ 0.5% | not found | ||||||
e) oxytetracycline≤ 0.5% | not found | ||||||
f) 2-acety-2-decarbamoyldoxycycline ADOT ≤ 0.5% | 0.4% | ||||||
g) any other impurity≤ 0.5% | not found | ||||||
Ethanol | 4.3-6.0% ( m/m ) | 4.7% | |||||
Sulphated Ash | ≤ 0.4% | 0.05% | |||||
Water | 1.4-2.8% | 1.9% | |||||
Assay |
95.0%-102.0% ( C22H25CIN2O8 ) ( anhydrous and ethanol-free substance ) |
96.90% | |||||
Conclusion: This product fulfills EP7.4, BP2010. |