product Name | TetracyclineHydrochloride |
Synonyms | [4S-(4alpha,4aalpha,5aalpha,6beta,12aalpha)]-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamidehydrochloride; Tetracycline hcl; (2Z,4S,4aS,5aS,6S,12aS)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-6,10,11,12a-tetrahydroxy-6-methyl-4a,5a,6,12a-tetrahydrotetracene-1,3,12(2H,4H,5H)-trionehydrochloride; (2E,6S,12aS)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-6,10,11,12a-tetrahydroxy-6-methyl-4a,5a,6,12a-tetrahydrotetracene-1,3,12(2H,4H,5H)-trione hydrochloride;4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide hydrochloride (1:1) |
Molecular Formula | C22H25ClN2O8 |
Molecular Weight | 480.8955 |
InChI | InChI=1/C22H24N2O8.ClH/c1-21(31)8-5-4-6-11(25)12(8)16(26)13-9(21)7-10-15(24(2)3)17(27)14(20(23)30)19(29)22(10,32)18(13)28;/h4-6,9-10,15,25,27-28,31-32H,7H2,1-3H3,(H2,23,30);1H |
CAS Registry Number | 64-75-5;1170-81-6 |
EINECS | 200-593-8 |
Molecular Structure |
|
Melting point | 223℃ |
Boiling point | 799.4°C at 760 mmHg |
Flash point | 437.3°C |
Water solubility | 50 g/L |
Vapour Pressur | 5.82E-27mmHg at 25°C |
Hazard Symbols | Xi:Irritant; |
Risk Codes | R36/37/38:; |
S26:; |
USP32
ITEM | STANDARD | RESULTS |
Appearance | Yellow crystalline powder | Conforms |
Identification | A: IR | Conforms |
B: Ultraviolet Absorption | Conforms | |
C: | Conforms | |
D: | Conforms | |
E: | Conforms | |
F: | Conforms | |
Specific Rotation | -240°- -255° | -245° |
Crystallinity | Meets the requirements | Conforms |
Heavy metals | 0.005% | 0.0023% |
pH | 1.8 ~ 2.8 | 2.1 |
Loss on drying | Not more than 2.0% | 1.1% |
Limit of 4-epianhydrotetracycline | Not more than 2.0% | 0.8% |
Assay | Tetracycline Hydrochloride has apotency of not less than 900μg ofC22H24ClN2O8 HCl per mg. | 99μg |
BP2009
ITEM | STANDARD | RESULTS |
Appearance | Yellow, crystalline powder | Yellow crystalline powder |
Solubility | Soluble in water, slightly soluble in ethanol(96 per cent), practically insoluble in acetone. It dissolves in solutions ofalkali hydroxides and carbonates. Solutions in water become turbid on standing, owing to the precipitation of tetracycline. | Conforms |
Identification | A. Thin-layer chromatography |
|
B. Correspond with the standards | Conforms | |
C. Gives reaction of chlorides | Conforms | |
Specific Optical Rotation | -240°~ -255°(dried substance) | -246° |
pH | 1.8 ~ 2.8 | 2.1 |
Related substance | Impurity A: Not more than 3.0% | 1.7% |
Impurity B: Not more than 1.5% | 1.0% | |
Impurity C: Not more than 0.5% | 0.23% | |
Impurity D: Not more than 0.5% | 0.31% | |
Heavy metals | Maximum 50ppm | 20ppm |
Loss on drying | Maximum 2.0% | 1.2 |
Sulphated ash | Maximum 0.5% | 0.15 |
Bacterial endotoxins | Less than 0.5IU/mg | 0.32IU/mg |
Assay | 95.0%~ 102.0% | 99% |
Storage: Preserve in tight, light-resistant containers.
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