Form
Powder
Appearance
Yellowcrystallinepowder
Source
Streptomycessp.
ImpurityProfile
4-Epitetracycline:Notmorethan3.0%
Anhydrotetracycline:Notmorethan0.5%
4-Epianhydrotetracycline:Notmorethan0.5%
2-Acetyl-2-decarbamoyl-tetracycline:Notmorethan1.5%
HeavyMetals:≤50ppm
SulphateAsh:≤0.5%
BacterialEndotoxin:≤0.5IU/mg
Potency(onadrybasis)
≥900µg/mg
pH
1.8-2.8
OpticalRotation
-240°to-255°
Assay
(OnDriedBasis):95.0-102.0%
LossonDrying
≤2.0%
ResidualSolvents
1-Butanol:Notmorethan5000ppm
Acetone:Notmorethan5000ppm