Tetracycline Appearance: yellow, crystalline powder. 2-[4-(2-Hydroxyethyl)piperazin-1-yl]ethane sulphonicSolubility: very slightly soluble in water, soluble in ethanol
(96 per cent) and in methanol, sparingly soluble in acetone.
Dissolve the above ingredients in about 950 ml of water R,
It dissolves in dilute acid and alkaline solutions.
adjust to pH 7.4 with 1 M sodium hydroxide and add 60 mg IDENTIFICATION
of benzylpenicillin sodium R and a quantity of streptomycinsulphate R equivalent to 100 mg of streptomycin. Dilute to
A. Thin-layer chromatography (2.2.27). Test solution. Dissolve 5 mg of the substance to be
examined in methanol R and dilute to 10 ml with the
Add 2 g/l of glucose R to solution A. Reference solution (a). Dissolve 5 mg of tetracyclinehydrochloride CRS in methanol R and dilute to 10 ml
To solution B add 1 g/l of a preparation of collagenase
obtained from Clostridium histolyticum and of a grade
Reference solution (b). Dissolve 5 mg of tetracycline
suitable for the preparation of dispersed cells. hydrochloride CRS, 5 mg of demeclocyclinehydrochloride R and 5 mg of oxytetracyclinehydrochloride R in methanol R and dilute to 10 ml with
Add 5 g/l of bovine albumin R to solution B. Plate: TLC octadecylsilyl silica gel F
A 9 g/l sterile solution of sodium chloride R containing
Mobile phase: mix 20 volumes of acetonitrile R,
1 g/l of bovine albumin R and adjusted to pH 2.0 with 1 M
20 volumes of methanol R and 60 volumes of a 63 g/l
solution of oxalic acid R previously adjusted to pH 2 with
Store under nitrogen, protected from light, at a temperature
Development: over 3/4 of the plate. Drying: in air. Detection: examine in ultraviolet light at 254 nm. System suitability: the chromatogram obtained with
- the potency in International Units per milligram,
reference solution (b) shows 3 clearly separated spots. Results: the principal spot in the chromatogram obtained
with the test solution is similar in position and size to
the principal spot in the chromatogram obtained with
B. To about 2 mg add 5 ml of sulphuric acid R. A violet-red
colour develops. Add the solution to 2.5 ml of water R. 01/2008:0211 corrected 6.0 C. Dissolve about 10 mg in a mixture of 1 ml of dilute nitric acid R and 5 ml of water R. Shake and add 1 ml of silverTETRACYCLINE nitrate solution R2. Any opalescence in the solution is
not more intense than that in a mixture of 1 ml of dilutenitric acid R, 5 ml of water R and 1 ml of silver nitrate
TESTS pH (2.2.3): 3.5 to 6.0. Suspend 0.1 g in 10 ml of carbon dioxide-free water R. Specific optical rotation (2.2.7): − 260 to − 280 (dried
substance). Dissolve 0.250 g in 0.1 M hydrochloric acid and dilute to
50.0 ml with the same acid. Related substances. Liquid chromatography (2.2.29). Prepare the solutions immediately before use.Test solution. Dissolve 25.0 mg of the substance to be
examined in 0.01 M hydrochloric acid and dilute to 25.0 ml
(4S,4aS,5aS,6S,12aS)-4-(Dimethylamino)-3,6,10,12,12a-
Reference solution (a). Dissolve 25.0 mg of tetracycline
pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-
hydrochloride CRS in 0.01 M hydrochloric acid and dilute
Substance produced by certain strains of StreptomycesReference solution (b). Dissolve 12.5 mg of 4-epitetracyclineaerofaciens or obtained by any other means. hydrochloride CRS in 0.01 M hydrochloric acid and dilute
Content: 88.0 per cent to 102.0 per cent (dried substance). See the information section on general monographs (cover pages)Tetracycline hydrochloride Reference solution (c). Dissolve 10.0 mg of
Heavy metals (2.4.8): maximum 50 ppm. anhydrotetracycline hydrochloride CRS in 0.01 M
0.5 g complies with test C. Prepare the reference solution
hydrochloric acid and dilute to 100.0 ml with the same acid. using 2.5 ml of lead standard solution (10 ppm Pb) R. Reference solution (d). Dissolve 10.0 mg of
Loss on drying (2.2.32): maximum 13.0 per cent, determined 4-epianhydrotetracycline hydrochloride CRS in
on 1.000 g by drying in an oven at 105 °C. 0.01 M hydrochloric acid and dilute to 50.0 ml with the
Sulphated ash (2.4.14): maximum 0.5 per cent, determined Reference solution (e). Mix 1.0 ml of reference solution (a),
2.0 ml of reference solution (b) and 5.0 ml of reference
solution (d) and dilute to 25.0 ml with 0.01 M hydrochloric
Liquid chromatography (2.2.29) as described in the test for
related substances with the following modification. Reference solution (f). Mix 40.0 ml of reference solution (b), Injection: test solution and reference solution (a).
20.0 ml of reference solution (c) and 5.0 ml of reference
Calculate the percentage content of C H N O.
solution (d) and dilute to 200.0 ml with 0.01 M hydrochloricReference solution (g). Dilute 1.0 ml of reference solution (c) Protected from light.
to 50.0 ml with 0.01 M hydrochloric acid. Column:- size: l = 0.25 m, Ø = 4.6 mm;- stationary phase: styrene-divinylbenzene copolymer R
- temperature: 60 °C. Mobile phase: weigh 80.0 g of 2-methyl-2-propanol R
and transfer to a 1000 ml volumetric flask with the aid
A. R1 = NH , R2 = H, R3 = N(CH ) : (4R,4aS,5aS,6S,12aS)-
of 200 ml of water R; add 100 ml of a 35 g/l solution of
4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-
dipotassium hydrogen phosphate R adjusted to pH 9.0
1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-
with dilute phosphoric acid R, 200 ml of a 10 g/l solution
of tetrabutylammonium hydrogen sulphate R adjusted
to pH 9.0 with dilute sodium hydroxide solution R and
B. R1 = CH , R2 = N(CH ) , R3 = H: (4S,4aS,5aS,6S,12aS)-
10 ml of a 40 g/l solution of sodium edetate R adjusted to
2-acetyl-4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-
pH 9.0 with dilute sodium hydroxide solution R; dilute to
6-methyl-4a,5a,6,12a-tetrahydrotetracene-1,11(4H,5H)-
dione (2-acetyl-2-decarbamoyltetracycline),
Flow rate: 1.0 ml/min. Detection: spectrophotometer at 254 nm. Injection: 20 µl; inject the test solution and reference
solutions (e), (f) and (g). System suitability :- resolution: minimum 2.5 between the peaks due to
C. R1 = N(CH ) , R2 = H: (4S,4aS,12aS)-4-(dimethylamino)-
impurity A (1st peak) and tetracycline (2nd peak) and
3,10,11,12a-tetrahydroxy-6-methyl-1,12-dioxo-1,4,
minimum 8.0 between the peaks due to tetracycline and
4a,5,12,12a-hexahydrotetracene-2-carboxamide
impurity D (3rd peak) in the chromatogram obtained
with reference solution (e); if necessary, adjust the
concentration of 2-methyl-2-propanol in the mobile phase; D. R1 = H, R2 = N(CH ) : (4R,4aS,12aS)-4-(dimethylamino)-
- signal-to-noise ratio: minimum 3 for the principal peak in
3,10,11,12a-tetrahydroxy-6-methyl-1,12-dioxo-1,4,
the chromatogram obtained with reference solution (g);
4a,5,12,12a-hexahydrotetracene-2-carboxamide
- symmetry factor: maximum 1.25 for the peak due to
tetracycline in the chromatogram obtained with reference
01/2008:0210 corrected 6.0 Limits:- impurity A: not more than the area of the corresponding
TETRACYCLINE HYDROCHLORIDE
peak in the chromatogram obtained with reference
- impurity B (eluting on the tail of the principal peak):
not more than 0.4 times the area of the peak due to
impurity A in the chromatogram obtained with reference
- impurity C: not more than the area of the corresponding
peak in the chromatogram obtained with reference
- impurity D: not more than the area of the corresponding
peak in the chromatogram obtained with reference
General Notices (1) apply to all monographs and other texts
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s InformationService Contents of the Federal Institute for Vocational ■ HR recruitment in European Education and Training countries November 2008 W. Bertelsmann Verlag ■ Competence-based training ISSN 1615-4355 regulations increase transparency ■ HR recruitment in ■ Occupation with a new European countries c
Tetracycline
Tetracycline hydrochloride