Lapas attēli
PDF
ePub

(44) Vidarabine. Vidarabine is a purine glycoside antibiotic substance produced by the growth of Streptomyces antibioticus, and each of the same substances produced by any other means is a kind of vidarabine.

(45) Natamycin. Each of the antibiotic substances produced by the growth of Streptomyces natalensis, and each of the same substances produced by any other means, is a kind of natamycin.

(46) Daunorubicin. Each of the antibiotic substances produced by the growth of Streptomyces coeruleorubidus and each of the same substances produced by any other means is a kind of daunorubicin.

(47) Sisomicin. A specific one of the antibiotic substances produced by the growth of Micromonospora inyoensis, and the same substance produced by any other means, is a kind of sisomicin. (48)

5-oxa-1

Moxalactam. azabicyclo[4.2.0]oct-2-ene-2-carboxylic

[blocks in formation]

hydroxyphenyl)acetyl]-amino]-7methoxy-3-[[(1-methyl-1H-tetrazol-5

yl)thio]-methyl]-8-oxo-, disodium salt.

(49) Cefoperazone. Cefoperazone is a semi-synthetic antibiotic substance produced by the acylation of the amino group at the 7 position of 7aminocephalosporanic acid with α-(4ethyl-2,3-dioxo-1

piperazinecarboxamido)-a-(4

hydroxyphenyl) acetic acid and introduction of a methylthiotetrazol group at the 3 position.

(50) Netilmicin. Netilmicin is a semisynthetic antibiotic of the aminoglycoside group derived from sisomicin, and each of the same substances produced by any other means is a kind of netilmicin. It is D-Streptamine, 4-O-[3-amino-6-(aminomethyl)

3,4-dihydro-2H-pyran-2-yl]-2-deoxy-6-O[3-deoxy-4-C-methyl-3-(methylamino)B-L-arabinopyranosyl]-No1-ethyl-,

cis)-.

(2S

[blocks in formation]

5yl]-thio]methyl]-, disodium salt, [6R[6α7ẞ(R*)]].

(53) Clavulanic acid. Clavulanic acid is an antibiotic substance produced by the growth of Streptomyces clavuligerus having the structure described as follows: Z-(2R, 5R)-3-(2hydroxyethylidene)-7-oxo-4-oxa-1azabicyclo[3.2.0]heptane-2-carboxylic acid, and each of the same substances produced by any other means, is a kind of clavulanic acid.

(54) Ceftriaxone. Ceftriaxone is a semi-synthetic antibiotic substance produced by the addition of S-2benzothiazolyl-2-(2-aminothiazol-4-yl)

2-methoxyiminothioacetate to the 7 amino group of 7-amino-3-(2,5-dihydro-2 methyl-5,6-dioxo-1,2,4-triazin-3-yl)thiomethyl-3-cephem-4-carboxylic acid. (55) Imipenem monohydrate. Imipenem monohydrate is an antibiotic substance having the chemical structure described by the following name: [5R[5α,6a,(R*)]]-6-(1-hydroxyethyl)-3-[[2[(iminomethyl)amino]ethyl]thio]-7oxo-1-azabicyclo[3.2.0]-hept-2-ene-2-carboxylic acid monohydrate.

(56) Aztreonam. [2S[2alpha,3beta(Z)]]-2

[[[1-(2-amino-4-thiazolyl)-2-[(2-methyl4-oxo-1-sulfo-3-azetidinyl)amino]-2oxoethylidene]amino]oxy]-2

methylpropanoic acid.

(57) Sulbactam. Sulbactam is a semisynthetic antibiotic substance produced by the oxidation of the sulfur atom at the 4 position to its dioxide and the deamination at the 6 position of (2S,5R)-6-amino-3,3-dimethyl-7-oxo-4 thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid (6-APA).

(58) Cefmenoxime. Cefmenoxime is 5

thia-1-azabicyclo[4.2.0]oct-2-ene-2-car

boxylic acid, 7-[[(2-amino-4-thiazolyl)

(methoxyimino)acetyl]amino]-3-[[(1methyl-1H-tetrazol-5-yl)thio]methyl]-8

oxo-, [6R-[6-a,7-ẞ(Z)]]-.

(59) Cefixime. Cefixime is a semisynthetic antibiotic substance produced by the acylation of the amino group at the 7 position of 7aminocephalosporanic acid with a ẞ-[(2amino-4-thiazolyl)

(carboxymethoxy)imino] acetyl group and the introduction of a vinyl group at the 3 position.

(60) Cefotiam. Cefotiam is an antibiotic substance having the chemical structure described by the following

[blocks in formation]

(63) Cefpiramide. Cefpiramide is an antibiotic substance having the chemical structure described by the following name: (6R, 7R)-7-[(R)-2-(4-hydroxy-6methyl-nicotinamido)-2-(phydroxyphenyl)acetamido]-3-[[(1methyl-1H-tetrazol-5-yl)thio]methyl]-8oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene2-carboxylic acid.

(64) Clarithromycin. Clarithromycin is 6-O-methylerythromycin A.

(65) Azithromycin. Azithromycin is an antibiotic substance having the chemical structure described by the following name:

(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13[(2,6-dideoxy-3-C-methyl-3-O-methyl-aL-ribo-hexopyranosyl)oxy]-2-ethyl3,4,10-trihydroxy-3,5,6,8,10,12,14heptamethyl-11-[[3,4,6-trideoxy-3

(dimethylamino)-ß-D-xylohexopyranosyl)oxy]-1-oxa-6azacyclopentadecan-15-one.

(66) Cefprozil. Cefprozil is an antibiotic substance having the chemical structure described by the following (6R,7R)-7-[(R)-2-amino-2-(p

name:

hydroxyphenyl)acetamido]8-oxo-3-propenyl-5-thia-1-azabicyclo[4.2.0]oct-2ene-2-carboxylic acid. It is a mixture of the Z (cis) and E (trans) isomers in an approximate ratio of 9:1, respectively.

(67) Idarubicin. Idarubicin is an anthracycline antibiotic substance having the chemical structure described by the following name: 5,12Naphthacenedione, 9-acetyl-7-[(3

amino-2,3,6-trideoxy-a-L-lyxo

hexopyranosyl)oxy]-7,8,9,10-tetrahydro

6,9,11-trihydroxy-(7S-cis).

[blocks in formation]

(70) Cefpodoxime proxetil. Cefpodoxime proxetil is an antibiotic substance having the chemical structure described by the following name: (±)-1-Hydroxyethyl(+)-(6R,7R)-7-[2-(2-amino-4thiazolyl)glyoxylamido]-3

(methoxymethyl)-8-oxo-5-thia-1

azabicyclo[4.2.0]oct-2-ene-2

carboxylate,72-(Z)-(O-methyloxime),

isopropyl carbonate (ester). (b) [Reserved]

[39 FR 18925, May 30, 1974]

EDITORIAL NOTE: For FEDERAL REGISTER Citations affecting § 430.4, see the List of CFR Sections Affected in the Finding Aids section of this volume.

[blocks in formation]

as the standard of comparison in determining the potency of the methicillin working standard.

(vii) Oxacillin. The term "oxacillin master standard" means a specific lot of crystalline oxacillin that is designated by the Commissioner as the standard of comparison in determining the potency of the oxacillin working standard.

(viii) Ampicillin. The term "ampicillin master standard" means a specific lot of crystalline ampicillin that is designated by the Commissioner as the standard of comparison in determining the potency of the ampicillin working standard.

(ix) Nafcillin. The term "nafcillin master standard” means a specific lot of crystalline nafcillin that is designated by the Commissioner as the standard of comparison in determining the potency of the nafcillin working standard.

designated by the Commissioner as the standard of comparison in determining the potency of the chlortetracycline working standard.

(5) Demeclocycline. The

term

"demeclocycline master standard" means a specific lot of crystalline demeclocycline hydrochloride that is designated by the Commissioner as the standard of comparison in determining the potency of the demeclocycline working standard.

(6) Tetracycline. The term "tetracycline master standard" means a specific lot of crystalline tetracycline hydrochloride that is designated by the Commissioner as the standard of comparison in determining the potency of the tetracycline working standard.

(7) Rolitetracycline. The term "rolitetracycline master standard" means a specific lot of crystalline rolitetracycline that is designated by the Commissioner as the standard of comparison in determining the potency of the rolitetracycline working standard.

(x) Cloxacillin. The term "cloxacillin master standard" means a specific lot of crystalline cloxacillin that is designated as the standard of comparison in determining the potency of the (8) Chloramphenicol. The term “chlorcloxacillin working standard. amphenicol master standard" means a Dicloxacillin. lot (xi) of The specific term crystalline chlor"dicloxacillin master standard" means amphenicol that is designated by the Commissioner as the standard of coma specific lot of dicloxacillin that is designated by the Commissioner as the parison in determining the potency of standard of comparison in determining the chloramphenicol working standard. the potency of the dicloxacillin working standard.

(xii) The term "hetacillin working standard" means a specific lot of homogenous preparation of hetacillin.

(2) Streptomycin. The term "streptomycin master standard" means a specific lot of streptomycin that is designated by the Commissioner as the standard of comparison in determining the potency of the streptomycin working standard.

(3) Dihydrostreptomycin. The term "dihydrostreptomycin master standard" means a specific lot of crystalline dihydrostreptomycin that is designated by the Commissioner as the standard of comparison in determining the potency of the dihydrostreptomycin working standard.

(4) Chlortetracycline. The term "chlortetracyclin master standard" means a specific lot of crystalline chlortetracycline hydrochloride that is

(9) Bacitracin The term "bacitracin master standard" means a specific lot of bacitracin that is designated by the Commissioner as the standard of comparison in determining the potency of the bacitracin working standard. (10) [Reserved]

[blocks in formation]

determining the potency of the colistin working standard.

(13) Colistimethate. The term "colistimethate master standard" means a specific lot of colistimethate designated by the Commissioner as the standard of comparison in determining the potency of the colistimethate working standard.

(14) Cycloserine. The term "cycloserine master standard" means a specific lot of cycloserine designated by the Commissioner as the standard of comparison in determining the potency of the cycloserine working standard.

(15) Erythromycin. The term “erythromycin master standard" means a specific lot of erythromycin designated by the Commissioner as the standard of comparison in determining the potency of the erythromycin working standard.

(16) Gramicidin. The term “gramicidin master standard" means a specific lot of gramicidin designated by the Commissioner as the standard of comparison in determining the potency of the gramicidin working standard.

(17) Griseofulvin. The term "griseofulvin master standard" means a specific lot of griseofulvin designated by the Commissioner as the standard of comparison in determining the potency of the griseofulvin working standard. (18) Kanamycin. The term "kanamycin master standard" means a specific lot of kanamycin designated by the Commissioner as the standard of comparison in determining the potency of the kanamycin working standard.

(19) Neomycin. The term "neomycin master standard" means a specific lot of neomycin designated by the Commissioner as the standard of comparison in determining the potency of the neomycin working standard.

(20) Novobiocin. The term "novobiocin master standard” means a specific lot of novobiocin designated by the Commissioner as the standard of comparison in determining the potency of the novobiocin working standard.

(21) Nystatin. The term "nystatin master standard” means a specific lot nystatin designated by the Commissioner as the standard of comparison in determining the potency of the nystatin working standard.

(22) Oleandomycin. The term "oleandomycin master standard"

[blocks in formation]

(27) Vancomycin. The "vancomycin master standard” means a specific lot of vancomycin designated by the Commissioner as the standard of comparison in determining the potency of the vancomycin working standard. (28) [Reserved]

(29) Troleandomycin. The term "troleandomycin master standard" means a specific lot of troleandomycin designated by the Commissioner as the standard of comparison in determiing the potency of the troleandomycin working standard.

The

term

(30) Gentamicin. "gentamicin master standard” means a specific lot of gentamicin designated by the Commissioner as the standard of comparison in determining the potency of the gentamicin working standard.

(31) Dactinomycin. The term "dactinomycin master standard" means a specific lot of dactinomycin designated by the Commissioner as the standard of comparison in determining the potency of the dactinomycin working standard.

(32) Candicidin. The term "candicidin master standard” means a specific lot of candicidin that is designated by the Commissioner as the standard of comparison in determining the potency of the candicidin working standard.

(33) Cephalothin. The term "cephalothin master standard" means a specific lot of cephalothin designated by the Commissioner as the standard of comparison in determining the potency of the cephalothin working standard.

(34) Lincomycin. The term "lincomycin master standard" means a specific lot of lincomycin designated by the Commissioner as the standard of comparison in determining the potency of the lincomycin working standard. (35) Methacycline. The term "methacycline master standard" means a specific lot of methacycline designated by the Commissioner as the standard of comparison in determining the potency of the methacycline working standard.

a

lot

(36) Doxycycline. The term "doxycycline master standard” means specific of α-6deoxyoxytetracycline designated by the Commissioner as the standard of comparison in determining the potency of the doxycycline working standard.

(37) Cephaloridine. The term "cephaloridine master standard" means a specific lot of cephaloridine that is designated by the Commissioner as the standard of comparison in determining the potency of the cephaloridine working standard. (38) Plicamycin. The term “plicamycin master standard” means a specific lot of plicamycin designated by the Commissioner as the standard of comparison in determining the potency of the plicamycin working standard. (39) Clindamycin. The term "clindamycin master standard” means a specific lot of clindamycin designated by the Commissioner as the standard of comparison in determining the potency of the clindamycin working standard.

(40) Cephaloglycin. The term "cephaloglycin master standard" means a specific lot of cephaloglycin designated by the Commissioner as the standard of comparison in determining the potency of the cephaloglycin working standard.

The

(41) Carbenicillin. term "carbenicillin master standard" means a specific lot of carbenicillin designated by the Commissioner as the standard of comparison in determining the potency of the carbenicillin working standard.

[blocks in formation]

term

(46) Minocycline. The "minocycline master standard" means a specific lot of minocycline designated by the Commissioner as the standard of comparison in determining the potency of the minocycline working standard.

(47) Spectinomycin. The term “spectinomycin master standard" means a specific lot of spectinomycin. designated by the Commissioner as the standard of comparison in determining the potency of the spectinomycin working standard.

(48) Clindamycin palmitate hydrochloride. The term "clindamycin palmitate hydrochloride master standard" means a specific lot of clindamycin palmitate hydrochloride designated by the Commissioner as the standard of comparison in determining the potency of the clindamycin palmitate hydrochloride working

[blocks in formation]
« iepriekšējāTurpināt »