of cefazolin that is designated by the Commissioner as the standard of comparison in determining the potency of the cefazolin working standard.

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

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

(54) [Reserved] (55) Cephradine. The term "cephradine master standard” means a specific lot of cephradine that is designated by the Commissioner as the standard of comparison in determining the potency of the cephradine working standard.

The

(56) Doxorubicin. term "doxorubicin master standard" means a specific lot of crystalline doxorubicin that is designated by the Commissioner as the standard of comparison in determining the potency of the doxorubicin working standard.

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

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

(59) Amikacin. The term "amikacin master standard" means a specific lot of amikacin designated by the Commissioner as the standard of comparison in determining the potency of the amikacin working standard.

(60) Vidarabine. The term “vidarabine master standard" means a specific lot of vidarabine that is designated by the Commissioner as the standard of comparison in determining the potency of the vidarabine working standard.

(61) Ticarcillin. The term "ticarcillin master standard" means a specific lot

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

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

(63) Natamycin. The term "natamycin master standard" means a specific lot of natamycin designated by the Commissioner as the standard of comparison in determining the potency of the natamycin working standard.

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

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

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

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

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

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

the potency of the meclocycline working standard.

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

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

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

The

(74) Piperacillin. term "piperacillin master standard” means a specific lot of piperacillin that is designated by the Commissioner as the standard of comparison in determining the potency of the piperacillin working standard.

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

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

the potency of the ceftizoxime working standard.

term

(80) Cyclosporine. The "cyclosporine master standard” means a specific lot of cyclosporine that is designated by the Commissioner as the standard of comparison in determining the potency of the cyclosporine working standard.

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

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

(83) Clavulanic acid. The term "clavulanic acid master standard" means a specific lot of clavulanic acid or a salt thereof that is designated by the Commissioner as the standard of comparison in determining the potency of the clavulanic acid working standard.

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

term

(86) Ceftazidime. The "ceftazidime master standard" means a specific lot of ceftazidime that is designated by the Commissioner as the standard of comparison in determining the potency of the ceftazidime working standard.

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

(88) Cefotetan. The term "cefotetan master standard” means a specific lot of cefotetan that is designated by the

Commissioner as the standard of comparison in determining the potency of the cefotetan working standard.

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

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

(91) Cefuroxime axetil. The term "cefuroxime axetil master standard" means a specific lot of cefuroxime axetil that is designated by the Commissioner as the standard of comparison in determining the potency of the cefuroxime axetil working standard. (92) Cefmenoxime. The term "cefmenoxime master standard” means a specific lot of cefmenoxime that is designated by the Commissioner as the standard of comparison in determining the potency of the cefmenoxime working standard.

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

(94) Cefotiam. The term "cefotiam master standard” means a specific lot of cefotiam that is designed by the Commissioner as the standard of comparison in determining the potency of the cefotiam working standard.

(95) Clindamycin phosphate. The term "clindamycin phosphate master standard" means a specific lot of clindamycin phosphate that is designed by the Commissioner as the standard for comparison in determining the potency of the clindamycin phosphate standard.

(96) Mupirocin. The term "mupirocin master standard" means a specific lot of mupirocin or a salt thereof that is designated by the Commissioner as the standard of comparison in determining the potency of the mupirocin working standard.

ignated by the Commissioner as the standard of comparison in determining the potency of the cefmetazole working standard.

The

(98) Cefpiramide. term "cefpiramide master standard" means a specific lot of cefpiramide that is designated by the Commissioner as the standard of comparison in determining the potency of the cefpiramide working standard.

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

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

(101) Cefprozil. The term "cefprozil master standard” means a specific lot of the (Z) isomer of cefprozil and a specific lot of the (E) isomer of cefprozil that are designated by the Commissioner as the standard of comparison in determining the potency of the cefprozil working standard.

(102) Idarubicin. The term “idarubicin master standard” means a specific lot of idarubicin that is designated by the Commissioner as the standard of comparison in determining the potency of the idarubicin working standard.

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

(104) Rifabutin. The term “rifabutin master standard" means a specific lot of rifabutin that is designated by the Commissioner as the standard of comparison in determining the potency of the rifabutin working standard.

(105) Cefpodoxime proxetil. The term "cefpodoxime proxetil master standard" means a specific lot of the (R) isomer of cefpodoxime proxetil that is designated by the Commissioner as the standard of comparison in determining the potency of the cefpodoxime proxetil working standard.

(b) Working standards. The potency or purity of each preparation has been determined by comparison with its master standard and each has been designated by the Commissioner as working standards for use in determining the potency or purity of antibiotic substances subject to the regulations in this chapter. Unless otherwise noted, the working standard and the U.S.P. reference standard for the antibiotic drug named are identical.

(1) Penicillin. (i) The term "penicillin G working standard" means a specific lot of a homogeneous preparation of penicillin G.

(ii) [Reserved]

(iii) The term "penicillin V working standard" means a specific lot of a homogeneous preparation of penicillin V. (iv) [Reserved]

(v) The term "methicillin working standard" means a specific lot of a homogeneous preparation of methicillin.

(vi) The term "oxacillin working standard” means a specific lot of a homogeneous preparation of oxacillin.

(vii) The term "ampicillin working standard" means a specific lot of a homogeneous preparation of ampicillin.

(viii) The term "nafcillin working standard" means a specific lot of a homogeneous preparation of nafcillin.

(ix) The term "cloxacillin working standard” means a specific lot of a homogeneous preparation of cloxacillin.

(x) The term "penicillin G procaine working standard” means a specific lot of a homogeneous preparation of penicillin G procaine.

(xi) The term "dicloxacillin working standard" means a specific lot of a homogeneous preparation of dicloxacillin.

term

(46) Minocycline. The "minocycline working standard" means a specific lot of a homogeneous preparation of minocycline.

(47) Spectinomycin. The term “spectinomycin working standard" means a specific lot of a homogeneous preparation of spectinomycin.

(48) Clindamycin palmitate hydrochloride. The term "clindamycin palmitate hydrochloride working standard” means a specific lot of a homogeneous preparation of clindamycin palmitate hydrochloride.

(49) Carbenicillin indanyl. The term "carbenicillin indanyl working standard" means a specific lot of a homogeneous preparation of carbenicillin indanyl.