(60) Vidarabine. The term "vidarabine working standard" means a specific lot of a homogeneous preparation of vidarabine. (61) Ticarcillin. The term "ticarcillin working standard" means a specific lot of a homogeneous preparation of ticarcillin. (62) Cefadroxil. The term "cefadroxil working standard” means a specific lot of a homogeneous preparation of cefadroxil. (63) Natamycin. The term “natamycin working standard" means a specific lot of a homogeneous preparation of natamycin. (64) Cefoxitin. The term "cefoxitin working standard" means a specific lot of a homogeneous preparation of cefoxitin. (76) Cefoperazone. The "cefoperazone working standard" means a specific lot of a homogeneous preparation of cefoperazone. (77) Netilmicin. The term "netimicin working standard" means a specific lot of a homogeneous preparation of netilmicin. term (78) Cefuroxime. The "cefuroxime working standard" means a specific lot of a homogeneous preparation of cefuroxime. (79) Ceftizore. The term "ceftizoxime working standard" means a specific lot of a homogeneous preparation of ceftizoxime. term (88) Ceftazidime. The "ceftazidime working standard" means a specific lot of a homogeneous preparation of ceftazidime. (89) Imipenem. The term "imipenem working standard” means a specific lot of a homogeneous preparation of imipenem. (90) Cefotetan. The term "cefotetan working standard” means a specific lot of a homogeneous preparation of cefotetan. (91) Aztreonam. The term "aztreonam working standard” means a specific lot of a homogeneous preparation of aztreonam. (92) Sulbactam. The term "sulbactam working standard” means a specific lot of a homogeneous preparation of sulbactam. (105) Loracarbef. The term "loracarbef working standard” means a specific lot of a homogeneous preparation of loracarbef. (106) Rifabutin. The term “rifabutin working standard” means a specific lot of a homogeneous preparation of rifabutin. (107) Cefpodoxime proxetil. The term "cefpodoxime proxetil working standard” means a specific lot of a homogeneous preparation of cefpodoxime proxetil. [39 FR 18925, May 30, 1974] EDITORIAL NOTE: For FEDERAL REGISTER citations affecting §430.5, see the List of CFR Sections Affected appearing in the Finding Aids section of this volume. § 430.6 Definitions of the terms "unit" and “microgram” as applied to antibiotic substances. Unless it has been otherwise specified in the individual definitions in this section, the activity assigned to each "unit" or "microgram" is equivalent to an International Unit, if such has been defined by the World Health Organization. (a) "Unit"-(1) Penicillin-(i) Penicillin G. The term "unit" applies to penicillin G means the penicillin activity (potency) contained in 0.600 microgram of the penicillin G master standard. (ii) [Reserved] (iii) Penicillin V. The term "unit" applied to penicillin V means the penicillin activity (potency) contained in 0.590 microgram of the penicillin V master standard. (2) Bacitracin. The term "unit" applied to bacitracin means a bacitracin activity (potency) contained in 13.51 micrograms of the bacitracin master standard, except that when the activity (potency) of bacitracin is expressed in terms of its weight, as in the feed and drinking water of animals, 1 gram of activity is equivalent to 42,000 units. (3) Nystatin. The term "unit" applied to nystatin means the nystatin activity (potency) contained in 0.2817 microgram of the nystatin master standard when dried for 2 hours at 40° C. and a pressure of 5 millimeters or less. (4) Polymyxin B. The term "unit" applied to polymyxin B means the polymyxin activity (potency) contained in 0.1274 microgram of the polymyxin B master standard when dried for 3 hours at 60° C. and a pressure of 5 millimeters or less. (5) Bleomycin. The term "unit" applied to bleomycin means the bleomycin activity (potency) contained in 0.637 milligram of the bleomycin master standard. (b) “Microgram”—(1) Streptomycin. The term "microgram" applied to streptomycin means the streptomycin activity (potency) contained in 1.250 micrograms of the streptomycin master standard after it is dried for 3 hours at 60° C. and a pressure of 5 millimeters or less. (2) Dihydrostreptomycin. "microgram" The term applied to dihydrostreptomycin means the dihydrostreptomycin activity (potency) contained in 1.25 micrograms of the dihydrostreptomycin master standard after it is dried for 4 hours at 100° C. and a pressure of 50 microns or less. (3) Chlortetracycline. The term "microgram" applied to chlortetracycline means the chlortetracycline activity (potency) contained in 1.0 microgram of the chlortetracycline master standard. means term to the (6) Rolitetracycline. The term "microgram” applied rolitetracycline rolitetracycline activity (potency) contained in 1.0 microgram of the rolitetracycline master standard when dried for 3 hours at 60° C. and a pressure of 5 millimeters or less. (7) Chloramphenicol. The term “microgram” applied to chloramphenicol means the chloramphenicol activity (potency) contained in 1.0 microgram of the chloramphenicol master standard. (8) Methicillin. The "microgram" applied to methicillin means the methicillin activity (potency) contained in 1.105 micrograms of the methicillin master standard. term (9) Oxacillin. The term "microgram” applied to oxacillin means the oxacillin activity (potency) contained in 1.111 micrograms of the oxacillin master standard. (10) [Reserved] (11) Amphotericin A. The term "microgram" applied to amphotericin A means the amphotericin A activity (potency) contained in 1.0 microgram of the amphotericin A master standard when dried for 3 hours at 60° C. and a pressure of 5 millimeters or less. term (12) Amphotericin B. The "microgram" applied to amphotericin B means the amphotericin B activity (potency) contained in 1.014 micrograms of the amphotericin B master standard when dried for 3 hours at 60° C. and a pressure of 5 millimeters or less. (13) Colistin. The term "microgram” applied to colistin means the colistin base activity (potency) contained in 1.495 micrograms of the colistin master standard when dried for 3 hours at 60° C. and a pressure of 5 millimeters or less. The numerical value of a microgram of colistin is not equivalent to the International Unit. (14) Colistimethate. The term "microgram" applied to colistimethate the activity (potency) calmeans culated as colistin base that is contained in 1.938 micrograms of the colistimethate master standard when dried for 3 hours at 60° C. and a pressure of 5 millimeters or less. The numerical value of a microgram of colistimethate is not equivalent to the International Unit. (15) Cycloserine. The term "microgram" applied to cycloserine means the cycloserine activity (potency) contained in 1.0 microgram of the cycloserine master standard when dried for 3 hours at 60° C. and a pressure of 5 millimeters or less. (18) Griseofulvin. The term "microgram" applied to griseofulvin means the griseofulvin activity (potency) contained in 1.0 microgram of the griseofulvin master standard. (19) Kanamycin. The term "microgram" applied to kanamycin means the kanamycin base activity (potency) contained in 1.299 micrograms of the kanamycin master standard. (20) Neomycin. The term "microgram” applied to neomycin means the neomycin base activity (potency) contained in 1.429 micrograms of the neomycin master standard when dried for 3 hours at 60° C. and a pressure of 5 millimeters or less. term (21) Novobiocin. The "microgram" applied to novobiocin means the novobiocin acid activity (potency) contained in 1.033 micrograms of the novobiocin master standard when dried for 3 hours at 60° C. and a pressure of 5 millimeters or less. (22) Oleandomycin. The term "microgram" applied to oleandomycin means the oleandomycin base activity (potency) contained in 1.176 micrograms of the oleandomycin master standard. (23) Troleandomycin. The term "microgram” applied to troleandomycin means the activity (potency), calculated as the molecular equivalent of the oleandomycin base, contained in 1.2315 micrograms of the troleandomycin master standard. (24) Oxytetracycline. The "microgram" applied to oxytetracycline means the oxytetracycline base activity (potency) contained in 1.13 micrograms of the oxytetracycline master standard. term (32) Dactinomycin. The "microgram" applied to dactinomycin means the dactinomycin activity (potency) contained in 1.000 microgram of the dactinomycin master standard when dried for 3 hours at 60° C. and a pressure of 5 millimeters or less. (33) Candicidin. The term "microgram" applied to candicidin means the candicidin activity (potency) contained in 1.0 microgram of the candicidin master standard when dried for 3 hours at 40° C. and a pressure of 5 millimeters or less. (34) Cephalothin. The term "microgram" applied to cephalothin means the cephalothin activity (potency) contained in 1.056 micrograms of the cephalothin master standard when dried for 3 hours at 60° C. and a pressure of 5 millimeters or less. the methacycline master standard when dried for 3 hours at 60° C. and a pressure of 5 millimeters or less. term term (38) Doxycycline. The "microgram" applied to doxycycline means the doxycycline activity (potency) contained in 1.155 micrograms of the doxycycline master standard. (39) Cephaloridine. The "microgram" applied to cephaloridine means the cephaloridine activity (potency) contained in 1.00806 micrograms of the cephaloridine master standard when dried for 3 hours at 60° C. and a pressure of 5 millimeters or less. (40) Dicloxacillin. "microgram" applied to dicloxacillin means the dicloxacillin activity (potency) contained in 1.087 micrograms of the dicloxacillin master standard. (41) Plicamycin. The term "microgram” applied to plicamycin means the plicamycin activity (potency) contained in 1.000 microgram of the plicamycin master standard when dried for 4 hours at 25° C. and a pressure of 5 millimeters or less. The term (47) Capreomycin. The "microgram" applied to capreomycin means the capreomycin activity (potency) contained in 1.0870 micrograms of the capreomycin master standard when dried for 4 hours at 100° C. and a pressure of 5 millimeters or less. (48) Rifampin. The term "microgram” applied to rifampin means the rifampin activity (potency) contained in 1.0101 |