Food and Drug Administration, HHS Pt. 436
records after the first 2 years of the Subpart F—Chemical Tests for Specific holding period. Antibiotics 436.300 Polarimetric assay of carbenicillin PART 436—TESTS AND METHODS OF indanyl sodium. ASSAY OF ANTIBIOTIC AND AN- 436.301 Thin layer chromatography identity TIBIOTIC-CONTAINING DRUGS test for carbenicillin indanyl. 436.302 Clindamycin vapor phase chroma- tography. Sec. 436.303 Clindamycin content of clindamycin palmitate hydrochloride by vapor phase Subpart A—Definitions; Interpretations; chromatography. Requirements 436.304 Clindamycin phosphate vapor phase chromatography. 436.1 Sterility requirements of items pack- 436.305 Thin layer chromatographic identity aged with sterile antibiotic drugs. test for hetacillin. 436.2 Alternative assay methods. 436.306 Lincomycin gas liquid chroma- tography. Subpart B—Sterility Test Methods 436.307 Spectinomycin vapor phase chroma- tography. 436.20 Sterility test methods and proce- 436.308 Paper chromatography identity test dures. for tetracyclines. 436.309 Anhydrotetracyclines and 4-epian- Subpart C—Biological Test Methods hydrotetracycline. 436.310 Thin layer chromatography identity 436.31 Equipment and diluents for use in bi- test for mitomycin. ological testing. 436.311 Thin layer chromatography identity 436.32 Pyrogen test. test for amoxicillin. 436.35 Depressor substances test. 436.312 Atomic absorption method for deter- mining the zinc content of zinc baci- Subpart D—Microbiological Assay tracin. 436.316 Determination of penicillin G con- Methods tent. 436.100 Laboratory equipment. 436.317 Solubility characteristic test for griseofulvin (ultramicrosize) tablets. 436.101 Solutions. 436.318 Continuous flow thin layer chroma- 436.102 Culture media. tography identity test. 436.103 Test organisms. 436.319 Thin layer chromatography identity 436.104 Penicillin activity. test for bacitracin and bacitracin zinc. 436.105 Microbiological agar diffusion assay. 436.320 Ferric chloride colorimetric assay. 436.106 Microbiological turbidimetric assay. 436.321 Griseofulvin gas liquid chroma- tography. Subpart E—General Chemical Tests for 436.322 High–pressure liquid Antibiotics chromatographic assay for anthracycline antibiotics. 436.200 Loss on drying. 436.323 Continuous flow thin layer chroma- 436.201 Moisture determination. tography identity test for cefamandole 436.202 pH. nafate. 436.203 Crystallinity. 436.324 Polarographic analysis of 436.204 Iodometric assay. cefamandole. 436.205 Hydroxylamine colorimetric assay. 436.325 High pressure liquid chroma- 436.206 Test for metal particles in ophthal- tography assay for vidarabine. mic ointments. 436.326 Thin layer chromatographic identity 436.207 Residue on ignition. test for cefoxitin sodium. 436.327 Thin layer chromatographic identity 436.208 Heavy metals determination. test for cyclacillin. 436.209 Melting range or temperature. 436.328 High pressure liquid 436.210 Specific rotation. chromatographic assay for sulfisoxazole 436.211 Identity tests by infrared acetyl content. spectrophotometry. 436.329 High-pressure liquid 436.212 Disintegration test. chromatographic assay for meclocycline. 436.213 Nonaqueous titrations. 436.330 Thin layer chromatographic identity 436.214 Heat stability. test for bacampicillin. 436.215 Dissolution test. 436.331 High-pressure liquid 436.216 High–performance liquid chromatographic assay for chromatographic assay. dactinomycin. 436.217 Film-coat rupture test. 436.332 High-pressure liquid
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chromatographic assay for moxalactam. free erythromycin content in erythro- 436.333 Thin layer chromatographic identity mycin estolate bulk. test for moxalactam. 436.363 High-performance liquid 436.334 High-pressure liquid chromatographic assay for cefmenoxime. chromatographic assay for piperacillin. 436.364 Atomic absorption test for sodium 436.335 High-pressure liquid carbonate content of cefmenoxime hy- chromatographic assay for chlor- drochloride for injection. amphenicol palmitate. 436.365 Thin layer chromatographic identity 436.336 Thin layer chromatographic identity test for rifampin. test for azlocillin. 436.366 High-performance liquid chroma- 436.337 High-pressure liquid tography assay for determining chromatographic assay for cephradine. chromatographic purity of vancomycin. 436.338 High-pressure liquid 436.367 Thin-layer chromatographic identity chromatographic assay for cefoperazone. test for cephalexin hydrochloride. 436.339 High-pressure liquid 436.368 Thin layer chromatographic identity chromatographic assay for bleomycin test for cefprozil. fractions. 436.369 Thin layer chromatography test for 436.340 High-pressure liquid free N-isobutylpiperidone content in chromatographic assay for tetracycline rifabutin. hydrochloride content and 4– 436.370 Spectrophotometric identity test for epitetracycline hydrochloride content. rifabutin capsules. 436.341 High-pressure liquid chromatographic assay for plicamycin. Subpart G—Chemical Tests for 436.342 High-pressure liquid Nonantibiotic Active Ingredients chromatographic assay for cefazolin. 436.343 High-pressure liquid 436.400 Thin layer chromatographic identity chromatographic assay for cefuroxime. test for iodochlorhydroxyquin. 436.344 Thin layer chromatographic identity test for cefuroxime. Subpart H—Tests for Specific Antibiotic 436.345 High-pressure liquid Dosage Forms chromatographic assay for ceftizoxime. 436.346 High-pressure liquid 436.500 Penicillin in oil and wax. chromatographic assay for cyclosporine. 436.503 Procaine penicillin and buffered 436.347 High-pressure liquid crystalline penicillin for aqueous injec- chromatographic assay for cefoxitin. tion. 436.348 High-pressure liquid 436.504 Penicillin-bacitracin ointment. chromatographic assay for ceforanide. 436.505 Penicillin-streptomycin-bacitracin 436.349 High-pressure liquid ointment; penicillin-dihydrostrepto- chromatographic assay for L-lysine in mycin-bacitracin ointment; penicillin- ceforanide for injection. streptomycin-bacitracin methylene disa- 436.350 High-performance liquid licylate ointment; penicillin-dihydro- chromatographic assay for cefonicid. streptomycin-bacitracin methylene disa- 436.351 High-performance liquid licylate ointment. chromatographic assay for amoxicillin 436.506 Benzathine penicillin G and buffered and clavulanic acid. crystalline penicillin for aqueous injec- 436.352 High-performance liquid tion. chromatographic assay for determining 436.507 Benzathine-procaine-buffered crys- clavam-2-carboxylate content in talline penicillins for aqueous injection. clavulanate potassium. 436.508 Penicillin - bacitracin - neomycin 436.353 High-performance liquid ointment; penicillin-bacitracin-neomycin chromatographic assay for amdinocillin. in oil. 436.354 High-performance liquid 436.509 Procaine penicillin-streptomycin- chromatographic assay for ceftriaxone. polymyxin in oil; procaine penicillin-di- 436.355 High–performance liquid hydrostreptomycin-polymyxin in oil; chromatographic assay for ticarcillin– procaine penicillin-streptomycin-poly- clavulanic acid. myxin ointment; procaine penicillin-di- 436.356 High–performance liquid hydrostreptomycin-polymyxin ointment. chromatographic assay for ceftazidime. 436.510 Penicillin - streptomycin - erythro- 436.357 Atomic absorption test for sodium mycin ointment; penicillin-dihydro- carbonate content. streptomycin - erythromycin ointment. 436.358 High–performance liquid 436.511 Penicillin-streptomycin-bacitracin chromatographic assay for pyridine. methylene disalicylate-neomycin oint- 436.360 Gel permeation chromatographic ment; penicillin-dihydrostreptomycin- assay for high molecular weight polymer. bacitracin methylene disalicylate-neo- 436.361 High–performance liquid mycin ointment. chromatographic assay for aztreonam. 436.512 Procaine penicillin G-novobiocin-ne- 436.362 Thin-layer chromatographic test for omycin-dihydrostreptomycin in oil.
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436.513 Chlortetracycline troches; tetra- graphs of this chapter may be used, cycline hydrochloride troches. provided the results obtained are of 436.514 Chlortetracycline hydrochloride equivalent accuracy. However, only the powder topical; tetracycline hydro- chloride powder topical. results obtained from the official 436.515 Capsules tetracycline and methods designated in the individual oleandomycin phosphate; capsules tetra- monographs are conclusive. cycline and troleandomycin; capsules tetracycline hydrochloride and Subpart B—Sterility Test Methods oleandomycin phosphate; capsules tetra- cycline hydrochloride and troleandomycin. § 436.20 Sterility test methods and pro- 436.516 Tetracycline-neomycin complex cedures. powder topical; tetracycline hydro- (a) Laboratory facilities. The test must chloride-neomycin sulfate powder topi- be performed using aseptic techniques cal. in an area as free from contamination 436.517 Bacitracin-neomycin tablets; zinc bacitracin-neomycin tablets; bacitracin as is possible to achieve. Testing methylene disalicylate-neomycin tab- should not be conducted under direct lets. exposure to ultraviolet light or in 436.542 Acid resistance/dissolution test for areas under aerosol treatment. Envi- enteric-coated erythromycin pellets. ronmental tests to assess the suit- 436.543 Acid resistance test for pellet-filled ability of testing conditions should be doxycycline hyclate capsules. made frequently enough to assure the 436.544 Dissolution test for pellet-filled doxycycline hyclate capsules. validity of test results. 436.545 Acid resistance test for erythro- (b) Equipment and reagents—(1) Bac- mycin particles in tablets. terial membrane filter. The filter has a nominal porosity of 0.45 micron±0.02 AUTHORITY: 21 U.S.C. 357. micron, a diameter of approximately 47 SOURCE: 39 FR 18944, May 30, 1974, unless millimeters, and a flowrate of 55 milli- otherwise noted. liters to 75 milliliters of distilled water passing each square centimeter of fil- Subpart A—Definitions; ter area per minute with a differential Interpretations; Requirements pressure of 70 centimeters of mercury at 25° C. § 436.1 Sterility requirements of items (2) Penicillinase solutions. When the packaged with sterile antibiotic drugs. amount of penicillinase to be used is specified in terms of Levy units, use a (a) Diluents packaged in combination penicillinase solution standardized in with sterile antibiotic drugs. If a sterile terms of Levy units. One Levy unit of antibiotic drug is packaged in com- penicillinase inactivates 59.3 units of bination with an immediate container penicillin G in 1 hour at 25° C. and at a of a diluent, the immediate container pH of 7.0 in a phosphate buffered solu- of diluent shall be sterile when tested tion of a pure alkali salt of penicillin G by the method prescribed in when the substrate is in sufficient con- § 436.20(e)(1). centration to maintain a zero order re- (b) Dispensers packaged in combination action. with sterile antibiotic drugs. If a sterile (c) Culture media. Use ingredients antibiotic drug is packaged in com- that conform to the standards pre- bination with a dispenser, such dis- scribed by the U.S.P. or N.F. In lieu of penser shall be sterile when tested by preparing the media from the individ- the method prescribed in § 436.20(e)(1). ual ingredients, they may be made [39 FR 18944, May 30, 1974, as amended at 41 from dehydrated mixtures which, when FR 46852, Oct. 26, 1976] reconstituted with distilled water, have the same or equivalent composi- § 436.2 Alternative assay methods. tion as such media and have growth- Alternative assay methods (including promoting buffering, and oxygen ten- automated procedures) employing the sion-controlling properties equal to or same basic chemistry or microbiology better than such media. The pH of each as the official methods described in medium should be adjusted with 2N hy- this part and in the individual mono- drochloric acid or sodium hydroxide
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