|
|
|
Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION,
PART 436--TESTS AND METHODS OF ASSAY OF ANTIBIOTIC AND ANTIBIOTIC-CONTAINING DRUGS
|
|||
 |
 | 436.1 | Sterility requirements of items packaged with sterile antibiotic drugs. |
|
|
| 436.2 | Alternative assay methods. |
|
|
| 436.20 | Sterility test methods and procedures. |
|
|
| 436.31 | Equipment and diluents for use in biological testing. |
|
|
| 436.32 | Pyrogen test. |
|
|
| 436.35 | Depressor substances test. |
|
|
| 436.100 | Laboratory equipment. |
|
|
| 436.101 | Solutions. |
|
|
| 436.102 | Culture media. |
|
|
| 436.103 | Test organisms. |
|
|
| 436.104 | Penicillin activity. |
|
|
| 436.105 | Microbiological agar diffusion assay. |
|
|
| 436.106 | Microbiological turbidimetric assay. |
|
|
| 436.200 | Loss on drying. |
|
|
| 436.201 | Moisture determination. |
|
|
| 436.202 | pH. |
|
|
| 436.203 | Crystallinity. |
|
|
| 436.204 | Iodometric assay. |
|
|
| 436.205 | Hydroxylamine colorimetric assay. |
|
|
| 436.206 | Test for metal particles in ophthalmic ointments. |
|
|
| 436.207 | Residue on ignition. |
|
|
| 436.208 | Heavy metals determination. |
|
|
| 436.209 | Melting range or temperature. |
|
|
| 436.210 | Specific rotation. |
|
|
| 436.211 | Identity test by infrared spectrophotometry. |
|
|
| 436.212 | Disintegration test. |
|
|
| 436.213 | Nonaqueous titrations. |
|
|
| 436.214 | Heat stability. |
|
|
| 436.215 | Dissolution test. |
|
|
| 436.216 | High-performance liquid chromatographic assay. |
|
|
| 436.217 | Film-coat rupture test. |
|
|
| 436.300 | Polarimetric assay of carbenicillin indanyl sodium. |
|
|
| 436.301 | Thin layer chromatography identity test for carbenicillin indanyl. |
|
|
| 436.302 | Clindamycin vapor phase chromatography. |
|
|
| 436.303 | Clindamycin content of clindamycin palmitate hydrochloride by vapor phase chromatography. |
|
|
| 436.304 | Clindamycin phosphate vapor phase chromatography. |
|
|
| 436.305 | Thin layer chromatographic identity test for hetacillin. |
|
|
| 436.306 | Lincomycin gas liquid chromatography. |
|
|
| 436.307 | Spectinomycin vapor phase chromatography. |
|
|
| 436.308 | Paper chromatography identity test for tetracyclines. |
|
|
| 436.309 | Anhydrotetracyclines and 4-epianhydrotetracycline. |
|
|
| 436.310 | Thin layer chromatography identity test for mitomycin. |
|
|
| 436.311 | Thin layer chromatography identity test for amoxicillin. |
|
|
| 436.312 | Atomic absorption method for determining the zinc content of zinc bacitracin. |
|
|
| 436.316 | Determination of penicillin G content. |
|
|
| 436.317 | Solubility characteristic test for griseofulvin (ultramicrosize) tablets. |
|
|
| 436.318 | Continuous flow thin layer chromatography identity test. |
|
|
| 436.319 | Thin layer chromatography identity test for bacitracin and bacitracin zinc. |
|
|
| 436.320 | Ferric chloride colorimetric assay. |
|
|
| 436.321 | Griseofulvin gas liquid chromatography. |
|
|
| 436.322 | High-pressure liquid chromatographic assay for anthracycline antibiotics. |
|
|
| 436.323 | Continuous flow thin layer chromatography identity test for cefamandole nafate. |
|
|
| 436.324 | Polarographic analysis of cefamandole. |
|
|
| 436.325 | High pressure liquid chromatography assay for vidarabine. |
|
|
| 436.326 | Thin layer chromatographic identity test for cefoxitin sodium. |
|
|
| 436.327 | Thin layer chromatographic identity test for cyclacillin. |
|
|
| 436.328 | High pressure liquid chromatographic assay for sulfisoxazole acetyl content. |
|
|
| 436.329 | High-pressure liquid chromatographic assay for meclocycline. |
|
|
| 436.330 | Thin layer chromatographic identity test for bacampicillin. |
|
|
| 436.331 | High-pressure liquid chromatographic assay for dactinomycin. |
|
|
| 436.332 | High-pressure liquid chromatographic assay for moxalactam. |
|
|
| 436.333 | Thin layer chromatographic identity test for moxalactam. |
|
|
| 436.334 | High-pressure liquid chromatographic assay for piperacillin. |
|
|
| 436.335 | High-pressure liquid chromatographic assay for chloramphenicol palmitate. |
|
|
| 436.336 | Thin layer chromatographic identity test for azlocillin. |
|
|
| 436.337 | High-pressure liquid chromatographic assay for cephradine. |
|
|
| 436.338 | High-pressure liquid chromatographic assay for cefoperazone. |
|
|
| 436.339 | High-pressure liquid chromatographic assay for bleomycin fractions. |
|
|
| 436.340 | High-pressure liquid chromatographic assay for tetracycline hydrochloride content and 4-epitetracycline hydrochloride content. |
|
|
| 436.341 | High-pressure liquid chromatographic assay for plicamycin. |
|
|
| 436.342 | High-pressure liquid chromatographic assay for cefazolin. |
|
|
| 436.343 | High-pressure liquid chromatographic assay for cefuroxime. |
|
|
| 436.344 | Thin layer chromatographic identity test for cefuroxime. |
|
|
| 436.345 | High-pressure liquid chromatographic assay for ceftizoxime. |
|
|
| 436.346 | High-pressure liquid chromatographic assay for cyclosporine. |
|
|
| 436.347 | High-pressure liquid chromatographic assay for cefoxitin. |
|
|
| 436.348 | High-pressure liquid chromatographic assay for ceforanide. |
|
|
| 436.349 | High-pressure liquid chromatographic assay for L-lysine in ceforanide for injection. |
|
|
| 436.350 | High-performance liquid chromatographic assay for cefonicid. |
|
|
| 436.351 | High-performance liquid chromatographic assay for amoxicillin and clavulanic acid. |
|
|
| 436.352 | High-performance liquid chromatographic assay for determining clavam-2-carboxylate content in clavulanate potassium. |
|
|
| 436.353 | High-performance liquid chromatographic assay for amdinocillin. |
|
|
| 436.354 | High-performance liquid chromatographic assay for ceftriaxone. |
|
|
| 436.355 | High-performance liquid chromatographic assay for ticarcillin-clavulanic acid. |
|
|
| 436.356 | High-performance liquid chromatographic assay for ceftazidime. |
|
|
| 436.357 | Atomic absorption test for sodium carbonate content. |
|
|
| 436.358 | High-performance liquid chromatographic assay for pyridine. |
|
|
| 436.360 | Gel permeation chromatographic assay for high molecular weight polymer. |
|
|
| 436.361 | High-performance liquid chromatographic assay for aztreonam. |
|
|
| 436.362 | Thin-layer chromatographic test for free erythromycin content in erythromycin estolate bulk. |
|
|
| 436.363 | High-performance liquid chromatographic assay for cefmenoxime. |
|
|
| 436.364 | Atomic absorption test for sodium carbonate content of cefmenoxime hydrochloride for injection. |
|
|
| 436.365 | Thin layer chromatographic identity test for rifampin. |
|
|
| 436.366 | High-performance liquid chromatography assay for determining chromatographic purity of vancomycin. |
|
|
| 436.367 | Thin-layer chromatographic identity test for cephalexin hydrochloride. |
|
|
| 436.368 | Thin layer chromatographic identity test for cefprozil. |
|
|
| 436.369 | Thin layer chromatography test for free -isobutylpiperidone content in rifabutin. |
|
|
| 436.370 | Spectrophotometric identity test for rifabutin capsules. |
|
|
| 436.400 | Thin layer chromatographic identity test for iodochlorhydroxyquin. |
|
|
| 436.500 | Penicillin in oil and wax. |
|
|
| 436.503 | Procaine penicillin and buffered crystalline penicillin for aqueous injection. |
|
|
| 436.504 | Penicillin-bacitracin ointment. |
|
|
| 436.505 | Penicillin-streptomycin-bacitracin ointment; penicillin-dihydrostreptomycin-bacitracin ointment; penicillin-streptomycin-bacitracin methylene disalicylate ointment; penicillin-dihydrostreptomycin-bacitracin methylene disalicylate ointment. |
|
|
| 436.506 | Benzathine penicillin G and buffered crystalline penicillin for aqueous injection. |
|
|
| 436.507 | Benzathine - procaine - buffered crystalline penicillins for aqueous injection. |
|
|
| 436.508 | Penicillin - bacitracin - neomycin ointment; penicillin-bacitracin-neomycin in oil. |
|
|
| 436.509 | Procaine penicillin-streptomycin-polymyxin in oil; procaine penicillin-dihydrostreptomycin-polymyxin in oil; procaine penicillin-streptomycin-polymyxin ointment; procaine penicillin - dihydrostreptomycin - polymyxin ointment. |
|
|
| 436.510 | Penicillin-streptomycin-erythromycin ointment; penicillin-dihydro-streptomycin-erythromycin ointment. |
|
|
| 436.511 | Penicillin-streptomycin-bacitracin methylene disalicylate-neomycin ointment; penicillin-dihydrostreptomycin-bacitracin methylene disalicylate-neomycin ointment. |
|
|
| 436.512 | Procaine penicillin G-novobiocin-neomycin-dihydrostreptomycin in oil. |
|
|
| 436.513 | Chlortetracycline troches; tetracycline hydrochloride troches. |
|
|
| 436.514 | Chlortetracycline hydrochloride powder topical; tetracycline hydrochloride powder topical. |
|
|
| 436.515 | Capsules tetracycline and oleandomycin phosphate; capsules tetracycline and troleandomycin; capsules tetracycline hydrochloride and oleandomycin phosphate; capsules tetracycline hydrochloride and troleandomycin. |
|
|
| 436.516 | Tetracycline-neomycin complex powder topical; tetracycline hydrochloride-neomycin sulfate powder topical. |
|
|
| 436.517 | Bacitracin-neomycin tablets; zinc bacitracin-neomycin tablets; bacitracin methylene disalicylate-neomycin tablets. |
|
|
| 436.542 | Acid resistance/dissolution test for enteric-coated erythromycin pellets. |
|
|
| 436.543 | Acid resistance test for pellet-filled doxycycline hyclate capsules. |
|
|
| 436.544 | Dissolution test for pellet-filled doxycycline hyclate capsules. |
|
|
| 436.545 | Acid resistance test for erythromycin particles in tablets. |
![[BACK ]](http://www.access.gpo.gov/su_docs/images/icons/lefticn2.gif){kind=icon}
![[BACK ]](http://www.access.gpo.gov/su_docs/images/icons/content.gif){kind=icon}