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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter D - Drugs for Human Use |
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Part 436 - TESTS AND METHODS OF ASSAY OF ANTIBIOTIC AND ANTIBIOTIC-CONTAINING DRUGS |
| Subpart A - Definitions; Interpretations; Requirements |
| § 436.1 - Sterility requirements of items packaged with sterile antibiotic drugs. |
| § 436.2 - Alternative assay methods. |
| Subpart B - Sterility Test Methods |
| § 436.20 - Sterility test methods and procedures. |
| Subpart C - Biological Test Methods |
| § 436.31 - Equipment and diluents for use in biological testing. |
| § 436.32 - Pyrogen test. |
| § 436.35 - Depressor substances test. |
| Subpart D - Microbiological Assay Methods |
| § 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. |
| Subpart E - General Chemical Tests for Antibiotics |
| § 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. |
| Subpart F - Chemical Tests for Specific Antibiotics |
| § 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 N-isobutylpiperidone content in rifabutin. |
| § 436.370 - Spectrophotometric identity test for rifabutin capsules. |
| Subpart G - Chemical Tests for Nonantibiotic Active Ingredients |
| § 436.400 - Thin layer chromatographic identity test for iodochlorhydroxyquin. |
| Subpart H - Tests for Specific Antibiotic Dosage Forms |
| § 436.500 - Penicillin in oil and wax. |
| § 436.503 - Procaine penicillin and buffered crystalline penicillin for aqueous injection. |
| § 436.504 - Penicillin-bacitracin 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. |
| § 436.510 - 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. |
| § 436.516 - 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. |