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<17> PRESCRIPTION CONTAINER LABELING PF 37(1) Compendial Deferrals for USP35-NF30, First Supplement Monograph Title Monograph Section Scientific Liaison Title, INTRODUCTION, PRESCRIPTION CONTAINER LABEL <17> PRESCRIPTION CONTAINER STANDARDS TO PROMOTE PATIENT UNDERSTANDING, Shawn LABELING PF 37(1) Pg. ONLINE Becker REFERENCES <31> VOLUMETRIC APPARATUS PF USE&mdash;, STANDARDS OF ACCURACY&mdash; Horacio 37(2) Pg. ONLINE Pappa <111> DESIGN AND ANALYSIS OF STEPS PRECEDING THE CALCULATION OF POTENCY, Tina Morris BIOLOGICAL ASSAYS PF 36(4) Pg. 952 EXPERIMENTAL ERROR AND TESTS OF ASSAY VALIDITY INTRODUCTION, LIMITS OF ELEMENTAL IMPURITIES, OPTIONS FOR DESCRIBING LIMITS OF ELEMENTAL <232> ELEMENTAL IMPURITIES-- IMPURITIES, ANALYTICAL PROCEDURES, SPECIATION, Kahkashan LIMITS PF 37(3) Pg. ONLINE ROUTES OF EXPOSURE, DRUG PRODUCTS, DRUG Zaidi SUBSTANCE AND EXCIPIENTS, ANALYTICAL TESTING, Title INTRODUCTION, COMPENDIAL PROCEDURES 1 AND 2, ALTERNATE PROCEDURE VALIDATION, LIMIT PROCEDURES, QUANTITATIVE PROCEDURES, Title, <233> ELEMENTAL IMPURITIES - ALTERNATIVE PROCEDURE VALIDATION REQUIREMENTS, Kahkashan PROCEDURES PF 37(3) Pg. ONLINE Zaidi VALIDATION OF LIMIT PROCEDURES, VALIDATION OF QUANTITATIVE PROCEDURES, REFEREE PROCEDURES 1 AND 2, CALCULATIONS AND REPORTING <621> CHROMATOGRAPHY PF 37(3) SYSTEM SUITABILITY Horacio Pg. ONLINE Pappa <797> PHARMACEUTICAL DEFINITIONS, IMMEDIATE-USE CSPS, HAZARDOUS COMPOUNDING--STERILE DRUGS AS CSPS, RADIOPHARMACEUTICALS AS CSPS, Shawn Becker PREPARATIONS PF 36(3) Pg. 714 ENVIRONMENTAL QUALITY AND CONTROL Title, INTRODUCTION, LIMITS OF ELEMENTAL CONTAMINANTS, OPTIONS FOR COMPLIANCE WITH THE <2232> ELEMENTAL CONTAMINANTS LIMITS OF ELEMENTAL CONTAMINANTS, ANALYTICAL IN DIETARY SUPPLEMENTS PF 36(1) Gabriel PROCEDURES FOR TOTAL ELEMENTAL CONTAMINANTS, Giancaspro Pg. 258 ANALYTICAL PROCEDURE FOR INORGANIC ARSENIC, ANALYTICAL PROCEDURE FOR METHYLMERCURY Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP ALFUZOSIN HYDROCHLORIDE Alfuzosin Hydrochloride RS, ADDITIONAL EXTENDED-RELEASE TABLETS PF 36(4) Domenick REQUIREMENTS/USP Reference Standards <11>/USP Vicchio Pg. 889 Alfuzosin System Suitability Mixture RS&mdash;Alfuzosin hydrochloride containing approximately 0.4% of each of the following impurities: Impurity A: [N-{3-[(4-amino- 6,7-dimethoxyquinazolin-2- yl)(methyl)amino]propyl}furan-2- carboxamide](C19H23N5O4385.42) Impurity D: [N-(4- amino-6,7-dimethoxyquinazolin-2-yl)-N-methylpropane- 1,3-diamine](C14H21N5O2291.35) Title, DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL AMIODARONE HYDROCHLORIDE ORAL REQUIREMENTS/Labeling, ADDITIONAL Rick Schnatz SUSPENSION PF 37(1) Pg. ONLINE REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amiodarone Hydrochloride RS Title, DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH <791>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL AMLODIPINE ORAL SUSPENSION PF REQUIREMENTS/Labeling, ADDITIONAL Rick Schnatz 37(1) Pg. ONLINE REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amlodipine Besylate RS IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound C RS [(4S)-2-[5-(4- hydroxyphenyl)-3,6-dioxopiperazin-2-yl]-5,5- dimethylthiazolidine-4-carboxylic acid; amoxicillin rearrangement product](C16H19N3O5S365.40), ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound D RS [(4S)-2- AMOXICILLIN CAPSULES PF 36(4) Pg. {[(R)-2-amino-2-(4- Ahalya Wise 892 hydroxyphenyl)acetamido](carboxy)methyl}-5,5- dimethylthiazolidine-4-carboxylic acid; amoxicillin open ring](C16H21N3O6S383.42), ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound G RS [(2S,5R,6R)-6-{(R)- 2-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-2-(4- hydroxyphenyl)acetamido}-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylic acid; d- hydroxyphenylglycylamoxicillin](C24H26N4O7S514.55) IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound D and E Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards AMOXICILLIN FOR ORAL SUSPENSION <11>/ USP Amoxicillin Related Compound G RS Ahalya Wise PF 36(4) Pg. 894 (2S,5R,6R)-6-{(R)-2-[[(R)-2-amino-2-(4- hydroxyphenyl)acetamido]-2-(4- hydroxyphenyl)acetamido}-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylic acid; d- hydroxyphenylglycylamoxicillin](C24H26N4O7S514.55) IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound A RS [(2S,5R,6R)-6-amino- 3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2- carboxylic acid; 6-aminopenicillanic AMOXICILLIN TABLETS PF 36(4) Pg. acid](C8H12N2O3S216.26), ADDITIONAL Ahalya Wise 896 REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound D RS [(4S)-2-{[(R)-2- amino-2-(4-hydroxyphenyl)acetamido](carboxy)methyl}- 5,5-dimethylthiazolidine-4-carboxylic acid; amoxicillin open ring](C16H21N3O6S383.42) IMPURITIES/Organic Impurities, ADDITIONAL AMOXICILLIN AND CLAVULANATE REQUIREMENTS/USP Reference Standards <11>/USP POTASSIUM FOR ORAL SUSPENSION Amoxicillin Related Compound A RS, ADDITIONAL Ahalya Wise PF 36(4) Pg. 899 REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound D RS IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP AMOXICILLIN AND CLAVULANATE Amoxicillin Related Compound A RS, ADDITIONAL Ahalya Wise POTASSIUM TABLETS PF 36(4) Pg. 901 REQUIREMENTS/USP Reference Standards <11>/USP Amoxicillin Related Compound D RS Title, Chemical Info/Chemical Structure, Chemical Info/C16H26O5, Chemical Info/298.37, Chemical Info/(3R,5aS,6R,8aS,9R,10S,12R,12aR)-Decahydro-10- methoxy-3,6,9-trimethyl-3,12-epoxy-12H-pyrano[4.3-j]- 1,2-benzodioxepin, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Inorganic Impurities/Residue on Ignition <281>, IMPURITIES/Inorganic Impurities/Heavy Metals, Method II <231>, IMPURITIES/Organic Impurities/Procedure 1: Analysis of Cyclohexanone Propanal Derivative and Furoisochromen Derivative by TLC, IMPURITIES/Organic Impurities/Procedure 2: Analysis of Artemether Related Compound A, Artemether Related Compound B, and Any ARTEMETHER PF 36(2) Pg. 377 Behnam Other Individual Impurity by HPLC, SPECIFIC Davani TESTS/Optical Rotation, Specific Rotation <781S>, SPECIFIC TESTS/Color of solution, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Artemether RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Artemether Related Compound A RS [(3R,5aS,6R,8aS,9R,12R,12aR)- Decahydro-10-hydroxy-3,6,9-trimethyl-3,12-epoxy-12H- pyrano[4,3-j]-1,2-benzodioxepin](C15H24O5284.35), ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Artemether Related Compound B RS [(3R,5aS,6R,8aS,9R,10R,12R,12aR)-Decahydro-10- methoxy-3,6,9-trimethyl-3,12-epoxy-12H-pyrano[4,3-j]- 1,2-benzodioxepin](C16H26O5298.37) Title, DEFINITION/Introduction, IDENTIFICATION/A. Thin Layer Chromatography, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities/Procedure 1: Impurities of Artemether, IMPURITIES/Organic Impurities/Procedure 2: Impurities of Lumefantrine, IMPURITIES/Organic Impurities/Acceptance criteria, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Artemether RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Artemether Related ARTEMETHER AND LUMEFANTRINE Compound A RS [(3R,5aS,6R,8aS,9R,12R,12aR)- Behnam TABLETS PF 36(2) Pg. 379 Davani Decahydro-10-hydroxy-3,6,9-trimethyl-3,12-epoxy-12H- pyrano[4,3-j]-1,2-benzodioxepin](C15H24O5284.35), ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Artemether Related Compound B RS [(3R,5aS,6R,8aS,9R,10R,12R,12aR)-Decahydro-10- methoxy-3,6,9-trimethyl-3,12-epoxy-12H-pyrano[4,3-j]- 1,2-benzodioxepin](C16H26O5298.37), ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lumefantrine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Lumefantrine Related Compound A RS [(RS, Z)-2-(Dibutylamino)-2-(2,7- dichloro-9-(4-chlorobenzylidene)-9H-fluoren-4- yl)ethanol](C30H32Cl3NO528.94) Title, DEFINITION/Introduction, IDENTIFICATION/A., ASSAY/Articaine Hydrochloride, ASSAY/Epinephrine, PERFORMANCE TESTS/Deliverable Volume <698>, IMPURITIES/Organic Impurities, Limit of Articaine Related Compounds, IMPURITIES/Organic Impurities, Limit of Epinephrine Related Compounds, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Bacterial Endotoxin Test <85>, SPECIFIC TESTS/Sterility <71>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC ARTICAINE HYDROCHLORIDE AND TESTS/Other Requirements, ADDITIONAL EPINEPHRINE INJECTION PF 37(3) Pg. Domenick REQUIREMENTS/Packaging and Storage, ADDITIONAL Vicchio ONLINE REQUIREMENTS/USP Reference Standards <11>/USP Articaine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Articaine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards
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