| Chapter Title |
Summary Status |
Most Recent/Proposed PF |
Official/Proposed Official Date |
Expert Committee |
|
<1> INJECTIONS
|
Official in PF
|
32(3)
|
USP 30 1S
|
PPI
|
|
<11> REFERENCE STANDARDS
|
Official in PF
|
32(1)
|
USP 29 2S
|
RS
|
|
<13> CONCORDANCE OF FOREIGN PHARMACOPEIAL TESTS AND ASSAYS
|
New in PF
|
pre-1998
|
to be canceled
|
GC
|
|
<16> AUTOMATED METHODS OF ANALYSIS
|
Official
|
26(3)
|
USP 23
|
GC
|
|
<21> THERMOMETERS
|
Official
|
pre-1998
|
USP 23
|
GC
|
|
<31> VOLUMETRIC APPARATUS
|
Official
|
26(3)
|
USP 24
|
GC
|
|
<41> WEIGHTS AND BALANCES
|
Official in PF
|
32(6) or 33(1)
|
30-1S
(or 31)
|
GC
|
|
<51> ANTIMICROBIAL EFFECTIVENESS TESTING
|
Official
|
25(1)
|
USP 25
|
MSA
|
|
<55> BIOLOGICAL INDICATORS--RESISTANCE PERFORMANCE TESTS
|
Official in PF
|
30(1)
|
USP 32
|
MSA
|
|
<61> MICROBIAL LIMIT TESTS
|
Official in PF
|
29(5)
|
USP 29 2S
|
MSA
|
|
<62> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS; TESTS FOR SPECIFIED MICROORGANISMS
|
New in PF
|
29(5)
|
USP 29 2S
|
MSA
|
|
<71> STERILITY TESTS
|
Official
|
26(4)
|
USP 27
|
MSA
|
|
<81> ANTIBIOTICS--ANTIMICROBIAL ASSAYS
|
Official
|
30(3)
|
USP 28 1S
|
MDANT
|
|
<85> BACTERIAL ENDOTOXINS TEST
|
Official
|
26(1)
|
USP 26 2S
|
MSA
|
|
<87> BIOLOGICAL REACTIVITY TESTS, IN VITRO
|
Official
|
pre-1998
|
USP 23
|
GTMDB
|
|
<88> BIOLOGICAL REACTIVITY TESTS, IN VIVO
|
Official
|
pre-1998
|
USP 23
|
GTMDB
|
|
<91> CALCIUM PANTOTHENATE ASSAY
|
Official
|
pre-1998
|
USP 26 2S
|
DSN
|
|
<111> DESIGN AND ANALYSIS OF BIOLOGICAL ASSAYS
|
Official
|
pre-1998
|
USP 32
|
STAT
|
|
<115> DEXPANTHENOL ASSAY
|
Official
|
pre-1998
|
pre-USP 23
|
DSN
|
|
<121> INSULIN ASSAYS
|
Official
|
30(5)
|
USP 32
|
BBPP
|
|
<141> PROTEIN--BIOLOGICAL ADEQUACY TEST
|
Official
|
pre-1998
|
pre-USP 23
|
BBPP
|
|
<151> PYROGEN TEST
|
Official
|
pre-1998
|
pre-USP 16
|
MSA
|
|
<161> TRANSFUSION AND INFUSION ASSEMBLIES AND SIMILAR MEDICAL DEVICES
|
Official
|
pre-1998
|
USP 23
|
GTMDB
|
|
<171> VITAMIN B12 ACTIVITY ASSAY
|
Official
|
pre-1998
|
pre-USP 23
|
DSN
|
|
<181> IDENTIFICATION--ORGANIC NITROGENOUS BASES
|
Official
|
pre-1998
|
pre-USP 23
|
GC
|
|
<191> IDENTIFICATION TESTS--GENERAL
|
Official
|
27(6)
|
USP 25 2S
|
GC
|
|
<193> IDENTIFICATION--TETRACYCLINES
|
Official
|
pre-1998
|
pre-USP 23
|
MDANT
|
|
<197> SPECTROPHOTOMETRIC IDENTIFICATION TESTS
|
Official
|
29(3)
|
USP 27 1S
|
GC
|
|
<201> THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST
|
Official
|
28(4)
|
USP 26 1S
|
GC
|
|
<206> ALUMINUM
|
Official
|
25(5)
|
USP 24
|
GC
|
|
<211> ARSENIC
|
Official
|
pre-1998
|
USP 23
|
GC
|
|
<221> CHLORIDE AND SULFATE
|
Official
|
25(2)
|
USP 24
|
GC
|
|
<223> DIMETHYLANILINE
|
Official
|
25(2)
|
USP 24
|
MDANT
|
|
<226> 4-EPIANHYDROTETRACYCLINE
|
Official
|
pre-1998
|
pre-USP 23
|
MDANT
|
|
<231> HEAVY METALS
|
Official in PF
|
32(3)
|
USP 30
|
GC
|
|
<241> IRON
|
Official
|
pre-1998
|
pre-USP 23
|
GC
|
|
<251> LEAD
|
Official
|
pre-1998
|
USP 23
|
GC
|
|
<261> MERCURY
|
Official
|
pre-1998
|
pre-USP 23
|
GC
|
|
<267> POROSIMETRY BY MERCURY INTRUSION
|
New in PF
|
31(3)
|
USP 31
|
EGC
|
|
<271> READILY CARBONIZABLE SUBSTANCES TEST
|
Official
|
pre-1998
|
pre-USP 23
|
GC
|
|
<281> RESIDUE ON IGNITION
|
Official in PF
|
31(5)
|
USP 29 2S
|
GC
|
|
<291> SELENIUM
|
Official
|
pre-1998
|
USP 23
|
GC
|
|
<301> ACID-NEUTRALIZING CAPACITY
|
Official
|
30(3)
|
USP 28 1S
|
GC
|
|
<311> ALGINATES ASSAY
|
Official in PF
|
32(2)
|
USP 30 1S
|
EGC
|
|
<331> AMPHETAMINE ASSAY
|
Official
|
pre-1998
|
pre-USP 23
|
MDPP
|
|
<341> ANTIMICROBIAL AGENTS-CONTENT
|
Official
|
30(5)
|
USP 29 1S
|
MDAA
|
|
<345> ASSAY FOR CITRIC ACID/CITRATE AND PHOSPHATE
|
Official
|
32(1)
|
USP 29
|
GC
|
|
<351> ASSAY FOR STEROIDS
|
Official
|
pre-1998
|
pre-USP 23
|
MDPS
|
|
<361> BARBITURATE ASSAY
|
Official
|
pre-1998
|
pre-USP 23
|
MDPP
|
|
<365> BIOTIN ASSAY
|
New in PF
|
pre-1998
|
USP 32
|
DSN
|
|
<371> COBALAMIN RADIOTRACER ASSAY
|
Official
|
pre-1998
|
pre-USP 23
|
RMI
|
|
<381> ELASTOMERIC CLOSURES FOR INJECTIONS
|
Official in PF
|
30(1)
|
USP 32
|
PPI
|
|
<386> ENVIRONMENT SENSITIVE PREPARATIONS
|
New in PF
|
30(5)
|
USP 32
|
PS
|
|
<391> EPINEPHRINE ASSAY
|
Official
|
pre-1998
|
pre-USP 23
|
AER
|
|
<401> FATS AND FIXED OILS
|
Official in PF
|
31(4)
|
USP 27 1S
|
EGC
|
|
<411> FOLIC ACID ASSAY
|
Official
|
28(3)
|
USP 23
|
DSN
|
|
<425> IODOMETRIC ASSAY--ANTIBIOTICS
|
Official
|
pre-1998
|
pre-USP 23
|
MDANT
|
|
<429> LIGHT DIFFRACTION MEASUREMENT OF PARTICLE SIZE
|
Official in PF
|
31(4)
|
USP 27 1S
|
GC
|
|
<431> METHOXY DETERMINATION
|
Official
|
pre-1998
|
pre-USP 23
|
EGC
|
|
<441> NIACIN OR NIACINAMIDE ASSAY
|
Official
|
pre-1998
|
pre-USP 23
|
DSN
|
|
<451> NITRITE TITRATION
|
Official
|
pre-1998
|
pre-USP 23
|
GC
|
|
<461> NITROGEN DETERMINATION
|
Official
|
25(5)
|
USP 24
|
GC
|
|
<466> ORDINARY IMPURITIES
|
Official
|
32(5)
|
USP 30 2S
|
GC
|
|
<467> ORGANIC VOLATILE IMPURITIES
|
Official in PF
|
32(5)
|
USP 30 1S
|
GC
|
|
<471> OXYGEN FLASK COMBUSTION
|
Official
|
25(1)
|
USP 24
|
GC
|
|
<481> RIBOFLAVIN ASSAY
|
Official
|
pre-1998
|
pre-USP 23
|
DSN
|
|
<501> SALTS OF ORGANIC NITROGENOUS BASES
|
Official
|
pre-1998
|
pre-USP 23
|
GC
|
|
<507> SAMPLING
|
New in Development
|
n/a
|
USP 32
|
GC
|
|
<511> SINGLE-STEROID ASSAY
|
Official
|
pre-1998
|
USP 23
|
MDPS
|
|
<515> SMALL PARTICLE CHARACTERIZATION
|
New in Development
|
n/a
|
USP 32
|
EGC
|
|
<521> SULFONAMIDES
|
Official
|
pre-1998
|
pre-USP 23
|
MDAA
|
|
<525> SULFUR DIOXIDE
|
New in Development
|
32(6)
|
USP 31
|
EGC
|
|
<531> THIAMINE ASSAY
|
Official
|
pre-1998
|
pre-USP 23
|
DSN
|
|
<541> TITRIMETRY
|
Official
|
pre-1998
|
USP 23
|
GC
|
|
<551> ALPHA TOCOPHEROL ASSAY
|
Official
|
pre-1998
|
pre-USP 23
|
DSN
|
|
<561> ARTICLES OF BOTANICAL ORIGIN
|
Official
|
27(5)
|
USP 25 1S
|
DSB
|
|
<563> IDENTIFICATION OF ARTICLES OF BOTANICAL ORIGIN
|
Official
|
28(2)
|
USP 23
|
DSB
|
|
<565> BOTANICAL EXTRACTS
|
Official
|
28(2)
|
USP 24
|
DSB
|
|
<571> VITAMIN A ASSAY
|
Official
|
30(4)
|
USP 28 1S
|
DSN
|
|
<581> VITAMIN D ASSAY
|
Official
|
pre-1998
|
USP 24
|
DSN
|
|
<591> ZINC DETERMINATION
|
Official
|
pre-1998
|
pre-USP 23
|
GC
|
|
<601> AEROSOLS, NASAL SPRAYS, METERED-DOSE INHALERS, AND DRY POWDER INHALERS
|
Official
|
30(4)
|
USP 28 1S
|
AER
|
|
<611> ALCOHOL DETERMINATION
|
Official in PF
|
32(3)
|
USP 30 1S
|
GC
|
|
<616> BULK DENSITY AND TAPPED DENSITY
|
Official in PF
|
31(3)
|
USP 23
|
EGC
|
|
<621> CHROMATOGRAPHY
|
Official in PF
|
32(4)
|
USP 30 2S
|
GC
|
|
<625> CLARITY AND DEGREE OF OPALESCENCE OF LIQUIDS
|
New in PF
|
26(6)
|
USP 32
|
GC
|
|
<627> DEGREE OF COLOR OF LIQUIDS
|
New in PF
|
26(6)
|
USP 32
|
GC
|
|
<631> COLOR AND ACHROMICITY
|
Official
|
26(4)
|
USP 24
|
GC
|
|
<636> COMPACTABILITY TEST
|
New in Development
|
n/a
|
USP 32
|
EGC
|
|
<641> COMPLETENESS OF SOLUTION
|
Official
|
pre-1998
|
pre-USP 23
|
GC
|
|
<643> TOTAL ORGANIC CARBON
|
Official
|
30(5)
|
USP 26 2S
|
PW
|
|
<644> CONDUCTIVITY
|
New in PF
|
31(3)
|
USP 32
|
PW
|
|
<645> WATER CONDUCTIVITY
|
Official
|
30(4)
|
USP 28 1S
|
PW
|
|
<651> CONGEALING TEMPERATURE
|
Official
|
25(6)
|
USP 24
|
EGC
|
|
<660> CONTAINER - GLASS
|
New in PF
|
32(4)
|
USP 30 2S
|
|
|
<661> CONTAINERS
|
Official in PF
|
32(4)
|
USP 30 2S
|
PS
|
|
<662> CONTAINERS -- METALS
|
New in Development
|
n/a
|
USP 32
|
PS
|
|
<670> CONTAINERS -- AUXILIARY COMPONENTS
|
New in Development
|
n/a
|
USP 32
|
PS
|
|
<671> CONTAINERS--PERMEATION
|
Official
|
32(4)
|
USP 30 2S
|
PS
|
|
<681> REPACKAGING INTO SINGLE-UNIT CONTAINERS AND UNIT-DOSE CONTAINERS FOR NONSTERILE SOLID AND LIQUID DOSAGE FORMS
|
New in PF
|
32(4)
|
USP 30 2S
|
PS
|
|
<691> COTTON
|
Official
|
pre-1998
|
pre-USP 23
|
GTMDB
|
|
<695> CRYSTALLINITY
|
Official
|
pre-1998
|
USP 23
|
GC
|
|
<696> CRYSTALLINITY DETERMINATION BY SOLUTION CALORIMETRY
|
Official
|
29(1)
|
pre-USP 23
|
GC
|
|
<698> DELIVERABLE VOLUME
|
Official
|
29(6)
|
USP 27 2S
|
PDF
|
|
<699> DENSITY OF SOLIDS
|
Official in PF
|
31(3)
|
USP 23
|
EGC
|
|
<701> DISINTEGRATION
|
Official
|
31(1)
|
USP 29 1S
|
BPC
|
|
<711> DISSOLUTION
|
Official in PF
|
31(6)
|
USP 29 1S
|
BPC
|
|
<721> DISTILLING RANGE
|
Official
|
32(4)
|
USP 30 2S
|
GC
|
|
<724> DRUG RELEASE
|
Official
|
31(1)
|
USP 29 1S
|
BPC
|
|
<726> ELECTROPHORESIS
|
Official
|
pre-1998
|
pre-USP 23
|
GC
|
|
<727> CAPILLARY ELECTROPHORESIS
|
Official
|
25(6)
|
USP 24
|
GC
|
|
<729> GLOBULE SIZE DISTRIBUTION IN LIPID INJECTABLE EMULSIONS
|
New in PF
|
31(5)
|
USP 30
|
PPI
|
|
<730> PLASMA SPECTROCHEMISTRY
|
Official in PF
|
32(3)
|
USP 30 1S
|
GC
|
|
<731> LOSS ON DRYING
|
Official
|
pre-1998
|
pre-USP 23
|
GC
|
|
<733> LOSS ON IGNITION
|
Official
|
pre-1998
|
pre-USP 23
|
GC
|
|
<736> MASS SPECTROMETRY
|
Official
|
pre-1998
|
pre-USP 23
|
GC
|
|
<741> MELTING RANGE OR TEMPERATURE
|
Official
|
27(1)
|
USP 24
|
GC
|
|
<751> METAL PARTICLES IN OPHTHALMIC OINTMENTS
|
Official
|
pre-1998
|
pre-USP 23
|
EGC
|
|
<755> MINIMUM FILL
|
Official
|
pre-1998
|
USP 23
|
PS
|
|
<761> NUCLEAR MAGNETIC RESONANCE
|
Official
|
pre-1998
|
pre-USP 23
|
GC
|
|
<771> OPHTHALMIC OINTMENTS
|
Official
|
pre-1998
|
pre-USP 23
|
EGC
|
|
<776> OPTICAL MICROSCOPY
|
Official
|
30(6)
|
USP 28 2S
|
GC
|
|
<781> OPTICAL ROTATION
|
Official
|
27(4)
|
USP 25 1S
|
GC
|
|
<785> OSMOLALITY AND OSMOLARITY
|
Official in PF
|
32(3)
|
USP 30 1S
|
GC
|
|
<786> PARTICLE SIZE DISTRIBUTION ESTIMATION BY ANALYTICAL SIEVING
|
Official
|
30(6)
|
USP 28 2S
|
EGC
|
|
<788> PARTICULATE MATTER IN INJECTIONS
|
Official
|
28(6)
|
USP 26 2S
|
PPI
|
|
<789> PARTICULATE MATTER IN OPHTHALMIC SOLUTIONS
|
Official
|
28(5)
|
USP 27 1S
|
PPI
|
|
<791> pH
|
Official
|
29(6)
|
pre-USP 23
|
GC
|
|
<795> PHARMACEUTICAL COMPOUNDING--NONSTERILE PREPARATIONS
|
Official
|
29(1)
|
USP 27 1S
|
CRX
|
|
<797> PHARMACEUTICAL COMPOUNDING--STERILE PREPARATIONS
|
Official in PF
|
32(3)
|
USP 30 1S
|
SCC
|
|
<801> POLAROGRAPHY
|
Official
|
pre-1998
|
pre-USP 23
|
GC
|
|
<811> POWDER FINENESS
|
Official in PF
|
28(2)
|
USP 23
|
EGC
|
|
<821> RADIOACTIVITY
|
Official
|
pre-1998
|
USP 23
|
RMI
|
|
<823> RADIOPHARMACEUTICALS FOR POSITRON EMISSION TOMOGRAPHY--COMPOUNDING
|
Official
|
29(2)
|
USP 23
|
RMI
|
|
<831> REFRACTIVE INDEX
|
Official
|
pre-1998
|
pre-USP 23
|
GC
|
|
<841> SPECIFIC GRAVITY
|
Official
|
31(2)
|
USP 29
|
GC
|
|
<846> SPECIFIC SURFACE AREA
|
Official
|
30(4)
|
USP 28 1S
|
GC
|
|
<851> SPECTROPHOTOMETRY AND LIGHT-SCATTERING
|
Official
|
33(5)
|
USP 30 2S
|
GC
|
|
<861> SUTURES--DIAMETER
|
Official
|
pre-1998
|
pre-USP 23
|
GTMDB
|
|
<871> SUTURES--NEEDLE ATTACHMENT
|
Official
|
25(6)
|
USP 24
|
GTMDB
|
|
<881> TENSILE STRENGTH
|
Official
|
25(6)
|
USP 24
|
GTMDB
|
|
<891> THERMAL ANALYSIS
|
Official
|
pre-1998
|
USP 23
|
GC
|
|
<905> UNIFORMITY OF DOSAGE UNITS
|
Official in PF
|
32(4)
|
USP 30
|
PDF
|
|
<907> UNIT OF USE PACKAGES AND PRESRIPTIONS--TESTA AND ASSAYS FOR TABLETS AND CAPSULES
|
New in Development
|
n/a
|
USP 31
|
PS
|
|
<909> UNIFORMITY OF LIQUIDS, INJECTIONS, AND TOPICALS
|
New in Development
|
n/a
|
USP 33
|
PDF
|
|
<911> VISCOSITY
|
Official
|
pre-1998
|
pre-USP 23
|
EGC
|
|
<912> NON-NEWTONIAN RHEOLOGY
|
New in Development
|
n/a
|
USP 32
|
EGC
|
|
<913> VISCOELASTICITY
|
New in Development
|
n/a
|
USP 32
|
EGC
|
|
<921> WATER DETERMINATION
|
Official in PF
|
31(2)
|
USP 27 2S
|
GC
|
|
<941> X-RAY DIFFRACTION
|
Official in PF
|
32(4)
|
USP 30 2S
|
GC
|
|
<943> X-RAY DIFFRACTION -- SOLIDS
|
New in PF
|
28(3)
|
USP 32
|
GC
|
|
<1005> ACOUSTIC EMISION
|
New in Development
|
32(4)
|
USP 30 2S
|
GC
|
|
<1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT
|
Official
|
30(1)
|
USP 28
|
STAT
|
|
<1015> AUTOMATED RADIOCHEMICAL SYNTHESIS APPARATUS
|
Official
|
pre-1998
|
pre-USP 23
|
RMI
|
|
<1021> BARRIER TECHNOLOGIES
|
New in Development
|
n/a
|
USP 33
|
MSA
|
|
<1031> THE BIOCOMPATIBILITY OF MATERIALS USED IN DRUG CONTAINERS, MEDICAL DEVICES, AND IMPLANTS
|
Official
|
25(3)
|
USP 24
|
GTMDB
|
|
<1032> DESIGN AND DEVELOPMENT OF BIOASSAYS
|
New in Development
|
n/a
|
USP 31
|
BBPP
|
|
<1033> VALIDATION OF BIOLOGICAL ASSAYS
|
New in Development
|
n/a
|
USP 32
|
STAT
|
|
<1035> BIOLOGICAL INDICATORS FOR STERILIZATION
|
Official
|
27(4)
|
USP 24
|
MSA
|
|
<1036> BIOLOGICAL INDICATORS FOR CHEMICAL STERILIZATION
|
New in Development
|
n/a
|
USP 33
|
MSA
|
|
<1038> Chemical Imaging
|
New in Development
|
n/a
|
|
|
|
<1039> Chemometrics: Multivariate Analysis
|
New in Development
|
n/a
|
|
|
|
<1040> GOOD DISPENSING PRACTICES
|
New in Development
|
n/a
|
USP 32
|
CRX
|
|
<1041> BIOLOGICS
|
Official
|
pre-1998
|
USP 23
|
BBPP
|
|
<1043> ANCILLARY MATERIALS FOR CELL, GENE AND TISSUE ENGINEERED PRODUCTS
|
Official
|
n/a
|
USP 28 1S
|
BBCGT
|
|
<1045> BIOTECHNOLOGY-DERIVED ARTICLES
|
Official
|
pre-1998
|
USP 23
|
BBPP
|
|
<1046> CELL AND GENE THERAPY PRODUCTS
|
Official
|
27(1)
|
USP 25 1S
|
BBCGT
|
|
<1047> BIOTECHNOLOGY-DERIVED ARTICLES--TESTS
|
Official in PF
|
32(2)
|
USP 30 1S
|
BBPP
|
|
<1048> QUALITY OF BIOTECHNOLOGICAL PRODUCTS: ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF r-DNA DERIVED PROTEIN PRODUCTS
|
Official
|
pre-1998
|
USP 23
|
BBPP
|
|
<1049> QUALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY TESTING OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS
|
Official
|
pre-1998
|
USP 23
|
BBPP
|
|
<1050> VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN
|
Official
|
pre-1998
|
USP 32
|
BBPP
|
|
<1051> CLEANING GLASS APPARATUS
|
Official
|
30(1)
|
USP 26 2S
|
GC
|
|
<1052> BIOTECHNOLOGY-DERIVED ARTICLES -- AMINO ACID ANALYSIS
|
New in PF
|
32(2)
|
USP 30 1S
|
BBPP
|
|
<1053> BIOTECHNOLOGY-DERIVED ARTICLES -- CAPILLARY ELECTROPHORESIS
|
New in PF
|
32(2)
|
USP 30 1S
|
BBPP
|
|
<1054> BIOTECHNOLOGY-DERIVED ARTICLES -- ISOELECTRIC FOCUSING
|
New in PF
|
32(2)
|
USP 30 1S
|
BBPP
|
|
<1055> BIOTECHNOLOGY-DERIVED ARTICLES -- PEPTIDE MAPPING
|
New in PF
|
32(2)
|
USP 30 1S
|
BBPP
|
|
<1056> BIOTECHNOLOGY-DERIVED ARTICLES -- POLYACRYLAMIDE GEL ELECTROPHORESIS
|
New in PF
|
32(2)
|
USP 30 1S
|
BBPP
|
|
<1057> BIOTECHNOLOGY-DERIVED ARTICLES -- TOTAL PROTEIN ASSAY
|
New in PF
|
32(2)
|
USP 30 1S
|
BBPP
|
|
<1058> ANALYTICAL INSTRUMENT QUALIFICATION
|
New in PF
|
32(6)
|
USP 30 2S
|
GC
|
|
EXCIPIENT PERFORMANCE
|
New in Development
|
33(1)
|
USP 31
|
EGC
|
|
<1061> COLOR—INSTRUMENTAL MEASUREMENT
|
Official
|
pre-1998
|
USP 23
|
GC
|
|
<1065> ION CHROMATOGRAPHY
|
Official in PF
|
32(3)
|
USP 30 1S
|
GC
|
|
<1069> GOOD STERILE COMPOUNDING PRACTICES
|
New in Development
|
n/a
|
USP 33
|
SCC
|
|
<1070> EMERGENCY MEDICAL SERVICES VEHICLES AND AMBULANCES--STORAGE OF PREPARATIONS
|
New in PF
|
32(3)
|
USP 30 1S
|
PS
|
|
<1072> DISINFECTANTS AND ANTISEPTICS
|
New in PF
|
30(6)
|
USP 29 2S
|
MSA
|
|
<1073> EFFUSIVITY
|
New in PF
|
30(4)
|
USP 32
|
GC
|
|
<1074> EXCIPIENT BIOLOGICAL SAFETY EVALUATION GUIDELINES
|
Official
|
24(3)
|
USP 24
|
GTMDB
|
|
<1075> GOOD COMPOUNDING PRACTICES
|
Official
|
31(1)
|
USP 32
|
CRX
|
|
<1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS
|
Official in PF
|
28(5)
|
USP 24
|
EGC
|
|
<1079> GOOD STORAGE AND SHIPPING PRACTICES
|
Official
|
32(4)
|
USP 30 2S
|
PS
|
|
<1080> BULK PHARMACEUTICAL EXCIPIENTS--CERTIFICATE OF ANALYSIS
|
New in PF
|
31(4)
|
USP 31
|
EGC
|
|
<1081> GEL STRENGTH OF GELATIN
|
Official
|
pre-1998
|
pre-USP 23
|
EGC
|
|
<1082> GENOTOXICITY TESTING
|
New in PF
|
30(1)
|
USP 32
|
GTMDB
|
|
<1083> HAZARDOUS DRUG PRODUCTS - LABELING AND PACKAGING
|
New in PF
|
pre-1998
|
USP 33
|
NOM
|
|
<1084> GLYCOPROTEIN AND GLYCAN ANALYSIS
|
New in Development
|
n/a
|
USP 31
|
BBPP
|
|
<1085> GLYCOPROTEIN AND GLYCAN ANALYSIS -- DEGLYCOSYLATION OF GLYCOPROTEINS
|
New in Development
|
n/a
|
USP 31
|
BBPP
|
|
<1086> IMPURITIES IN OFFICIAL ARTICLES
|
Official
|
32(5)
|
USP 30 2S
|
GC
|
|
<1087> INTRINSIC DISSOLUTION
|
Official in PF
|
32(5)
|
USP 31 2S
|
BPC
|
|
<1088> IN VITRO AND IN VIVO EVALUATION OF DOSAGE FORMS
|
Official
|
pre-1998
|
USP 23
|
BPC
|
|
<1089> IN VITRO ABSORPTION -- INDICATING CELL CULTURE SYSTEM
|
New in PF
|
25(5)
|
USP 32
|
GTMDB
|
<1090> IN VIVO BIOEQUIVALENCE GUIDANCES
(DRUG PRODUCT INTERCHANGEABILITY)
|
Official in PF
|
32(6)
|
USP 32
|
BPC
|
|
<1091> LABELING OF INACTIVE INGREDIENTS
|
Official
|
pre-1998
|
pre-USP 23
|
NOM
|
|
<1092> THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION
|
New in PF
|
31(5)
|
USP 29 2S
|
BPC
|
|
<1093> STORAGE AND DISTRIBUTION OF TEMPERATURE SENSITIVE OR COLD CHAIN PHARMACEUTICALS
|
New in Development
|
32(6)
|
USP 31
|
PS
|
|
<1094> GLYCOPROTEIN AND GLYCAN ANALYSIS -- MONOSACCHARIDE ANALYSIS
|
New in Development
|
n/a
|
USP 31
|
BBPP
|
|
<1095> GLYCOPROTEIN AND GLYCAN ANALYSIS -- OLIGOSACCHARIDE ANALYSIS
|
New in Development
|
n/a
|
USP 31
|
BBPP
|
|
<1096> NATURAL RUBBER LATEX AND ITS PRODUCTS -- MEASUREMENT OF ANTIGENIC PROTEIN
|
New in PF
|
pre-1998
|
USP 32
|
GTMDB
|
|
<1101> MEDICINE DROPPER
|
Official
|
30(6)
|
USP 28 2S
|
PDF
|
|
<1106> MICROBIAL INTEGRITY TESTING OF CONTAINERS AND CLOSURES
|
New in Development
|
n/a
|
USP 33
|
MSA
|
|
<1111> MICROBIOLOGICAL ATTRIBUTES OF NONSTERILE PHARMACEUTICAL PRODUCTS
|
Official in PF
|
29(5)
|
USP 29 2S
|
MSA
|
|
<1112> MICROBIOLOGICAL ATTRIBUTES OF NONSTERILE PHARMACEUTICAL PRODUCTS -- APPLICATION OF WATER ACTIVITY DETERMINATION
|
New in PF
|
30(5)
|
USP 29 2S
|
MSA
|
|
<1116> MICROBIOLOGICAL EVALUATION OF CLEAN ROOMS AND OTHER CONTROLLED ENVIRONMENTS
|
Official in PF
|
31(2)
|
USP 23
|
MSA
|
|
<1117> MICROBIOLOGICAL GOOD LABORATORY PRACTICES
|
New in PF
|
30(5)
|
USP 29 2S
|
MSA
|
|
<1118> MONITORING DEVICES--TIME, TEMPERATURE, AND HUMIDITY
|
Official in PF
|
32(3)
|
USP 30
|
PS
|
|
<1119> NEAR-INFRARED SPECTROPHOTOMETRY
|
Official
|
32(6)
|
USP 31
|
GC
|
|
<1120> RAMAN SPECTROPHOTOMETRY
|
Official
|
32(4)
|
USP 30 2S
|
GC
|
|
<1121> NOMENCLATURE
|
Official
|
32(4)
|
USP 30 2S
|
NOM
|
|
<1125> NUCLEIC ACID-BASED METHODS
|
New in Development
|
n/a
|
USP 31
|
BBVV
|
|
<1136> PACKAGING -- UNIT OF USE
|
Official
|
30(5)
|
USP 28 2S
|
PS
|
|
<1141> PACKAGING, STORAGE AND DISTRIBUTION OF PHARMACOPEIAL ARTICLES
|
New in PF
|
26(2)
|
pre-USP 23
|
PS
|
|
<1146> PACKAGING PRACTICE--REPACKAGING A SINGLE SOLID ORAL DRUG PRODUCT INTO A UNIT-DOSE CONTANER
|
Official
|
28(2)
|
USP 25 1S
|
PS
|
|
<1150> PHARMACEUTICAL STABILITY
|
Official
|
32(4)
|
USP 30 2S
|
PS
|
|
<1151> PHARMACEUTICAL DOSAGE FORMS
|
Official
|
29(5)
|
USP 27 2S
|
PDF
|
|
<1160> PHARMACEUTICAL CALCULATIONS IN PRESCRIPTION COMPOUNDING
|
Official in PF
|
31(3)
|
USP 29 1S
|
CRX
|
|
<1163> QUALITY CONTROL AND ANALYTICAL TESTING IN PHARMACEUTICAL COMPOUNDING
|
New in Development
|
32(5)
|
USP 30 2S
|
PS
|
|
<1165> RADIOPHARMACEUTICALS QUALITY ASSURANCE -- COMPOUNDING
|
New in Development
|
n/a
|
USP 33
|
RMI
|
|
<1171> PHASE-SOLUBILITY ANALYSIS
|
Official
|
pre-1998
|
pre-USP 23
|
GC
|
|
<1172> PHOTOSTABILITY TESTING
|
New in PF
|
26(2)
|
USP 32
|
GC
|
|
<1174> POWDER FLOW
|
Official
|
28(2)
|
USP 28 2S
|
EGC
|
|
<1175> PREFORMULATION GUIDELINES
|
New in PF
|
26(6)
|
to be canceled
|
PS
|
|
<1176> PRESCRIPTION BALANCES AND VOLUMETRIC APPARATUS
|
Official
|
pre-1998
|
pre-USP 23
|
CRX
|
|
<1177> GOOD PACKAGING PRACTICES
|
Official
|
30(6)
|
USP 28 2S
|
PS
|
|
<1178> GOOD REPACKAGING PRACTICES
|
Official
|
32(5)
|
USP 30 2S
|
PS
|
|
<1181> SCANNING ELECTRON MICROSCOPY
|
Official
|
pre-1998
|
pre-USP 23
|
GC
|
|
<1184> SENSITIZATION TESTING
|
New in PF
|
30(1)
|
USP 32
|
GTMDB
|
|
<1186> SHIPPING AND STORAGE OF LABILE PREPARATIONS
|
New in PF
|
28(2)
|
to be canceled
|
PS
|
|
<1191> STABILITY CONSIDERATIONS IN DISPENSING PRACTICE
|
Official
|
28(1)
|
USP 24
|
PS
|
|
<1194> RESIDUAL SOLVENTS-THE TRIPARTITE GUIDELINE
|
New in PF
|
27(6)
|
to be canceled
|
GC
|
|
<1195> SIGNIFICANT CHANGE GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS
|
New in PF
|
31(4)
|
USP 31 1S
|
EGC
|
|
<1196> PHARMACOPEIAL HARMONIZATION
|
Official
|
30(4)
|
USP 26 2S
|
HDQ
|
|
<1198> STANDARDIZED IMPRINT CODES FOR SOLID ORAL DOSAGE FORMS
|
New in PF
|
28(1)
|
to be canceled
|
PDF
|
|
<1207> STERILE PRODUCT PACKAGING--INTEGRITY EVALUATION
|
Official
|
27(5)
|
USP 26
|
MSA
|
|
<1208> STERILITY TESTING--VALIDATION OF ISOLATOR SYSTEMS
|
Official in PF
|
30(6)
|
USP 30 2S
|
MSA
|
|
<1209> STERILIZATION--CHEMICAL AND PHYSICOCHEMICAL INDICATORS AND INTEGRATORS
|
Official
|
29(1)
|
USP 27 1S
|
MSA
|
|
<1211> STERILIZATION AND STERILITY ASSURANCE OF COMPENDIAL ARTICLES
|
Official in PF
|
30(5)
|
USP 32
|
MSA
|
|
<1216> TABLET FRIABILITY
|
Official in PF
|
30(5)
|
USP 30
|
PDF
|
|
<1217> TABLET BREAKING FORCE
|
New in PF
|
31(6)
|
USP 30 2S
|
PDF
|
|
<1221> TEASPOON
|
Official
|
pre-1998
|
pre-USP 23
|
PS
|
|
<1222> TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTS--PARAMETRIC RELEASE
|
Official in PF
|
30(5)
|
USP 30 2S
|
MSA
|
|
<1223> VALIDATION OF ALTERNATIVE MICROBIOLOGICAL METHODS
|
New in PF
|
31(5)
|
USP 29 2S
|
MSA
|
|
<1224> VALIDATION OF ASEPTIC PROCESSES
|
New in Development
|
n/a
|
USP 33
|
MSA
|
|
<1225> VALIDATION OF COMPENDIAL METHODS
|
Official in PF
|
31(2)
|
USP 29 1S
|
GC
|
|
<1226> VERIFICATION OF COMPENDIAL PROCEDURES
|
New in PF
|
32(5)
|
USP 30 2S
|
GC
|
|
<1227> VALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES
|
Official
|
25(1)
|
USP 23
|
MSA
|
|
<1228> PROCESS CHARACTERIZATION AND VALIDATION FOR PROTEIN PRODUCTS
|
New in Development
|
n/a
|
USP 31
|
BBPP
|
|
<1229> VALIDATION OF STERILIZATION PROCESSES
|
New in Development
|
n/a
|
USP 33
|
MSA
|
|
<1230> WATER FOR HEALTH APPLICATIONS
|
Official in PF
|
31(5)
|
USP 28 1S
|
PW
|
|
<1231> WATER FOR PHARMACEUTICAL PURPOSES
|
Official
|
30(5)
|
USP 28 2S
|
PW
|
|
<1232> INSTRUMENTATION FOR ANALYSIS OF HIGH PURITY PHARMACEUTICAL WATERS
|
New in PF
|
30(5)
|
USP 31 1S
|
PW
|
|
<1235> VACCINE TEST METHODS
|
New in Development
|
n/a
|
USP 31
|
BBVV
|
|
<1236> VETERINARY BIOPHARMACEUTICS CLASSIFICATION SYSTEM
|
New in Development
|
33(5)
|
USP 31 2S
|
VET
|
|
<1237> VIROLOGY TEST METHODS
|
New in Development
|
n/a
|
USP 31
|
BBVV
|
|
<1241> WATER-SOLID INTERACTIONS IN PHARMACEUTICAL SYSTEMS
|
Official
|
pre-1998
|
USP 23
|
PW
|
|
<1251> WEIGHING ON AN ANALYTICAL BALANCE
|
Official
|
25(5)
|
USP 24
|
GC
|
|
<1260> MONOCLONAL ANTIBODIES
|
New in Development
|
n/a
|
USP 31
|
BBPP
|
|
<1265> WRITTEN PRESCRIPTION DRUG INFORMATION--GUIDELINES
|
Official
|
30(3)
|
USP 28 2S
|
PS
|
|
<2021> MICROBIAL ENUMERATION TESTS--NUTRITIONAL AND DIETARY SUPPLEMENTS
|
Official
|
29(1)
|
USP 27 1S
|
MSA
|
|
<2022> MICROBIOLOGICAL PROCEDURES FOR ABSENCE OF SPECIFIED MICROORGANISMS--NUTRITIONAL AND DIETARY SUPPLEMENTS
|
Official
|
29(1)
|
USP 27 1S
|
MSA
|
|
<2023> MICROBIOLOGICAL ATTRIBUTES OF NONSTERILE NUTRITIONAL AND DIETARY SUPPLEMENTS
|
Official
|
30(5)
|
USP 29
|
MSA
|
|
<2030> SUPPLEMENTAL INFORMATION FOR ARTICLES OF BOTANICAL ORIGIN
|
Official
|
31(2)
|
USP 29 1S
|
DSB
|
|
<2040> DISINTEGRATION AND DISSOLUTION OF DIETARY SUPPLEMENTS
|
Official in PF
|
32(1)
|
USP 30 1S
|
DSBA
|
|
<2091> WEIGHT VARIATION OF DIETARY SUPPLEMENTS
|
Official
|
28(5)
|
USP 23
|
DSGC
|
|
<2750> MANUFACTURING PRACTICES FOR DIETARY SUPPLEMENTS
|
Official
|
28(2)
|
pre-USP 23
|
DSGC
|
|
<1229D> DRY HEAT STERILIZATION -- PROCESS VALIDATION
|
New in Development
|
n/a
|
USP 33
|
MSA
|
|
<1229E> ETHYLENE OXIDE STERILIZATION -- PROCESS VALIDATION
|
New in Development
|
n/a
|
USP 33
|
MSA
|
|
<1229F> FILTRATION STERILIZATION -- PROCESS VALIDATION
|
New in PF
|
28(6)
|
USP 33
|
MSA
|
|
<1229R> RADIATION STERILIZATION -- PROCESS VALIDATION
|
New in Development
|
n/a
|
USP 33
|
MSA
|
|
<1229S> STEAM STERILIZATION -- PROCESS VALIDATION
|
New in Development
|
n/a
|
USP 33
|
MSA
|
|
Develop a GC on validation and use of test kits (cross-functional activites)
|
New in Development
|
|
|
|
|
Develop a GC on tissue engineering
|
New in Development
|
|
|
|
|
Glycoprotein and Glycan Analysis
|
New in Development
|
|
|
|
|
Somatropin Bioassays
|
New in Development
|
|
|
|
|
Design and Development of Bioassays
|
New in Development
|
|
|
|
|
Monoclonal Antibodies
|
New in Development
|
|
|
|
|
Mass Spectrometry (Proteins, Glycoproteins)
|
New in Development
|
|
|
|
|
Develop Chapter on immunological methods
|
New in Development
|
|
|
|
|
Develop Chapter on nucleic acid amplification techniques
|
New in Development
|
|
|
|
|
Develop GC(s) on VVI and VVI-relevant methods
|
New in Development
|
|
|
|
|
Develop new GCs for Determination of Botanicals in Combination with other Dietary Supplements
|
New in Development
|
|
|
|
|
<xxxx> IMMUNE GLOBULINS -- GENERAL
|
New in Development
|
n/a
|
to be canceled
|
BBBBP
|
|
<xxxx> LIGAND ASSAY TECHNIQUES
|
New in Development
|
n/a
|
to be canceled
|
BBPP
|
|
<xxxx> ASSESSMENT OF BLEND UNIFORMITY
|
New in Development
|
n/a
|
to be canceled
|
GC
|
|
<xxxx> INVERSE GAS CHROMATOGRAPHY
|
New in Development
|
n/a
|
to be canceled
|
GC
|
|
<xxxx> PARTICLE SIZE DISTRIBUTION DESCRIPTION
|
New in Development
|
n/a
|
to be canceled
|
GC
|
|
<xxxx> PHYSICAL FORMS OF PHARMACEUTICAL SOLIDS
|
New in Development
|
n/a
|
to be canceled
|
GC
|
|
<xxxx> PHOTON CORRELATION SPECTROSCOPY
|
New in Development
|
n/a
|
USP 32
|
GC
|
|
<xxxx> ZETA POTENTIAL
|
New in Development
|
n/a
|
USP 32
|
GC
|
|
<73> Placeholder
|
|
|
|
|
|
<xxxx> Mycoplasma
|
New in Development
|
|
|
|
|
<xxxx> Tse
|
New in Development
|
|
|
|
|
<xxxx> Ethylene Oxide Gas Sterilization
|
New in Development
|
|
|
|
|
<xxxx> Dry-Heat Sterilization And Depyrogenation
|
New in Development
|
|
|
|
|
<xxxx> Ionizing Radiation Sterilization
|
New in Development
|
|
|
|
|
<xxxx>
|
New in Development
|
|
|
|
|
<xxxx> Moist Heat Sterilization
|
New in Development
|
|
|
|
|
<xxxx> Filtration Sterilization
|
New in Development
|
|
|
|
|
<xxxx> New overarching statistics Chapter addressing practical aspects of metrology testing
|
New in Development
|
|
|
|
|
<xxxx> New Singlet testing Chapter - hypothesis testing
|
New in Development
|
|
|
|
|
<xxxx> Chemometrics Chapter(s)
|
New in Development
|
|
|
|
* N.B. - Because of the ongoing nature of General Chapter development and revision, the information in this table is subject to change and should be regarded as a close approximation of current status.
