|
Chapter Title |
Expert Committee |
Liaison |
Official Status |
| <1> Injections |
PPI |
DGH@usp.org |
Official |
| <2>
Default Conditions for Oral Solid Dosage Forms |
PDF |
AHC@usp.org |
New in
Development |
| <3> Product Quality Tests - Topical and Transdermal
Products |
|
MRM@usp.org |
New
in Development |
| <11> Reference Standards |
RS |
PSL@usp.org |
Official
in PF |
| <16> Automated Methods Of Analysis |
GC |
HP@usp.org |
Official |
| <21> Thermometers |
GC |
AHC@usp.org |
Official |
| <31> Volumetric Apparatus |
GC |
HP@usp.org |
Completed
Official |
| <41> Weight and Balances |
GC |
HP@usp.org |
Official
in PF |
| <51> Antimicrobial Effectiveness Testing |
MSA |
RST@USP.org |
Official |
| <55> Biological Indicators – Resistance Performance Tests |
MSA |
RST@usp.org |
Official |
| <61> Microbiological Examination Of Non–Sterile Products:
Microbial Enumeration Tests (Harmonization) |
MSA |
RST@usp.org |
Official |
| <62> Microbiological Examination of Nonsterile Products;
Tests for Specified Microorganisms (Harmonization) |
MSA |
RST@usp.org |
Official |
| <63> Mycoplasma Testing |
MSA |
RST@usp.org |
New
in PF |
| <71> Sterility Tests |
MSA |
RST@usp.org |
Official |
| <81> Antibiotics-Antimicrobial Assays |
MDANT |
AWW@usp.org |
Official |
| <85> Bacterial Endotoxins Test (Harmonization) |
MSA |
RST@usp.org |
Official |
| <87> Biological Reactivity Tests, In Vitro |
GTMDB |
RST@usp.org |
Official |
| <88> Biological Reactivity Tests, In Vivo |
GTMDB |
RST@usp.org |
Official |
| <90> FETAL BOVINE SERUM FUNCTIONALITY TEST <90> FBS Quality Attributes and
Functionality Tests |
BBCGT |
FA@usp.org |
New
in development |
| <91> Calcium Pantothenate Assay |
DSN |
CSP@usp.org |
Official |
| <92> Cytokines and Growth Factors Used as Ancillary
Materials |
BBCGT |
FA@usp.org |
New
in Development |
| <111> Design and Analysis of Biological Assays |
STAT |
TSM@usp.org |
Revision
in PF |
| <115> Dexpanthenol Assay |
DSN |
CSP@usp.org |
Official |
| <121> Insulin Assays |
BBPP |
TZS@usp.org |
Official |
| <123> Glucagon Bioassays |
BBPP |
TZS@usp.org |
New
in Development |
| <124> Epoetin Bioassays |
BBPP |
TZS@usp.org |
New
in Development |
| <126> Somatropin Bioassays |
BBPP |
TZS@usp.org |
New
in Development |
| <130> Protein A Quality Attributes |
BBPP |
AEY@usp.org |
Official |
| <141> Protein-Biological Adequacy Test |
BBPP |
TZS@usp.org |
Official |
| <151> Pyrogen Test |
MSA |
RST@usp.org |
Official |
| <161> Transfusion And Infusion Assemblies And Similar
Medical Devices |
GTMDB |
RST@usp.org |
Official |
| <162> Diphtheria Antitoxin Potency Test for Human
Immunoglobulins |
BBBP |
AEY@usp.org |
New
in Development |
| <165> Prekallikrein Activator Test for Human Plasma –
Derived Products |
BBBP |
AEY@usp.org |
New
in Development |
| <166> Test for Anticomplementary Activity of Human
Immunoglobulins |
BBBP |
AEY@usp.org |
New
in Development |
| <171> Vitamin B12 Activity Assay |
DSN |
CSP@usp.org |
Official |
| <181> Identification–Organic Nitrogenous Bases |
GC |
AHC@usp.org |
Official |
| <191> Identification test – General |
GC |
AHC@usp.org |
Completed
Official |
| <193> Identification-- Tetracyclines |
MDANT |
AWW@usp.org |
Official |
| <197> Spectrophotometric Identification Tests |
GC |
HP@usp.org |
Official
in PF |
| <201> Thin–layer Chromatographic Identification Test |
GC |
HP@usp.org |
Official |
| <206> Aluminum |
GC |
KXZ@usp.org |
Official |
| <207> Test for 1,6 – Anhydro Derivate of Enoxaparin Sodium |
BBBP |
AEY@usp.org |
New
in Development |
| <208> Anti – Factor Iia and Anti–Factor Xa Assays for Low
Molecular Weight Heparins |
BBBP |
AEY@usp.org |
New
in Development |
| <209> Low Molecular Weight Heparin Molecular Weight
Determinations |
BBBP |
AEY@usp.org |
New
in Development |
| <211> Arsenic |
GC |
KXZ@usp.org |
Official |
| <221> Chloride And Sulfate |
GC |
KXZ@usp.org |
Official |
| <223> Dimethylaniline |
MDANT |
AWW@usp.org |
Official |
| <226> 4–Epianhydrotetracycline |
MDANT |
AWW@usp.org |
Official |
| <228> Ethylene Oxide and Dioxane |
EGC |
HW@usp.org |
New
in PF |
| <231> Heavy Metals (Harmonization) |
GC |
KXZ@usp.org |
official |
| <232>- Limits |
GC |
KXZ@usp.org |
New
in development |
| <233>- Procedures |
GC |
KXZ@usp.org |
New
in development |
| <241> Iron |
GC |
KXZ@usp.org |
Official |
| <251> Lead |
GC |
KXZ@usp.org |
Official |
| <261> Mercury |
GC |
KXZ@usp.org |
Official |
| <264> Nickel |
EGC |
HW@usp.org |
New
in Development |
| <267> Porosimetry by Mercury Intrusion (Harmonization) |
EGC |
KTM@usp.org |
New
in PF |
| <271> Readily Carbonizable Substances Test |
GC |
AHC@usp.org |
Completed
Official |
| <281> Residue On Ignition (Harmonization) |
GC |
HP@usp.org |
Completed
Official |
| <291> Selenium |
GC |
KXZ@usp.org |
Official |
| <301> Acid–Neutralizing Capacity |
GC |
KXZ@usp.org |
Official |
| <311> Alginates Assay |
EGC |
RHL@usp.org |
Official |
| <331> Amphetamine Assay |
MDPP |
RR@usp.org |
Official |
| <341> Antimicrobial Agents- Content |
MDAA |
BD@usp.org |
Official |
| <345> Assay for Citric Acid/Citrate and Phosphate |
GC |
KXZ@usp.org |
Official |
| <351> Assay for Steroids |
MDPS |
DWV@usp.org |
Official |
| <361> Barbiturate Assay |
MDPP |
RR@usp.org |
Official |
| <365> Biotin Assay |
DSN |
CSP@usp.org |
New
in development |
| <367> Carotenoid Analysis |
|
CSP@usp.org |
New
in Development |
| <371> Cobalamin Radiotracer Assay |
RMI |
RR@usp.org |
Official |
| <381> Elastomeric Closures For Injections |
PS |
DGH@usp.org |
Official |
| <391> Epinephrine Assay |
AER |
KXZ@usp.org |
Official |
| <401> FATS AND FIXED OILS |
EGC |
HW@usp.org |
Official |
| <411> FOLIC ACID ASSAY |
DSN |
CSP@usp.org |
Official |
| <413> IMPURITIES TESTING IN MEDICAL GASES |
AER |
KXZ@usp.org |
New
In PF 35(4) |
| <415> Medical Gases Assay |
AER |
KXZ@usp.org |
New
in PF 35(4) |
| <425> IODOMETRIC ASSAY–ANTIBIOTICS |
MDANT |
AWW@usp.org |
Official |
| <429> Light Diffraction Measurement Of Particle Size
(Harmonization) |
GC |
KXZ@usp.org |
Official |
| <431> METHOXY DETERMINATION |
EGC |
HW@usp.org |
Official |
| <441> NIACIN OR NIACINAMIDE ASSAY |
DSN |
CSP@usp.org |
Official |
| <451> Nitrite Titration |
GC |
AHC@usp.org |
Official |
| <461> Nitrogen Determination |
GC |
AHC@usp.org |
Official |
| <466> Ordinary Impurities |
GC |
AHC@usp.org |
Official |
| <467> Residual Solvents |
GC |
HP@usp.org |
Official |
| <471> Oxygen Flask Combustion |
GC |
HP@usp.org |
Official |
| <481> RIBOFLAVIN ASSAY |
DSN |
CSP@usp.org |
Official |
| <501> Salts Of Organic Nitrogenous Bases |
GC |
AHC@usp.org |
Official |
| <503> Acetic Acid in Peptides |
BBPP |
TZS@usp.org |
Official |
| <511> SINGLE–STEROID ASSAY |
MDPS |
DWV@usp.org |
Official |
| <521> SULFONAMIDES |
MDAA |
BD@usp.org |
Official
(Plan to delete this chapter) |
| <525> SULFUR DIOXIDE |
EGC |
HW@usp.org |
Revision
in PF 35(2) |
| <531> THIAMINE ASSAY |
DSN |
CSP@usp.org |
Official |
| <541> Titrimetry |
GC |
HP@usp.org |
Official |
| <551> ALPHA TOCOPHEROL ASSAY |
DSN |
CSP@usp.org |
Official |
| <561> ARTICLES OF BOTANICAL ORIGIN |
DSGC |
YT@usp.org |
Revision
Proposed |
| <563> IDENTIFICATION OF ARTICLES OF BOTANICAL ORIGIN |
DSB |
MHS@usp.org |
Official |
| <565> BOTANICAL EXTRACTS |
DSB |
MHS@usp.org |
Official |
| <571> VITAMIN A ASSAY |
DSN |
CSP@usp.org |
Official |
| <581> VITAMIN D ASSAY |
DSN |
CSP@usp.org |
Official |
| <591> Zinc Determination |
GC |
KXZ@usp.org |
Official |
| <601> Aerosols, Nasal Sprays, Metered-Dose Inhalers and
Dry Powder Inhalers |
AER |
KXZ@usp.org |
Official |
| <611> Alcohol Determination |
GC |
HP@usp.org |
Completed
Official |
| <616> BULK DENSITY AND TAPPED DENSITY (Harmonization) |
EGC |
KTM@usp.org |
Official |
| <621> Chromatography |
GC |
HP@usp.org |
Official
in PF |
| <631> Color and Achromicity |
GC |
AHC@usp.org |
Official |
| <641> Completeness of Solution |
GC |
AHC@usp.org |
Official |
| <643> Total Organic Carbon |
PW |
AHC@usp.org |
Official
in PF |
| <644> Conductivity (Harmonization) |
GC |
AHC@usp.org |
New
in Development |
| <645> Water Conductivity |
PW |
AHC@usp.org |
Official
in PF |
| <651> CONGEALING TEMPERATURE |
EGC |
HW@usp.org |
Official |
| <659> Preservation, Packaging, Storage and Labeling |
PS |
DGH@usp.org |
New
in Development |
| <660> Containers – Glass |
PS |
DGH@usp.org |
Official |
| <661> Containers – Plastic |
PS |
DGH@usp.org |
Official |
| <662> Containers – Metal |
PS |
DGH@usp.org |
New
in Development |
| <670> Containers – Auxiliary Components |
PS |
DGH@usp.org |
New
in PF |
| <671> Containers – Performance Testing |
PS |
DGH@usp.org |
Official |
| <681> Repackaging into Single–Unit Containers and
Unit–Dose Containers for Nonsterile solid and Liquid Dosage Forms |
PS |
DGH@usp.org |
Official |
| <691> Cotton |
GTMDB |
RST@usp.org |
Official |
| <695> Crystallinity |
GC |
KXZ@usp.org |
Official |
| <696> Crystallinity Determination By Solution Calorimetry
(Harmonization) |
GC |
KXZ@usp.org |
Official |
| <698> Deliverable Volume |
PDF |
WEB@usp.org |
Official |
| <699> DENSITY OF SOLIDS (Harmonization) |
EGC |
KTM@usp.org |
Official |
| <701> Disintegration (Harmonization Stage 6) |
BPC |
WEB@usp.org |
Official |
| <711> Dissolution (Harmonization Stage 6) |
BPC |
WEB@usp.org |
Official
in PF |
| <721> Distilling Range |
GC |
AHC@usp.org |
Official |
| <724> Drug Release |
BPC |
WEB@usp.org |
Official |
| <725> PRODUCT PERFORMANCE TESTS - TOPICAL AND TRANSDERMAL
PRODUCTS |
|
|
|
| <726> Electrophoresis |
GC |
KXZ@usp.org |
Official |
| <727> Capillary Electrophoresis |
GC |
KXZ@usp.org |
Official |
| <729> Globule Size Distribution In Lipid Injectable
Emulsions |
PPI |
DGH@usp.org |
Official |
| <730> Plasma Spectrochemistry |
GC |
KXZ@usp.org |
Official |
| <731> Loss on Drying |
GC |
HP@usp.org |
Official |
| <733> Loss on Ignition |
GC |
HP@usp.org |
Official |
| <736> Mass Spectrometry |
GC |
KXZ@usp.org |
Official |
| <741> Melting Range or Temperature |
GC |
AHC@usp.org |
Official
in PF |
| <751> METAL PARTICLES IN OPHTHALMIC OINTMENTS |
PPI |
DGH@usp.org |
Official |
| <755> Minimum Fill |
PS |
DGH@usp.org |
Official |
| <761> Nuclear Magnetic Resonance |
GC |
KXZ@usp.org |
Official |
| <771> OPHTHALMIC OINTMENTS |
PPI |
DGH@usp.org |
Official |
| <776> Optical Microscopy |
GC |
AHC@usp.org |
Official |
| <781> Optical Rotation |
GC |
AHC@usp.org |
Official |
| <785> Osmolality And Osmolarity |
GC |
HP@usp.org |
Official |
| <786> PARTICLE SIZE DISTRIBUTION ESTIMATION BY ANALYTICAL
SIEVING (Harmonization) |
EGC |
KTM@usp.org |
Official |
| <788> Particulate Matter In Injections (Harmonization) |
PPI |
DGH@usp.org |
Official |
| <789> Particulate Matter In Ophthalmic Solutions |
PPI |
DGH@usp.org |
Official |
| <791> pH |
GC |
AHC@usp.org |
Official |
| <795> PHARMACEUTICAL COMPOUNDING–NONSTERILE PREPARATIONS |
CRX |
RXS@usp.org |
Official |
| <797> PHARMACEUTICAL COMPOUNDING–STERILE PREPARATIONS |
SCC |
SCB@usp.org |
Official |
| <801> Polarography |
GC |
AHC@usp.org |
Official |
| <811> POWDER FINENESS (Harmonization) |
EGC |
KTM@usp.org |
Official |
| <821> RADIOACTIVITY |
RMI |
RR@usp.org |
Official |
| <823> RADIOPHARMACEUTICALS FOR POSITRON EMISSION
TOMOGRAPHY–COMPOUNDING |
RMI |
RR@usp.org |
Official |
| <831> Refractive Index |
GC |
AHC@usp.org |
Official |
| <841> Specific Gravity |
GC |
AHC@usp.org |
Official |
| <846> Specific Surface Area (Harmonization) |
GC |
KXZ@usp.org |
Official |
| <851> Spectrophotometry And Light–Scattering |
GC |
HP@usp.org |
Official
in PF |
| <853> Fluorescence Spectroscopy |
GC |
HP@usp.org |
New
in PF |
| <854> Mid-Infrared Spectroscopy |
GC |
HP@usp.org |
New
in PF |
| <857> UV–Visible spectroscopy |
GC |
HP@usp.org |
New
in PF |
| <858> Vibrational Spectroscopic Imaging |
GC |
HP@usp.org |
New
in Development |
| <861> Sutures–Diameter |
GTMDB |
RST@usp.org |
Official |
| <871> Sutures–Needle Attachment |
GTMDB |
RST@usp.org |
Official |
| <881> Tensile Strength |
GTMDB |
RST@usp.org |
Official |
| <891> Thermal Analysis |
GC |
AHC@usp.org |
Official
in PF |
| <905> Uniformity Of Dosage Units (Harmonization) |
PDF |
WEB@usp.org |
Official
in PF |
| <909> Uniformity of Liquids, Injections, And Topicals |
PDF |
WEB@usp.org |
New
in Development |
| <911> Viscosity |
EGC |
HW@usp.org |
Revision
in PF 34(6) |
| <912> NON-NEWTONIAN RHEOLOGY |
EGC |
HW@usp.org |
New
in PF |
| <921> Water Determination |
GC |
AHC@usp.org |
Official
in PF |
| <941> X–Ray Diffraction (Harmonization) |
GC |
HP@usp.org |
Official |
| <943> X–Ray Diffraction – Solids |
GC |
HP@usp.org |
New
in Development |
| <1005> Acoustic Emission |
GC |
HP@usp.org |
Official |
| <1010> Analytical Data – Interpretation And Treatment |
STAT |
HP@usp.org |
Official |
| <1015> AUTOMATED RADIOCHEMICAL SYNTHESIS APPARATUS |
RMI |
RR@usp.org |
Official |
| <1021> Barrier Technologies |
MSA |
RST@usp.org |
New
in Development |
| <1024> Bovine Serum |
BBCGT |
FA@usp.org |
New
in development |
| <1027> Flow Cytometry |
BBCGT |
FA@usp.org |
New
in development |
| <1028>PARTICLE SIZE MEASUREMENT |
EGC |
HW@usp.org |
New
in Development |
| <1031> The Biocompatibility Of Materials Used In Drug
Containers, Medical Devices, And Implants |
GTMDB |
RST@usp.org |
Official |
| <1032> DESIGN AND DEVELOPMENT OF BIOASSAYS |
BBPP |
TSM@usp.org |
New
in Development |
| <1033> Biological Assay Validation |
STAT |
TSM@usp.org |
PF35(2) |
| <1035> Biological Indicators For Sterilization |
MSA |
RST@usp.org |
Official |
| <1036> Biological Indicators For Chemical Sterilization |
MSA |
RST@usp.org |
New
in Development |
| <1038> VIBRATIONAL SPECTROSCOPIC IMAGING |
GC |
|
|
| <1039> Chemometrics: Multivariate Analysis |
GC |
HP@usp.org |
New
in Development |
| <1040> GOOD DISPENSING PRACTICES |
|
|
|
| <1041> BIOLOGICS |
BBPP |
AK@usp.org |
Official |
| <1043> ANCILLARY MATERIALS FOR CELL, GENE AND TISSUE
ENGINEERED PRODUCTS |
BBCGT |
AEY@usp.org |
Official |
| <1045> BIOTECHNOLOGY–DERIVED ARTICLES |
BBPP |
AK@usp.org |
Official |
| <1046> CELL THERAPY
PRODUCTS |
BBCGT |
FA@usp.org |
Official |
| <1047> GENE THERAPY PRODUCTS |
BBCGT |
FA@usp.org |
New
in Development |
| <1048> QUALITY OF BIOTECHNOLOGICAL PRODUCTS: ANALYSIS OF
THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF r–DNA DERIVED
PROTEIN PRODUCTS |
BBPP |
AK@usp.org |
Official |
| <1049> QUALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY
TESTING OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS |
BBPP |
AK@usp.org |
Official |
| <1050> VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS
DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN |
BBVV |
TZS@usp.org |
Official |
| <1051> Cleaning Glass Apparatus |
GC |
AHC@usp.org |
Official |
| <1052> BIOTECHNOLOGY–DERIVED ARTICLES – AMINO ACID
ANALYSIS |
BBPP |
AK@usp.org |
Official |
| <1053> BIOTECHNOLOGY–DERIVED ARTICLES – CAPILLARY
ELECTROPHORESIS |
BBPP |
AK@usp.org |
Official |
| <1054> BIOTECHNOLOGY–DERIVED ARTICLES – ISOELECTRIC
FOCUSING |
BBPP |
AK@usp.org |
Official |
| <1055> BIOTECHNOLOGY–DERIVED ARTICLES – PEPTIDE MAPPING |
BBPP |
AK@usp.org |
Official |
| <1056> BIOTECHNOLOGY–DERIVED ARTICLES – POLYACRYLAMIDE GEL
ELECTROPHORESIS |
BBPP |
AK@usp.org |
Official |
| <1057> BIOTECHNOLOGY–DERIVED ARTICLES – TOTAL PROTEIN
ASSAY |
BBPP |
AK@usp.org |
Official |
| <1058> Analytical Instrument Qualification |
GC |
HP@usp.org |
Official |
| <1059>
EXCIPIENT PERFORMANCE |
EGC |
RHL@usp.org |
New
in PF 35(5) |
| <1061> Color – Instrument Measurement (Harmonization Stage
3 – Regulatory Consultation and Discussion) |
GC |
AHC@usp.org |
Official |
| <1062> COMPACTABILITY TEST |
EGC |
HW@usp.org |
New
in Development |
| <1065> Ion Chromatography |
GC |
HP@usp.org |
Official |
| <1066> Physical Environments that promote safe medication
use |
SMU |
CYB@usp.org |
New
in PF |
| <1070> Emergency Medical Services Vehicles And Ambulances
– Storage Of Preparations |
PS |
DGH@usp.org |
Official |
| <1072> Disinfectants And Antiseptics |
MSA |
RST@usp.org |
Official |
| <1073> Effusivity |
GC |
HP@usp.org |
New
in PF |
| <1074> Excipient Biological Safety Evaluation Guidelines |
GTMDB |
RST@usp.org |
Official |
| <1075> GOOD COMPOUNDING PRACTICES |
CRX |
RXS@usp.org |
Official |
| <1078> GOOD MANUFACTURING PRACTICES FOR BULK
PHARMACEUTICAL EXCIPIENTS |
EGC |
RHL@usp.org |
Official |
| <1079> Good Storage And Shipping Practices |
PS |
DGH@usp.org |
Official |
| <1080>
BULK PHARMACEUTICAL EXCIPIENTS–CERTIFICATE OF ANALYSIS |
EGC |
RHL@usp.org |
Official |
| <1081> GEL STRENGTH OF GELATIN |
EGC |
HW@usp.org |
Official |
| <1082> Genotoxicity Testing |
GTMDB |
RST@usp.org |
New
in Development |
| <1084> GLYCOPROTEIN AND GLYCAN ANALYSIS – Introduction and
Choice of Analysis Strategies |
BBPP |
AK@usp.org |
New
in development |
| <1085> GLYCOPROTEIN AND GLYCAN ANALYSIS – DEGLYCOSYLATION
OF GLYCOPROTEINS |
BBPP |
AK@usp.org |
New
in Development |
| <1086> Impurities in Official Articles |
GC |
AHC@usp.org |
Official
in PF |
| <1087> Apparent Intrinsic Dissolution |
BPC |
WEB@usp.org |
Official |
| <1088> In Vitro and In Vivo Evaluation Of Dosage Forms |
BPC |
WEB@usp.org |
Official |
| <1090> In Vivo Bioequivalence Guidance |
BPC |
WEB@usp.org |
Official
in PF |
| <1091> LABELING OF INACTIVE INGREDIENTS |
NOM |
AW@usp.org |
Official |
| <1092> The Dissolution Procedure. Development And Validation. |
BPC |
WEB@usp.org |
Official |
| <1094> GLYCOPROTEIN AND GLYCAN ANALYSIS – MONOSACCHARIDE
ANALYSIS |
BBPP |
AK@usp.org |
New
in Development |
| <1095> GLYCOPROTEIN AND GLYCAN ANALYSIS – OLIGOSACCHARIDE
ANALYSIS |
BBPP |
AK@usp.org |
New
in Development |
| <1097> Bulk Powder Sampling Procedures |
STAT |
HP@usp.org |
New
in PF |
| <1098> Validation of Research Test kits |
BBCGT |
FA@usp.org |
New
in development |
| <1101> Medicine Dropper |
PS |
WEB@usp.org |
Official |
| <1102> Immunological Test Methods – General Considerations |
BBVV |
AK@usp.org |
New
in Development |
| <1103> Immunological Test Methods – ELISA |
BBVV |
AK@usp.org |
New
in Development |
| <1104> Immunological Test Methods – Western Blotting |
BBVV |
AK@usp.org |
New
in Development |
| <1105> Immunological Test Methods – Surface Plasmon
Resonance |
BBVV |
AK@usp.org |
New
in Development |
| <1111> Microbiological Examination of Non-Sterile
Products; Acceptance Criteria for Pharmaceutical Preparations and Substances
for Pharmaceutical Use (Harmonization) |
MSA |
RST@usp.org |
Official |
| <1112> Microbiological Attributes of Nonsterile
Pharmaceutical Products – Application of Water Activity Determination |
MSA |
RST@usp.org |
Official |
| <1113> Microbial Identification |
MSA |
RST@usp.org |
New
in PF |
| <1116> Microbiological Evaluation of Clean Rooms and Other
Controlled Environments |
MSA |
RST@usp.org |
Official |
| <1117> Microbiological Best Laboratory Practices |
MSA |
RST@usp.org |
Official |
| <1118> Monitoring Devices – Time, Temperature, And
Humidity |
PS |
DGH@usp.org |
Official |
| <1119> Near–Infrared Spectrophotometry |
GC |
HP@usp.org |
Official |
| <1120> Raman Spectrophotometry |
GC |
HP@usp.org |
Official |
| <1121> NOMENCLATURE |
NOM |
AW@usp.org |
Official |
| <1125>
NUCLEIC ACID-BASED TECHNIQUES – GENERAL |
BBVV |
AEY@usp.org |
Official |
| <1126> NUCLEIC ACID-BASED TECHNIQUES – Extraction, DETECTION, AND SEQUENCING |
BBVV |
AEY@usp.org |
Official |
| <1127> NUCLEIC ACID-BASED TECHNIQUES – AMPLIFICATION |
BBVV |
AEY@usp.org |
Official |
| <1128> NUCLEIC ACID-BASED TECHNICQUES - MICROARRAYS |
BBVV |
AEY@usp.org |
New
in Development |
| <1129> NUCLEIC ACID-BASED TECHNIQUES –Genotyping |
BBVV |
AEY@usp.org |
Official |
| <1130> NUCLEIC ACID-BASED TECHNIQUES – APPROACHES FOR
DETECTING TRACE NUCLEIC ACIDS (RESIDUAL DNA TESTING) |
BBVV |
AEY@usp.org |
Official |
| <1136> Packaging – Unit Of Use |
PS |
DGH@usp.org |
Official |
| <1146> Packaging Practice–Repackaging a Single Solid Oral
Drug Product Into a Unit–Dose Container |
PS |
DGH@usp.org |
Official |
| <1150> Pharmaceutical Stability |
PS |
DGH@usp.org |
Official |
| <1151> Pharmaceutical Dosage Forms |
PDF |
WEB@usp.org |
Official
In PF |
| <1160> PHARMACEUTICAL CALCULATIONS IN PRESCRIPTION
COMPOUNDING |
CRX |
RXS@usp.org |
Official |
| <1163> Quality Assurance in Pharmaceutical Compounding |
CRX |
RXS@usp.org |
Official |
| <1165> RADIOPHARMACEUTICALS QUALITY ASSURANCE –
COMPOUNDING |
RMI |
RR@usp.org |
New
in Development |
| <1171> Phase–Solubility Analysis |
GC |
HP@usp.org |
Official |
| <1174> POWDER FLOW (Harmonization) |
EGC |
KTM@usp.org |
Official |
| <1175> Preformulation Guidelines |
PS |
DGH@usp.org |
New
in Development |
| <1176> PRESCRIPTION BALANCES AND VOLUMETRIC APPARATUS |
CRX |
RXS@usp.org |
Official |
| <1177> Good Packaging Practices |
PS |
DGH@usp.org |
Official |
| <1180> Human Plasma |
BBBP |
AEY@usp.org |
New
in Development |
| <1181> Scanning Electron Microscopy |
GC |
KXZ@usp.org |
Official |
| <1184> Sensitization Testing |
GTMDB |
RST@usp.org |
Official |
| <1191> Stability Considerations In Dispensing Practice |
PS |
DGH@usp.org |
Official |
| <1195>
SIGNIFICANT CHANGE GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS |
EGC |
RHL@usp.org |
Official |
| <1196> PHARMACOPEIAL HARMONIZATION |
HDQ |
KTM@usp.org |
Official |
| <1197> GOOD DISTRIBUTION PRACTICES FOR PHARMACEUTICAL
GRADE EXCIPIENTS |
EGC |
RHL@usp.org |
New
in Development |
| <1207> Sterile Product Packaging–Integrity Evaluation |
MSA |
RST@usp.org |
Official |
| <1208> Sterility Testing – Validation of Isolator Systems |
MSA |
RST@usp.org |
Official |
| <1209> Sterilization–Chemical And Physicochemical
Indicators And Integrators |
MSA |
RST@usp.org |
Official |
| <1211> Sterilization and Sterility Assurance of Compendial
Articles |
MSA |
RST@usp.org |
Official |
| <1216> Tablet Friability (Harmonization) |
PDF |
WEB@usp.org |
Official |
| <1217> Tablet Breaking Force |
PDF |
WEB@usp.org |
Official |
| <1221> Teaspoon |
PS |
DGH@usp.org |
Official |
| <1222> Terminally Sterilized Pharmaceutical Products –
Parametric Release |
MSA |
RST@usp.org |
Official |
| <1223> Validation Of Alternative Microbiological Methods |
MSA |
RST@usp.org |
Official |
| <1224> Validation of Aseptic Processes |
MSA |
RST@usp.org |
New
in Development |
| <1225> Validation of Compendial Procedures |
GC |
HP@usp.org |
Official
in PF |
| <1226> Verification of Compendial Procedures |
GC |
HP@usp.org |
Official |
| <1227> Validation of Microbial Recovery from Pharmacopeial
Articles |
MSA |
RST@usp.org |
Official |
| <1228> PROCESS CHARACTERIZATION AND VALIDATION FOR PROTEIN
PRODUCTS |
BBPP |
AK@usp.org |
New
in Development |
| <1229> Sterilization – General Concepts |
MSA |
RST@usp.org |
New
in Development |
| <1230> Water for Health Applications |
PW |
AHC@usp.org |
Official |
| <1231> Water for Pharmaceutical Purposes |
PW |
AHC@usp.org |
Official
in PF |
| <1232> Instrumentation for Analysis of High Purity
Pharmaceutical Waters |
PW |
AHC@usp.org |
New
in Development |
| <1235> VACCINES FOR HUMAN USE |
BBVV |
FA@usp.org |
In
PF |
| <1236> VETERINARY BIOPHARMACEUTICS CLASSIFICATION SYSTEM |
VET |
EG@usp.org |
New
in Development |
| <1237> VIROLOGY TEST METHODS |
BBVV |
FA@usp.org |
Balloted |
| <1238> Vaccines for Human Use – Bacterial Vaccines |
BBVV |
TZS@usp.org |
New
in Development |
| <1239> Vaccines for Human Use – Viral Vaccines |
BBVV |
TZS@usp.org |
New
in Development |
| <1240> Viral Testing for Blood and Blood Products |
BBVV |
AEY@usp.org |
New
in Development |
| <1241> Water–Solid Interactions In Pharmaceutical Systems
(Harmonization) |
GC |
AHC@usp.org |
Official
in PF |
| <1251> Weighing on an Analytical Balance |
GC |
HP@usp.org |
Official
in PF |
| <1260> MONOCLONAL ANTIBODIES |
BBPP |
AEY@usp.org |
New
in Development |
| <1265> Written Prescription Drug Information – Guidelines |
PS |
DGH@usp.org |
Official |
| <1788> Particulate Matter Determination in Parenteral and
Ophthalmic Products |
PPI |
DGH@usp.org |
New
in development |
| <2021>MICROBIAL ENUMERATION TESTS–NUTRITIONAL AND DIETARY
SUPPLEMENTS |
MSA |
RST@usp.org |
Official |
| <2022>MICROBIOLOGICAL PROCEDURES FOR ABSENCE OF SPECIFIED
MICROORGANISMS–NUTRITIONAL AND DIETARY SUPPLEMENTS |
MSA |
RST@usp.org |
Official |
| <2023>MICROBIOLOGICAL ATTRIBUTES OF NONSTERILE NUTRITIONAL
AND DIETARY SUPPLEMENTS |
MSA |
RST@usp.org |
Official |
| <2030> SUPPLEMENTAL INFORMATION FOR ARTICLES OF BOTANICAL
ORIGIN |
DSGC/DSI |
YT@usp.org /
DNS@usp.org |
Official |
| <2040> DISINTEGRATION AND DISSOLUTION OF DIETARY
SUPPLEMENTS |
DSPS |
ND@usp.org |
Official
in PF |
| <2091> WEIGHT VARIATION OF DIETARY SUPPLEMENTS |
DSGC |
YT@usp.org |
Official |
| <2750> MANUFACTURING PRACTICES FOR DIETARY SUPPLEMENTS |
DSGC |
YT@usp.org |
Revision
Proposed |
| <1229D> Dry Heat Sterilization |
MSA |
RST@usp.org |
New
in Development |
| <1229E>
Ethylene Oxide Sterilization |
MSA |
RST@usp.org |
New
in Development |
| <1229F> Filtration Sterilization |
MSA |
RST@usp.org |
New
in Development |
| <1229R>
Radiation Sterilization |
MSA |
RST@usp.org |
New
in Development |
| <1229S> Steam
Sterilization |
MSA |
RST@usp.org |
New
in Development |
| <2xxx> Irradiation Assays |
DSGC |
YT@usp.org |
New
in Development |
| <2xxx> Supplements Adulteration with Drugs |
DSGC |
YT@usp.org |
New
in Development |
