USP General Chapters

USP General Chapters


ACTA’s chemistry analysts are extensively trained and routinely perform the following USP chemical tests and assays.

Microbiological Tests

Total Coliforms per FDA BAM

Screening for other objectionable microorganisms not included in the USP, such as Pseudomonas cepacia and Klebsiella.

Biological Tests and Assays

Identification Tests

  • <181> Identification – Organic Nitrogenous Bases
  • <191> Identification Tests – General
  • <193> Identification – Tetracyclines (Method II only)
  • <197> Spectrophotometric Identification Tests
  • <201> Thin-Layer Chromatographic Identification Test

Limit Tests

Other Tests and Assays

  • <301> Acid-Neutralizing Capacity
  • <341> Antimicrobial Agents – Content
  • <345> Assay for Citric Acid/Citrate and Phosphate
  • <351> Assay for Steroids
  • <381> Elastomeric Closures for Injections
  • <391> Epinephrine Assay
  • <401> Fats and Fixed Oils
  • <411> Folic Acid Assay
  • <413> Impurities Testing in Medical Gases
    <415> Medical Gases Assay
  • <425> Iodometric Assay – Antibiotics
  • <441> Niacin or Niacinamide Assay
  • <451> Nitrite Titration
  • <461> Nitrogen Determination
  • <466> Ordinary Impurities
  • <467> Residual Solvents
  • <481> Riboflavin Assay
  • <501>Salts of Organic Nitrogenous Bases
  • <503> Acetic Acid in Peptides
  • <511> Single-Steroid Assay
  • <525> Sulfur Dioxide
  • <531> Thiamine Assay
  • <541> Titrimetry
  • <551> Vitamin E Assay
  • <561> Articles of Botanical Origin
  • <571> Vitamin A Assay
  • <581> Vitamin D Assay
  • <591> Zinc Determination

Physical Tests and Determinations

  • <603> Topical Aerosols
    <604> Leak Rate
  • <611> Alcohol Determination
  • <621> Chromatography
  • <631> Color and Achromicity
  • <641> Completeness of Solution
  • <643> Total Organic Carbon
  • <645> Water Conductivity
  • <651> Congealing Temperature
  • <661> Plastic Packaging Systems and their Materials of Construction
    • <661.1> Plastic Materials of Construction
    • <661.2> Plastic Packaging Systems for Pharmaceutical Use
  • <671> Containers – Performance Testing
  • <698> Deliverable Volume
  • <701> Disintegration
  • <711> Dissolution
  • <721> Distilling Range
  • <724> Drug Release
  • <730> Plasma Spectrochemistry
  • <731> Loss on Drying
  • <733> Loss on Ignition
  • <736> Mass Spectrometry
  • <741> Melting Range or Temperature
  • <755> Minimum Fill
  • <771> Ophthalmic Products – Quality Tests
  • <781> Optical Rotation
  • <785> Osmolality and Osmolarity
  • <787> Subvisible Particulate Matter in Therapeutic Protein Injections
  • <788> Particulate Matter in Injections
  • <789> Particulate Matter in Ophthalmic Solutions
  • <791> pH
  • <831> Refractive Index
  • <841> Specific Gravity
  • <853> Fluorescence Spectroscopy
  • <854> Mid-Infrared Spectroscopy
  • <857> Ultraviolet-Visible Spectroscopy
  • <891> Thermal Analysis
  • <905> Uniformity of Dosage Units
  • <911> Viscosity – Capillary Viscometer Methods
  • <912> Viscosity – Rotational Methods
  • <921> Water Determination

General Information

  • <1052> Biotechnology – Derived Articles – Amino Acid Analysis
    <1057> Biotechnology – Derived Articles – Total Protein Assay
  • <1065> Ion Chromatography
  • <1072> Disinfectants and Antiseptics
  • <1086> Impurities in Drug Substances and Drug Products
  • <1092> The Dissolution Procedure: Development and Validation
  • <1111> Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use
  • <1116> Microbiological Control and Monitoring of Aseptic Processing Environments
  • <1117> Microbiological Best Laboratory Practices
  • <1151> Pharmaceutical Dosage Forms
  • <1223> Validation of Alternative Microbiological Methods
  • <1224>Transfer of Analytical Procedures
  • <1225> Validation of Compendial Procedures
  • <1226> Verification of Compendial Procedures
  • <1227> Validation of Microbial Recovery from Pharmacopeial Articles
  • <1230> Water for Hemodialysis Applications
  • <1231> Water for Pharmaceutical Purposes
  • <1788> Methods for the Determination of Particulate Matter in Injections and Ophthalmic Solutions

Dietary Supplements

  • <2021> Microbial Enumeration Tests – Nutritional and Dietary Supplements
  • <2022> Microbiological Procedures for Absence of Specified Microorganisms – Nutritional and Dietary Supplements
  • <2023> Microbiological Attributes of Nonsterile Nutritional and Dietary Supplements
  • <2030> Supplemental Information for Articles of Botanical Origin
  • <2040> Disintegration and Dissolution of Dietary Supplements
  • <2091> Weight Variation of Dietary Supplements