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
- <51> Antimicrobial Effectiveness Testing
- <55> Biological Indicators – Resistance Performance Tests
- <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
- <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
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
- <85> Bacterial Endotoxins Test
- <87> Biological Reactivity Tests, In Vitro
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
- <211> Arsenic
- <221> Chloride and Sulfate
- <223> Dimethylaniline
- <226> 4-Epianhydrotetracycline
- <228> Ethylene Oxide and Dioxane
- <231> Heavy Metals
- <232> Elemental Impurities – Limits
<233> Elemental Impurities – Procedures - <241> Iron
- <251> Lead
- <261> Mercury (Method I only)
- <271> Readily Carbonizable Substances Test
- <281> Residue on Ignition
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
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