Draft for consultation: Quality of natural health products guide: Acronyms, glossary, references

On this page

• Appendix 1 – Acronyms and abbreviations
• Appendix 2 – Glossary
• Appendix 3 – References

Appendix 1 – Acronyms and abbreviations

AIA:

acid insoluble ash

ANI:

average nucleotide identity

AOAC:

Association of Official Analytical Collaboration International (previously, the Association of Official Analytical Chemists)

AOAC OMA:

Official methods of analysis of the Association of Official Analytical Chemists

API:

analytical profile index

AST:

antimicrobial susceptibility testing

ATCC:

American Type Culture Collection

AV:

anisidine value

aw:

water activity

B.P. (or BP):

The British Pharmacopoeia

b.w.:

body weight

BCC:

Burkholderia cepacia complex

C.F.:

The Canadian Formulary

CAM:

US FDA Foods Program compendium of analytical laboratory methods : Chemical Analytical Manual

CARD:

Comprehensive Antibiotic Resistance Database

CAS:

Chemical Abstracts Service

CBD:

cannabidiol

CFU:

colony forming units

CLSI:

Clinical and Laboratory Standards Institute

CU:

content uniformity

dDDH:

digital DNA–DNA hybridization

DEG:

diethylene glycol

DNA:

deoxyribonucleic acid

EFSA:

European Food Safety Authority

EMA:

European Medicines Agency

ERIC-PCR:

enterobacterial repetitive intergenic consensus polymerase chain reaction

EU:

European Union

FAO:

Food and Agriculture Organization of the United Nations

FCC:

Food Chemicals Codex

FPS:

finished product specifications

GACP:

Good Agricultural and Collection Practices

GMP:

good manufacturing practices

HAB:

Homöopathisches ArzneiBuch (German Homeopathic Pharmacopoeia)

HPLC:

high-performance thin-layer chromatography

HPLC-MS:

high-performance liquid chromatography-mass spectrometry analysis

HPLC-UV:

high-performance liquid chromatography-ultraviolet

HPUS:

Homeopathic Pharmacopeia of the United States

IAEA:

International Atomic Energy Agency

ICH:

International Council for Harmonisation

IPC:

in-process control

IR:

infrared

ISO:

International Organization for Standardization

JECFA:

Joint FAO/WHO Expert Committee on Food Additives

LBP:

live biotherapeutic products

LOD:

loss on drying

mEq:

milliequivalent

MIC:

minimum inhibitory concentration

mL:

millilitre

MRL:

maximum residue limit

mSv:

millisievert

N.F.:

The National Formulary

NCBI:

National Center for Biotechnology Information

NCTC:

National Collection of Type Cultures

NGS:

next-generation sequencing

NHP:

natural health product

NHPID:

Natural Health Products Ingredients Database

NHP MAP:

Natural health products management of applications policy

NHP-MF:

natural health product master file

NIH:

National Institutes of Health (United States)

NLT:

not less than

NMT:

not more than

NNHPD:

Natural and Non-prescription Health Products Directorate

OJEU:

Official Journal of the European Union

OOS:

out-of-specification

PCBs:

polychlorinated biphenyls

PCDDs:

polychlorinated dibenzo-para-dioxins

PCDFs:

polychlorinated dibenzofurans

PCR:

polymerase chain reaction

PDE:

permitted daily exposure

PFGE:

pulse-field gel electrophoresis

pg:

picogram

Ph.Eur.:

European Pharmacopoeia

Ph.F.:

Pharmacopée française

Ph.I.:

Pharmacopoeia Internationalis

PIC/S:

Pharmaceutical Inspection Co-operation Scheme

PL:

product licence

ppb:

parts per billion

ppm:

parts per million

PRD:

Pesticides Regulatory Directorate

PV:

peroxide value

QAP:

quality assurance person

RAPD-PCR:

random amplification of polymorphic DNA-polymerase chain reaction

rep-PCR:

repetitive element sequence-based polymerase chain reaction

SL:

site licence

SRM:

specified risk material

TAMC:

total aerobic microbial count

TEF:

toxic equivalent factor

TEQ:

toxic equivalent

THC:

delta-9-tetrahydrocannabinol

TOTOX:

total oxidation value

TSE:

transmissible spongiform encephalopathy

TYMC:

total combined yeasts and moulds count

U.S.P. (or USP):

The United States Pharmacopeia

US EPA:

United States Environmental Protection Agency

US FDA:

United States Food and Drug Administration

WHO:

World Health Organization

WV:

weight variation

% v/v:

percent volume/volume

% w/v:

percent weight/volume

% w/w:

percent weight/weight

Appendix 2 – Glossary

Acceptance criteria (or tolerance limits): Numerical limits, ranges or other suitable measures for acceptance of the results of analytical procedures. (adapted from ICH guideline Q7)

Alga (algae, in the plural form): A member of one of the protist biological kingdoms. It consists of unicellular, colonial or relatively simple multicellular eukaryotes, and it has a cell wall containing cellulose or silica. Algae usually produce their own food by photosynthesis and are mostly aquatic. Examples of algae are Auxenochlorella pyrenoidosa (formerly named Chlorella pyrenoidosa) and Laminaria digitata.

Amino acid: A class of organic molecule that contains amino and carboxyl groups. Amino acids form the main constituents of proteins that are found in a plant or a plant material, an alga, a fungus, a bacterium or a non-human animal material. The following are amino acids:

• L-alanine
• L-arginine
• L-asparagine
• L-aspartic acid
• L-cysteine
• L-glutamine
• L-glutamic acid
• L-glycine
• L-histidine
• L-isoleucine
• L-leucine
• L-lysine
• L-methionine
• L-phenylalanine
• L-proline
• L-serine
• L-threonine
• L-tryptophan
• L-tyrosine
• L-valine

Approved cultivar: Any variety of industrial hemp set out in the List of Approved Cultivars, published by the Government of Canada on its website, as amended from time to time.

Assay: An analytical procedure for determining the quantity or potency and purity of an ingredient.

Bacterium (bacteria, in the plural form): A member of one of the biological kingdoms of the domains Bacteria or Archaea. It consists of usually unicellular (sometimes aggregated, colonial or simple multicellular) prokaryotes whose cells lack nuclei or other internal compartmentalization but have a cell wall external to the plasma membrane in most species.

Batch: A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. For continuous production, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval. (adapted from ICH guideline Q7)

Batch-to-batch consistency: The application of product knowledge, good agricultural or wildcrafting practices, and GMP to minimize inherent variations in the composition of natural substances in order to ensure a consistent product from one batch to the next.

Botanical ingredient (botanical): Any plant, macroscopic fungus or alga. (adapted from US FDA)

CAS registry number: Used for substance identification. It is a unique and unambiguous identifier that is easily validated and internationally recognized for a specific substance avoiding confusion from multiple or similar names. (adapted from CAS Registry)

Chemical name: The unambiguous name of a chemical substance cited in the International Union of Pure and Applied Chemistry Nomenclature or other scientific literature.

Compliance: The state of conformity of a regulated party (including a corporation, institution, individual or other legal entity) or a product with a legislative or regulatory requirement, or a recognized standard.

Crude material: A botanical or animal material that is unprocessed. It may be fresh or dried and either whole or reduced in particle size by cutting or grinding.

Degradation product: A molecule resulting from a chemical change in the active medicinal ingredient brought about over time and/or by the action of light, temperature, pH, water, or by reaction with an excipient and/or the immediate container/closure system. Contact with air/oxygen or another oxidative process can also form a degradation product. Also called decomposition product. (adapted from ICH guideline Q6A)

Dosage form: The final physical form of the NHP which may be used by the consumer without requiring any further manufacturing.

Enzyme: Proteins that act as catalysts in all living organisms – microorganisms, plants, animals, and humans. Catalysts are compounds that increase the rate of chemical reactions in biological systems.

Essential fatty acid: An essential fatty acid cannot be synthesized in the body; hence, it must be supplied through diet or supplement. Linoleic acid and alpha-linolenic acid are essential fatty acids. All other fatty acids (such as oleic acid, gamma-linoleic acid, arachidonic acid, eicosapentaenoic acid and docosahexaenoic acid) are considered extracts or isolates.

Extended release: Products which are formulated to make the medicinal ingredient(s) available over an extended period after administration. (adapted from ICH guideline Q6A) Expressions such as "prolonged release", "repeat action", "controlled release", "long acting", and "sustained release" also have been used to describe such dosage forms.

Extract: A substance prepared by treating a plant or plant material, an alga, a bacterium, a fungus or a non-human animal material using extraction techniques such as cold pressing, solvents to obtain the desired compounds.

Finished product: A product that has undergone all stages of production, including packaging into its final container and labelling.

Fungus (fungi, in the plural form): A member of the biological kingdom Fungi. A fungus consists mainly of complex multicellular eukaryotes that have a cell wall composed primarily of chitin. Fungi are heterotrophs that absorb nutrients from their surroundings by decomposing organic materials.

In-process tests: Tests which may be performed during the manufacture of the NHP, rather than as part of the finished product tests which are conducted prior to release. (adapted from ICH guideline Q6A)

Isolate: A purified constituent of a defined molecular structure obtained from a plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material.

Marker: A constituent that occurs naturally in the material and that is selected for special attention (for example, for identification or standardization purposes) by a researcher or manufacturer. Markers are not necessarily pharmacologically active.

• Active constituent marker: A known and generally accepted constituent or group(s) of constituents that contributes to therapeutic activity. The product can be adjusted (for example, by being diluted) by standardization to a level of active constituent marker that is reproducible – either to a level that is naturally found in the plant or to a more concentrated level in an extract.
• Analytical marker: A constituent or group(s) of constituents that serves solely for the purpose of batch-to-batch consistency and does not contribute to therapeutic activity, to which the product is adjusted to achieve batch-to-batch consistency.

Master cell bank: Defined as a collection of cells of uniform composition derived from a single source (for example, a single cell or a single colony) that is prepared under defined culture conditions, aliquoted into multiple containers, and stored typically cryopreserved under defined conditions. The master cell bank serves as the primary source for the generation of working cell banks and is extensively characterized to ensure its identity, purity, viability, genetic stability, and freedom from adventitious agents (for example, bacteria, fungi, mycoplasma or viruses).

Mineral: A naturally occurring solid, inorganic substance with a definite and predictable chemical composition and physical properties.

Moiety (moieties, in the plural form): A part or functional group of a molecule or substance.

Natural health product: A substance set out in Schedule 1 of the Natural Health Products Regulations or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in:

• the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans
• restoring or correcting organic functions in humans or
• modifying organic functions in humans

However, an NHP does not include a substance set out in Schedule 2 of the Natural Health Products Regulations or any combination of substances that includes a substance set out in Schedule 2.

Non-human animal material: A member of the biological kingdom Animalia. An animal consists of complex multicellular eukaryotes whose cells have a membrane but no wall. Most members have muscles and nervous tissues. They are heterotrophs that mostly ingest food into a specialized cavity, where it is digested. A non-human animal material is a body part or secretion obtained from an animal other than a human and used in the preparation of an NHP. Examples are elk antler velvet, bovine colostrum, and shark cartilage.

Overage: Overage is the percentage of a medicinal ingredient in excess of the labelled claim to compensate for loss of the ingredient during manufacturing.

Plant: A member of the biological kingdom Plantae and is either the whole plant or parts thereof.

Plant material: A material obtained from a plant, including pollens, nucleic materials, mitochondria, chlorophyll and exudates such as resin.

Potency: The amount of the standardized component(s) per dosage unit which further characterizes the quantity of the medicinal ingredient. It is necessary when a claim on the potency is required on the label, or it is required for a specific product (for example, when literature supports the product with that standardized component).

Primary reference standard: A primary reference standard is a highly characterized substance or material used as the definitive benchmark to calibrate analytical instruments, validate test methods, verify the quality of substances, or used for standardization of secondary standards or working standards. It is typically prepared and certified by a recognized pharmacopoeia (for example, USP, Ph.Eur.) or obtained from another recognized authority such as the WHO's International Chemical Reference Substances. In absence of a standard from a recognized authority, it can be prepared from highly purified existing production material and serves as the highest level of accuracy and traceability in a quality management system.

Probiotic: Live microorganisms which when administered in adequate amounts confer a health benefit on the host.

Product licence holder: An individual with legal ownership of and responsibility for the NHP. The PL holder may be located in or outside of Canada. PL holders who are located outside of Canada must identify a Canadian representative.

Purity: The extent to which a raw material or a product in dosage form is free from undesirable or adulterating chemical, biological or physical entities as defined by specification.

Qualification: The process of acquiring and evaluating data that establishes the biological safety of an individual degradation product or a given degradation profile at the level(s) specified. (adapted from ICH guideline Q3A)

Quantity: The amount of medicinal ingredient(s) per dosage unit.

Raw material: Any substance, other than in-process product or packaging material, intended to be used in the manufacture of products. Includes those that appear in the master formula but that do not appear in the product such as solvents and processing aids.

Sale: See "Sell".

Scientific rationale: A justification that is in accordance with the principles and methods of science. This justification must be supported by reference(s) and/or data to explain the underlying issues that lead to the need to prepare such a rationale.

Sell: Includes offer for sale, expose for sale, have in possession for sale – or distribute to one or more persons, whether or not the distribution is made for consideration, and lease, offer for lease, expose for lease or have possession for lease. For clarity, the word "consideration" can take various forms, including:

• monetary payment
• promise to do something
• promise to refrain from doing something

Shelf life: The time period during which a finished product is expected to remain within the approved shelf-life specifications, provided that it is stored under the conditions defined on the container label. (adapted from ICH guideline Q1A)

Specifications: Quality standards which include tests, references to test methods and appropriate acceptance criteria (tolerance limits), which are numerical limits, ranges or other criteria for the tests described. Specifications establish the criteria to which a finished product should conform to be considered fit for its intended use. (adapted from ICH guideline Q6A)

Synthetic duplicate: A substance that shares an identical chemical structure and pharmacological properties with its natural counterpart.

Vitamin: One of a group of naturally occurring organic substances required in small amounts by the body to maintain health. The following are vitamins: Biotin, Folate, Niacin, Pantothenic acid, Riboflavin, Thiamine, Vitamin A, Vitamin B6, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, Vitamin K1, and Vitamin K2.

Working cell bank: Defined as a homogeneous pool of micro-organisms or cells that are derived by propagation of cells from the master cell bank under defined conditions, expanded by serial subculture which are stored in controlled conditions to ensure stability and for use in production.

Appendix 3 – References

Laws and regulations

• Cannabis Act
• Cannabis Regulations
• Controlled Drugs and Substances Act
• Food and Drug Regulations
• Food and Drugs Act
• Industrial Hemp Regulations
• Natural Health Products Regulations
• Pest Control Products Act

Guidelines and other documents

Health Canada

• Adulteration of natural health products
• Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs (GUI-0119)
• Clinical trials for natural health products
• Compendium of analytical methods
• Compendium of monographs
• Cosmetic ingredient hotlist
• Evidence for homeopathic medicines
• Finished product specifications form
• Finished product specifications form user guide
• Good manufacturing practices for infant formula
• Good manufacturing practices guide for natural health products (GUI-0158)
• Guidelines for Canadian drinking water quality: Radiological parameters
• Health products containing cannabis or for use with cannabis: Guidance for the Cannabis Act, the Food and Drugs Act, and related regulations
• List of approved cultivars
• List of banned veterinary drugs
• List of certification bodies under the Canada Organic Regime
• Lists of acceptable polymers for use in food packaging applications
• Master file procedures
• MRLs, human health, and food safety: How MRLs are set
• Natural health products ingredients database
• Natural health products management of applications policy
• Official method: Determination of the disintegration time of tablets (DO-25)
• Pathway for licensing natural health products making modern health claims
• Prescription drug list
• Site licensing guidance document

Association of Official Analytical Collaboration International (AOAC)

• Official methods of analysis

Food Chemicals Codex (FCC)

• Food Chemicals Codex
• Appendix XV: Microbial food cultures including probiotics

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

• ICH guideline M7: Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
• ICH guideline Q1A: Stability testing of new drug substances and products
• ICH guideline Q2: Analytical validation
• ICH guideline Q3A: Impurities in new drug substances
• ICH guideline Q3C: Residual solvents
• ICH guideline Q3D: Elemental impurities
• ICH guideline Q4B: Annex 14: Bacterial endotoxins test general chapter
• ICH guideline Q6A: Specifications: Test procedures and acceptance criteria for new drug substances and new drug products: Chemical substances
• ICH guideline Q7: Good manufacturing practice guide for active pharmaceutical ingredients

Pharmaceutical Inspection Co-operation Scheme (PIC/S)

• Pharmaceutical Inspection Co-operation Scheme
• Annex 1 Manufacture of sterile medicinal products of the Guide to good manufacturing practice for medicinal products

International (various)

• IAEA Radiation protection and safety of radiation sources: International basic safety standards
• International Probiotics Association
• International Union of Pure and Applied Chemistry Nomenclature
• ISO 13559 (IDF 153) Butter, fermented milks and fresh cheese: Enumeration of contaminating microorganisms: Colony-count technique at 30 degrees C
• ISO 6886 Animal and vegetable fats and oils – Determination of oxidative stability (accelerated oxidation test)
• NSF/ANSI 173-2010: Dietary supplements, NSF International Standard/American National Standard
• Organisation for Economic Co-operation and Development (OECD) Series on principles of good laboratory practice and compliance monitoring. Number 1. OECD Principles on good laboratory practice (as revised in 1997). ENV/MC/CHEM(98)17

Canada

• Canadian drinking water guidelines
• Good practices for plant identification for the herbal industry, Saskatchewan Herb and Spice Association/National Herb and Spice Coalition/Agriculture and Agri-Food Canada (2004)

European Union

• EFSA Risk assessment of aflatoxins in food
• EMA Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products
• EMA Guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin
• EMA Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products
• EMA Guideline on the assessment of genotoxicity of herbal substances/preparations
• EMA Guideline on the quality of water for pharmaceutical use
• EMA Reflection paper on markers used for quantitative and qualitative analysis of herbal medicinal products and traditional herbal medicinal products
• European Pharmacopoeia (Ph.Eur.)
  • Ph.Eur. General chapter 2.6.1. Sterility
  • Ph.Eur. General chapter 2.6.7. Mycoplasmas
  • Ph.Eur. General chapter 2.6.12. Microbiological examination of non-sterile products (total viable aerobic count)
  • Ph.Eur. General chapter 2.6.13. Microbiological examination of non-sterile products (test for specified micro-organisms)
  • Ph.Eur. General chapter 2.6.36. Microbiological examination of live biotherapeutic products: Tests for enumeration of microbial contaminants
  • Ph.Eur. General chapter 2.6.38. Microbiological examination of live biotherapeutic products: Tests for specified microorganism
  • Ph.Eur. General chapter 2.8.13. Pesticide residues
  • Ph.Eur. General chapter 2.8.18. Determination of aflatoxin B1 in herbal drugs
  • Ph.Eur. General chapter 2.8.22 Determination of ochratoxin A in herbal drugs
  • Ph.Eur. General chapter 2.9.3. Dissolution test for solid dosage forms
  • Ph.Eur. General chapter 2.9.25. Dissolution test for medicated chewing gums
  • Ph.Eur. General chapter 2.9.40. Uniformity of dosage units
  • Ph.Eur. General chapter 5.1.3. Efficacy of antimicrobial preservation
  • Ph.Eur. General chapter 5.1.4. Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use
  • Ph.Eur. General chapter 5.1.8. Microbiological quality of herbal medicinal products for oral use and extracts used in their preparation
  • Ph.Eur. General chapter 5.2.8 Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products
• European Pharmacopoeia 11th edition - European Directorate for the Quality of Medicines and HealthCare, 2022. Live Biotherapeutic Products for Human Use; p.935-936.
• Guidance document on pesticide analytical methods for risk assessment and post-approval control and monitoring purposes
• OJEU Commission implementing regulation (EU) 2020/1158 on the conditions governing imports of food and feed originating in third countries following the accident at the Chernobyl nuclear power station
• OJEU Commission implementing regulation (EU) 2021/808 on the performance of analytical methods for residues of pharmacologically active substances used in food-producing animals and on the interpretation of results as well as on the methods to be used for sampling and repealing
• OJEU Commission regulation (EC) No 1881/2006 on setting maximum levels for certain contaminants in foodstuffs
• OJEU Commission regulation (EC) No 199/2006 amending Regulation (EC) No 466/2001 on setting maximum levels for certain contaminants in foodstuffs as regards dioxins and dioxin-like PCBs
• OJEU Commission regulation (EU) No 1259/2011 on maximum levels for dioxins, dioxin-like PCBs and non dioxin-like PCBs in foodstuffs
• OJEU Council regulation (EC) No 2375/2001 amending Commission regulation (EC) No 466/2001 setting maximum levels for certain contaminants in foodstuffs
• OJEU Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products

United Kingdom

• British Pharmacopoeia (B.P.)

United Nations

• FAO General specifications and considerations for enzyme preparations
• FAO/WHO Codex Alimentarius - Codex committee on methods of analysis and sampling
• FAO/WHO Codex Alimentarius - Pesticide index
• FAO/WHO Codex Alimentarius - Recommended methods of sampling for the determination of pesticide residues for compliance with MRLs
• FAO/WHO Codex Alimentarius – Standard for fish oils
• FAO/WHO Pesticide residues in food 2021
• General specifications and considerations for enzymes used in food processing, FAO JECFA Monographs 3, Compendium of Food Additive Specifications (2006)
• WHO Call to action to protect children from contaminated medicines
• WHO Critically important antimicrobials for human medicine: 6th revision
• WHO Guide to local production: WHO-recommended handrub formulations
• WHO Guidelines for drinking-water quality
• WHO Guidelines on good agricultural and collection practices for medicinal plants
• WHO List of critically important antimicrobials
• WHO Quality control methods for medicinal plant materials
• WHO Ranking of antimicrobials according to their importance in human medicine: A critical step for developing risk management strategies to control antimicrobial resistance from food animal production

United States

• American Herbal Pharmacopoeia
• American Herbal Products Association: Good agriculture and collection practices
• Best practices guide: Enzyme dietary supplement products
• Dietary reference intakes: The essential guide to nutrient requirements, Institute of Medicine (2006)
• NIH Approved lists of bacterial names
• Standardization of botanical products: White Paper, Botanical Extracts Committee of the American Herbal Products Association (2003)
• US EPA Method 1668B Chlorinated biphenyl congeners in water, soil, sediment, biosolids, and tissue by HRGC/HRMS
• US FDA Blue-green algae products and microcystins
• US FDA Foods program compendium of analytical laboratory methods: Chemical analytical manual (CAM)
• US FDA Guidance for industry: Testing of glycerin, propylene glycol, maltitol solution, hydrogenated starch hydrolysate, sorbitol solution, and other high-risk drug components for diethylene glycol and ethylene glycol
• US FDA Pesticide analytical manual volume I
• United States Pharmacopeia (USP)
  • USP General chapter <5> Inhalation and nasal drug products: General information and product quality tests
  • USP General chapter <51> Antimicrobial effectiveness testing
  • USP General chapter <60> Microbiological examination of nonsterile products: Tests for Burkholderia cepacia complex
  • USP General chapter <61> Microbiological examination of nonsterile products: Microbial enumeration tests
  • USP General chapter <62> Microbiological examination of nonsterile products: Tests for specified microorganisms
  • USP General chapter <63> Mycoplasma tests
  • USP General chapter <64> Probiotics tests
  • USP General chapter <71> Sterility tests
  • USP General chapter <85> Bacterial endotoxins test
  • USP General chapter <197> Spectroscopic identification tests
  • USP General chapter <202> Identification of fixed oils by thin-layer chromatography
  • USP General chapter <203> High-performance thin-layer chromatography procedure for identification of articles of botanical origin
  • USP General chapter <211> Arsenic
  • USP General chapter <233> Elemental impurities: Procedures
  • USP General chapter <401> Fats and fixed oils
  • USP General chapter <467> Residual solvents
  • USP General chapter <561> Articles of botanical origin
  • USP General chapter <565> Botanical extracts
  • USP General chapter <601> Aerosols, nasal sprays, metered-dose inhalers, and dry powder inhalers: Performance quality tests
  • USP General chapter <621> Chromatography
  • USP General chapter <698> Deliverable volume
  • USP General chapter <701> Disintegration
  • USP General chapter <711> Dissolution
  • USP General chapter <724> Drug release (for transdermal system products)
  • USP General chapter <731> Loss on drying
  • USP General chapter <755> Minimum fill
  • USP General chapter <771> Ophthalmic products: Quality tests
  • USP General chapter <789> Particulate matter in ophthalmic solutions
  • USP General chapter <857> Ultraviolet-visible spectroscopy
  • USP General chapter <858> Raman spectroscopy
  • USP General chapter <905> Uniformity of dosage units
  • USP General chapter <921> Test for water determination
  • USP General chapter <922> Water activity
  • USP General chapter <1004> Mucosal drug products: Performance tests
  • USP General chapter <1059> Excipient performance
  • USP General chapter <1064> Identification of articles of botanical origin by high-performance thin-layer chromatography procedure
  • USP General chapter <1072> Disinfectants and antiseptics
  • USP General chapter <1094> Capsules: Dissolution testing and related quality attributes
  • USP <1111> Microbiological examination of nonsterile products: Acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use
  • USP <1151> Pharmaceutical dosage forms
  • USP <1223> Validation of alternative microbiological methods
  • USP <1224> Transfer of analytical procedures
  • USP <1225> Validation of compendial procedures
  • USP <1226> Verification of compendial procedures
  • USP <1231> Water for pharmaceutical purposes
  • USP <1601> Products for nebulization: Characterization tests
  • USP <1663> Assessment of extractables associated with pharmaceutical packaging/delivery systems
  • USP <1664> Assessment of drug product leachable associated with pharmaceutical packaging/delivery systems
  • USP <1711> Oral dosage forms: Performance tests
  • USP <1724> Semisolid drug products: Performance tests
  • USP <1771> Ophthalmic Products: Performance tests
  • USP <2021> Microbial enumeration tests: Nutritional and dietary supplements
  • USP <2022> Microbiological procedures for absence of specified microorganisms: Nutritional and dietary supplements
  • USP <2023> Microbiological attributes of nonsterile nutritional and dietary supplements
  • USP <2040> Disintegration and dissolution of dietary supplements
  • USP <2091> Weight variation of dietary supplements
  • USP <2232> Elemental contaminants in dietary supplements
  • USP <2251> Screening for undeclared drugs and drug analogues

Additional publications

• Chun J., Oren A., Ventosa A., Christensen H., Arahal D.R., da Costa M.S., Roone A.P., Yi H., Xu X.-W., De Meyer S., Trujillo M.E. 2018. Proposed minimal standards for the use of genome data for the taxonomy of prokaryotes. International Journal of Systematic and Evolutionary Microbiology 68: 461-466. (https://doi.org/10.1099/ijsem.0.002516)
• Merenstein D., Pot B., Leyer G., Ouwehand A.C., Preidis G.A., Elkins C.A., Hill C., Lewis Z.T., Shane A.L., Zmora N., Petrova M.I., Collado M.C., Morelli L., Montoya G.A., Szajewska H., Tancredi D.J., Sanders M.E. 2023. Emerging issues in probiotic safety: 2023 perspectives. Gut Microbes 15(1): 2185034. (https://doi.org/10.1080/19490976.2023.2185034)
• Roe A.L., Boyte M.-E., Elkins C.A., Goldman V.S., Heimbach J., Madden E., Oketch-Rabah H., Sanders M.E., Sirois J., Smith A. 2022. Considerations for determining safety of probiotics: A USP perspective. Regulatory Toxicology and Pharmacology 136:105266. (https://doi.org/10.1016/j.yrtph.2022.105266)
• Sanders M.E., Merenstein D.J., Ouwehand A.C., Reid G., Salminen S., Cabana M.D., Paraskevakos G., Leyer G. 2016. Probiotic use in at-risk populations. Journal of the American Pharmacists Association 56: 680-686. (http://dx.doi.org/10.1016/j.japh.2016.07.001)