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AC Anticaking agent

Ad Addendum

ADI Accepted Daily Intake

AF Antifoaming (or defoaming) agent

ANDA Abridged New Drug Application

AOX Antioxidant

API Active Pharmaceutical Ingredient

Art Artificial

Avg Average

B&N Buffer and neutralizing agent

BAN British Approved Name

BCS Biopharmaceutical Classification System

BL Bleaching agent or flour-maturing agent

BP British Pharmacopoeia

BRP Biological Reference Preparation

BSE Bovine Spongiform Encephalopathy

bw Body Weight

CAS No. Chemical Abstracts Service Number

CEP Certficate of Suitability to the monograph of the European Pharmacopoeia

Cfu Colony Forming Unit

CHMP The Committee for Medicinal Products for Human Use

ChP Chinese Pharmacopoeia (also CP)

CLP Classification, Labeling and Packaging (under Regulation (EC) No 1272/2008)

CMC Critical Micelle Concentration

CoA Certificate of Analysis

COC Certificate of Conformance

CofA Certificate of Analysis

cP Centipoise

CRS Chemical Reference Substance

CT Clinical Trial

CTD Common Technical Document

CTG Component or coating for fruits & vegetables

D&C Dyes & Cosmetics (designation applied in the USA)

DAB Germany Pharmacopoeia (Deutsches Arzneibuch)

DAC Germany Pharmaceutical Codex

DMF Drug Master File

DMPK Drug Metabolism and Pharmacokinetics

DS Degree of Substitution

DS Dietary supplement

EC Number European Community Number

EINECS European INventory of Existing Commercial chemical Substances

EMA European Medicines Agency

EMUL Emulsifier

ENZ Enzyme

EP European Pharmacopoeia

ESO Essential oil and/or oleoresin (solvent free)

FAO Food and Agricultural Organisation

FCC Food Chemicals Codex

FDA Food and Drug Administration

FEED Substances under the Food Additives Amendment added directly to feed

FL/ADJ Substance used in conjunction with flavours

FLAV Natural flavoring agent

FUM Fumigant

FUNG Fungicide

GCP Good Clinical Practice

GDP Good Distribution Practice

GHS Globally Harmonized System (of Classification and Labelling of Chemicals)

GMO Genetically Modified Organism

GMP Good Manufacturing Practice

GRAS Generally Regarded As Safe

HERB Herbicide

HFC Hydrofluorocarbon

HLB Hydrophilic-Lipophilic Balance

HOR Hormone

ICH International Conference on Harmonization

IIG Inactive Ingredients (Database)

IM Intramuscular

INCHI International Chemical Identifier

INCI International Nomenclature of Cosmetic Ingredients

Incl Including

INH Inhibitor

INN International Non-proprietary Name

INN International Non-proprietary Name

IP Indian Pharmacopoeia

IP Intraperitoneal

ISO International Organisation for Standardization

IU International Unit

IV Intraveneous

JP Japanese Pharmacopoeia

JPE Japanese Pharmaceutical Excipients

LAL Limulus Amoebocyte Lysate

LD Lethal dose

LOA Letter of Access (to a DMF)

LOD Loss in Drying

MAA Marketing Authorization Applicatin

MAA Marketing Authorization Application

MAH Marketing Authorization Holder

Mfr Manufacturer

mg Milligram

MIC Minimum Inhibitory Concentration

MISC Miscellaneous

ml Millilitre

Mn Molecular Number

Mr Relative Molecular Mass

MSDS Material Safety Data Sheet

MW Molecular Weight

NAT Natural substances and extractives

NCE New Chemical Entitity

NDA New Drug Application

NDA New Drug Application

NF National Formulary

NIR Near Infrared

nm Nanometer

NMT Not More Than

NNS Non-nutritive sweetener

nonStdzd Non-standardized

NUTR Nutrient

NUTRS Nutritive Sweetener

PEST Pesticide other than fumigant

pH Negative logarithm of the hydrogen ion concentration

Ph.Eur European Pharmacopoeia

PMCPA Prescirption Medicines Code of Practice Authority

PRES Chemical preservative

PSUR Periodic Safety Update Report

QA Quality Assurance

QbD Quality by Design

QC Quality Control

QP Qualified Person

R Reagent (Substance or solution defined as a reagent)

R&D Research and Development

RDA Recommended Daily Allowance (USA)

REACH Registration, Evaluation, Authorisation and Restriction of Chemicals

Res Residue

SANI Sanitizing agent for food processing equipment

SDA Solubilizing and dispersing agent

SDS Safety Data Sheet

SEM Scanning Electron Micrograph

SEQ Sequestrant

SOLV Solvent

SP Spices, other natural seasonings & flavorings

SP/ADJ Spray adjuvant

Spec Specifications

SPF Specified-Pathogen Free

STAB Stabilizer

Suppl Supplement

SY/FL Synthetic flavor

tab Tablet

TDLO Lowest Toxic Dose

TPN Total Parenteral Nutrition

TSE Transmissible Spongiform Encephalopathy

TWA Time Weighted Average

UNII Unique Ingredient Identifier

USAN United States Adopted Name

UV Ultraviolet

v/v Volume in Volume

VET Veterinary drug, which may leave residue in edible tissues of animals or in edible animal products

W/O Water in Oil

W/O/W Water-in-oil-in Water

w/w Weight in Weight

WHO World Health Organisation

Xref Cross-reference

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