A
An Abbreviated New Drug Application, submitted to the US FDA for approval of a generic medicine. Rather than repeating…
API (Active Pharmaceutical Ingredient)The substance in a medicine that is intended to provide the pharmacological effect, also called the drug substance or b…
AR GradeAnalytical Reagent grade: a high-purity grade of laboratory chemical with a specified minimum assay and maximum limits…
AssayThe measured content of the main component in a material, usually expressed as a percentage by weight on an as-is, drie…
B
A unique code identifying a quantity of material produced in a single manufacturing run or defined process, with unifor…
BP (British Pharmacopoeia)The official collection of standards for medicinal substances and products in the United Kingdom, prepared by the Briti…
BufferA solution that resists changes in pH when small amounts of acid or base are added, usually made from a weak acid and i…
Building BlockA relatively small, functionalised molecule, such as a substituted heterocycle, amino acid derivative, boronic acid or…
C
A unique numerical identifier assigned by the Chemical Abstracts Service, a division of the American Chemical Society,…
CatalystA substance that increases the rate of a chemical reaction without being consumed overall, by providing an alternative…
Certificate of Analysis (COA)A document issued for a specific lot or batch that lists the tests performed, the specification limits and the actual r…
Certificate of Suitability (CEP)A certificate issued by the European Directorate for the Quality of Medicines & HealthCare confirming that a relevant E…
Chelating AgentA molecule that binds a metal ion through two or more donor atoms, forming a stable ring-shaped complex called a chelat…
Chiral PurityThe extent to which a chiral substance consists of a single enantiomer, usually reported as enantiomeric excess (ee) or…
CIF (Cost, Insurance and Freight)An Incoterm for sea transport in which the seller pays freight to the named destination port and arranges minimum marin…
CoagulantA chemical, usually a salt of a trivalent metal such as aluminium sulfate, ferric chloride or polyaluminium chloride, t…
Custom SynthesisThe preparation of a compound to a customer's specification when it is not available commercially, or not at the requir…
D
An Incoterm usable for any mode of transport in which the seller delivers goods, ready for unloading, at a named place…
Deuterated CompoundA compound in which one or more hydrogen atoms are replaced by deuterium, the stable heavy isotope of hydrogen. Deutera…
Drug Master File (DMF)A confidential submission to a regulator, most commonly the US FDA, containing detailed information about the manufactu…
E
One of a pair of stereoisomers that are non-superimposable mirror images of each other, usually due to a stereocentre s…
EP / Ph. Eur. (European Pharmacopoeia)The pharmacopoeia published by the European Directorate for the Quality of Medicines & HealthCare, part of the Council…
ExcipientAny component of a medicine other than the active ingredient, such as fillers, binders, disintegrants, lubricants, pres…
EXW (Ex Works)The Incoterm placing minimum obligation on the seller, who makes the goods available at its premises. The buyer arrange…
F
A compendium of standards for the identity, purity and quality of food ingredients, including additives, processing aid…
Flash PointThe lowest temperature at which a liquid gives off enough vapour to form an ignitable mixture with air near its surface…
FlocculantA substance, typically a high-molecular-weight polymer such as polyacrylamide, that bridges destabilised particles into…
FOB (Free On Board)An Incoterm for sea and inland waterway transport in which the seller clears goods for export and loads them on board t…
G
A separation technique in which a vaporised sample is carried by an inert gas through a heated column, and components s…
Genotoxic ImpurityAn impurity that can damage DNA and potentially cause mutations or cancer, even at very low levels. In pharmaceuticals,…
GHS (Globally Harmonized System)The United Nations Globally Harmonized System of Classification and Labelling of Chemicals, which defines common criter…
GLP (Good Laboratory Practice)A quality system, defined internationally by OECD principles, covering the organisation and conditions under which non-…
GMP (Good Manufacturing Practice)A system of quality requirements ensuring that medicines and their ingredients are consistently produced and controlled…
H
A traditional pharmacopoeial limit test in which metals that form coloured sulfides, such as lead, were measured togeth…
Hill NotationA convention for writing molecular formulae in which carbon is listed first, then hydrogen, then all other elements in…
HPLCHigh-performance liquid chromatography, a technique that separates the components of a solution by pumping it at high p…
HPLC GradeA grade of solvent or reagent tested specifically for high-performance liquid chromatography, with limits on UV absorba…
HSN CodeA product classification code based on the Harmonized System maintained by the World Customs Organization. The first si…
HygroscopicDescribes a substance that readily absorbs moisture from the air. Hygroscopic materials, such as anhydrous calcium chlo…
I
The Dangerous Goods Regulations published annually by the International Air Transport Association, based on the ICAO Te…
ICH M7The ICH guideline on the assessment and control of DNA-reactive (mutagenic) impurities in pharmaceuticals to limit pote…
ICH Q3A and Q3BInternational Council for Harmonisation guidelines on impurities in new drug substances (Q3A) and new drug products (Q3…
IMDG CodeThe International Maritime Dangerous Goods Code, published by the International Maritime Organization, which governs th…
InChIKeyA fixed-length, 27-character hashed version of the IUPAC International Chemical Identifier (InChI), designed for search…
IncotermsStandard trade terms published by the International Chamber of Commerce that define which party pays for transport, ins…
IntermediateA material produced during the synthesis of an API that undergoes further chemical transformation before becoming the A…
IP (Indian Pharmacopoeia)The official book of standards for drugs in India, published by the Indian Pharmacopoeia Commission under the Ministry…
ISO 17034An international standard specifying general requirements for the competence of reference material producers, covering…
IUPAC NameA systematic chemical name constructed according to the nomenclature rules of the International Union of Pure and Appli…
L
The time between order confirmation, or receipt of payment, and dispatch of goods. It depends on stock availability, so…
Letter of Credit (LC)A payment undertaking issued by a bank on behalf of a buyer, committing to pay the seller when specified documents, suc…
LOD and LOQThe limit of detection (LOD) is the lowest amount of an analyte that a method can reliably detect. The limit of quantit…
Loss on Drying (LOD)The percentage loss in mass of a sample when dried under specified conditions, such as a stated temperature, time or va…
LR GradeLaboratory Reagent grade: chemicals of good purity, typically 97 to 99%, suitable for general laboratory work, synthesi…
M
The concentration of a solution expressed as moles of solute per litre of solution, written mol/L or M. To prepare a so…
Molecular WeightThe sum of the atomic weights of all atoms in a molecule, expressed in g/mol and more precisely called molar mass. It i…
MOQ (Minimum Order Quantity)The smallest quantity a supplier will sell in a single order or batch. In chemicals, MOQs typically reflect pack sizes,…
N
P
A transport classification indicating the degree of danger of many dangerous goods: Packing Group I for high danger, II…
pHA measure of the acidity or basicity of an aqueous solution, defined as the negative base-10 logarithm of hydrogen ion…
PharmacopoeiaAn official compendium of quality standards for medicines and their ingredients, containing monographs that specify ide…
PolymorphOne of two or more crystalline forms of the same compound, differing in how molecules are packed in the crystal lattice…
Proforma Invoice (PI)A preliminary invoice issued before shipment that sets out the goods, quantities, prices, delivery terms, payment terms…
PyrophoricDescribes a substance that ignites spontaneously on contact with air, typically within minutes, without an external ign…
R
The European Union Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (EC 1907/2006…
Reference StandardA highly characterised material of established identity and purity used as a benchmark in analytical testing, for examp…
Residue on Ignition (Sulfated Ash)A test measuring the non-volatile inorganic residue left after a sample is ignited with sulfuric acid, which converts m…
Retest DateThe date after which a material should be re-examined to confirm it still meets specification before use. It is common…
S
A standardised document describing a chemical's hazards and how to handle, store, transport and dispose of it safely. U…
Scale-UpThe process of transferring a chemical reaction from laboratory scale to larger quantities, such as from grams to kilog…
Secondary StandardA working reference standard whose identity and assay have been established by comparison with a primary standard, such…
SMILESThe Simplified Molecular Input Line Entry System, a text notation that describes a chemical structure as a string of ch…
SurfactantA surface-active agent whose molecules have a water-loving head and a water-repelling tail, allowing it to lower surfac…
T
U
A four-digit number assigned by the UN Committee of Experts on the Transport of Dangerous Goods to identify a dangerous…
USP (United States Pharmacopeia)The United States Pharmacopeia–National Formulary, published by the United States Pharmacopeial Convention, which sets…
UV CutoffThe wavelength below which a solvent absorbs ultraviolet light too strongly to be used, conventionally where its absorb…