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Pharma chemical glossary

The words behind every order

Plain-English definitions of the grades, documents, chemistry, formulation terms and trade jargon that purchase, QA and R&D teams meet when buying pharmaceutical raw materials.

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95terms defined
6subject areas
21letters covered
Chemistry

Acid chloride

Acyl chloride

A reactive compound formed from a carboxylic acid, widely used to build amides and esters in API synthesis.

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Chemistry

Acylation

A reaction that adds an acyl group to a molecule, used to make amides and esters. Chloroacetyl chloride is a common acylating agent.

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Chemistry

API

Active Pharmaceutical Ingredient

The biologically active component of a medicine – for example, paracetamol in a paracetamol tablet. Everything else in the dose is an excipient.

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Grades & standards

AR grade

Analytical Reagent grade

A high-purity laboratory grade suitable for analytical work, with tight limits on impurities. Usually supplied in small packs rather than bulk.

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Grades & standards

Assay

The measured content of the main substance in a sample, usually expressed as a percentage (for example, 'assay ≥ 99.0%'). One of the key results on a COA.

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Documents

Batch number

Lot number

The unique code identifying a production batch. It links the material in the drum to its COA, retest date and manufacturing records.

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Trade & logistics

Bill of entry

BoE

The customs declaration filed by the importer (through a customs broker) to clear imported goods and pay duty in India.

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Trade & logistics

Bill of lading

B/L

The carrier's receipt and title document for sea cargo. The holder of the original B/L can take delivery of the goods.

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Formulation

Binder

An excipient that holds powder particles together into granules or tablets. Povidone K30 is a widely used binder in wet granulation.

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Grades & standards

Bloom strength

A measure of gel strength for gelatin, expressed in 'Bloom' (typically 150–280). Higher Bloom gives a firmer gel, chosen to suit hard capsules, softgels or gummies.

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Grades & standards

BP

British Pharmacopoeia

The UK's legally binding collection of pharmaceutical standards. Often requested alongside IP by Indian exporters supplying the UK and Commonwealth markets.

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Trade & logistics

CAD

Cash against documents

A payment method where shipping documents are released to the buyer through the banks only after payment. Less costly than an LC, with less protection.

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Chemistry

CAS number

Chemical Abstracts Service Registry Number

A unique numeric identifier for a chemical substance, written like 123-30-8. Quoting the CAS number removes confusion between trade names and synonyms.

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Regulatory & safety

CDSCO

Central Drugs Standard Control Organisation

India's national regulator for pharmaceuticals and medical devices, under the Ministry of Health and Family Welfare.

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Documents

CEP

Certificate of Suitability

Issued by the EDQM to confirm that a substance's quality is adequately controlled by the Ph. Eur. monograph. Simplifies European regulatory filings.

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Documents

Certificate of origin

A document certifying the country where goods were produced. Required for customs and for duty benefits under trade agreements.

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Trade & logistics

CFR

Cost and Freight

The seller pays sea freight to the destination port, but risk passes to the buyer once the goods are loaded – so the buyer usually insures.

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Chemistry

Chlorinating agent

A reagent that introduces chlorine into a molecule – for example, thionyl chloride converting a carboxylic acid into an acid chloride.

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Trade & logistics

CIF

Cost, Insurance and Freight

As CFR, with the seller also arranging minimum cargo insurance to the destination port. A very common term for chemical imports into India.

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Documents

COA

Certificate of Analysis

A batch-specific document showing test results against the specification – assay, identity, impurities and other parameters – issued by the manufacturer for each lot supplied.

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Trade & logistics

Customs broker

CHA

A licensed agent who files customs documents and clears goods at the port on the importer's behalf.

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Regulatory & safety

CWC Schedule

Chemical Weapons Convention

Lists of chemicals controlled under the Chemical Weapons Convention. Thionyl chloride is a Schedule 3 chemical, so an end-use declaration may be requested.

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Regulatory & safety

Dangerous goods

DG

Substances that pose a risk during transport and must be packed, labelled and documented under specific rules, grouped into classes such as Class 8 (corrosives).

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Regulatory & safety

DGFT

Directorate General of Foreign Trade

The Indian government body that administers foreign trade policy and issues Importer Exporter Codes.

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Formulation

Diluent

Filler

An excipient that adds bulk so a tablet or capsule reaches a practical size. Microcrystalline cellulose, lactose and mannitol are common diluents.

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Formulation

Direct compression

DC

Making tablets by blending powders and compressing them directly, without granulation. Needs free-flowing, compressible excipients such as MCC PH 102.

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Formulation

Disintegrant

An excipient that makes a tablet break apart in the body. 'Superdisintegrants' such as croscarmellose sodium work at low levels of about 0.5–5%.

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Documents

DMF

Drug Master File

A confidential dossier filed with a regulator (such as the US FDA) by a manufacturer, describing how an API or excipient is made and controlled. Buyers reference it in their own filings.

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Formulation

DPI carrier

Dry powder inhaler carrier

Coarse lactose particles that carry fine drug particles in a dry powder inhaler and help them disperse when the patient inhales.

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Trade & logistics

Drum

A cylindrical container – fibre, HDPE or steel, typically 25–250 kg – used for powders, liquids and dangerous goods.

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Trade & logistics

E-way bill

An electronic document required under GST for moving goods above a set value by road within India.

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Grades & standards

Elemental impurities

ICH Q3D

Trace metals such as lead, arsenic, cadmium and mercury. The ICH Q3D guideline sets permitted daily exposures, and buyers often ask for a supplier statement.

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Regulatory & safety

End-use declaration

A statement from the buyer describing how a controlled chemical will be used, sometimes required for sale or export.

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Formulation

Excipient

Any ingredient in a medicine other than the active ingredient – fillers, binders, disintegrants, lubricants, coatings and capsule shells.

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Trade & logistics

EXW

Ex Works

The seller makes goods available at its premises; the buyer arranges everything else, including export clearance. Rarely practical for imports into India.

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Trade & logistics

FCL / LCL

Full / less than container load

FCL means a shipment fills a whole container; LCL means it shares container space with other shippers' cargo.

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Grades & standards

Feed grade

A grade intended for animal-feed premixes, with specifications suited to feed regulations rather than human medicines.

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Formulation

Film coating

A thin polymer layer applied to tablets to protect them, mask taste, add colour or control release. Low-viscosity HPMC with a PEG plasticiser is typical.

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Chemistry

Fine chemical

A pure, single substance produced in limited volumes to a tight specification, used as a building block in pharmaceuticals, agrochemicals and dyes.

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Trade & logistics

FOB

Free On Board

The seller clears the goods for export and loads them on the buyer's nominated vessel; the buyer pays sea freight and insurance.

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Grades & standards

Food grade

incl. FCC

Material suitable for food use under food regulations (such as FSSAI in India) or the Food Chemicals Codex (FCC). Typical for vitamins used in fortification.

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Formulation

Fortification

Adding vitamins or minerals to foods – such as folic acid in flour – to improve nutritional value. Uses food-grade materials.

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Regulatory & safety

FSSAI

Food Safety and Standards Authority of India

The regulator for food safety in India, including fortified foods and nutraceuticals.

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Regulatory & safety

GHS

Globally Harmonized System

The UN system for classifying chemical hazards and communicating them through labels, pictograms and 16-section safety data sheets.

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Formulation

Glidant

An excipient that improves powder flow into tablet dies and capsule-filling machines, often colloidal silicon dioxide.

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Documents

GMP certificate

Good Manufacturing Practice

Evidence that a manufacturing site operates under GMP – the quality system that ensures products are consistently produced and controlled.

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Regulatory & safety

GST

Goods and Services Tax

India's indirect tax on supplies of goods and services. Imports attract IGST, which registered businesses can usually claim as input credit.

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Documents

Halal / Kosher certificate

Religious-compliance certificates requested for some nutraceutical and food applications, issued by recognised certifying bodies.

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Trade & logistics

HSN code

Harmonised System of Nomenclature

The internationally standard product classification code used for customs tariffs and GST rates.

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Chemistry

Hygroscopic

Readily absorbs moisture from the air. Hygroscopic materials such as povidone need tightly closed packaging and dry storage.

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Trade & logistics

IEC

Importer Exporter Code

A ten-character code issued by the DGFT that a business needs to import or export goods from India.

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Grades & standards

Impurity profile

The identity and quantity of impurities present in a material. Critical for API intermediates, because impurities can carry through into the final drug.

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Trade & logistics

Incoterms

International Commercial Terms

Standard trade terms published by the International Chamber of Commerce that define who pays for and arranges each leg of a shipment, and when risk passes.

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Trade & logistics

Indent

An order placed through an agent with an overseas producer, where the producer invoices the buyer directly and the buyer imports the goods in its own name.

Indenting service
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Trade & logistics

Indenting agent

An intermediary who arranges a purchase between a buyer and an overseas producer without buying or reselling the goods, usually paid a commission by the producer.

Indenting service
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Chemistry

Intermediate

A compound produced during the synthesis of an API that undergoes further chemical change before becoming the final active ingredient.

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Grades & standards

IP

Indian Pharmacopoeia

The official book of standards for drugs and excipients manufactured or sold in India, published by the Indian Pharmacopoeia Commission. Most domestic formulation plants specify IP grade.

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Grades & standards

JP

Japanese Pharmacopoeia

Japan's official drug standards. Relevant when sourcing excipients or intermediates from Japanese producers or supplying products for the Japanese market.

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Grades & standards

K-value

A number describing the average molecular weight of povidone (PVP). PVP K30 is the most common binder grade; K25 and K90 are used for other viscosities.

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Chemistry

KSM

Key Starting Material

A raw material that becomes a significant structural part of an API. Regulators expect its quality to be well controlled, because it shapes the API's impurity profile.

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Trade & logistics

LC

Letter of credit

A bank's undertaking to pay the seller once compliant shipping documents are presented. It protects both sides in international trade.

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Trade & logistics

Lead time

The time between confirming an order and receiving the goods, including production, packing and transport.

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Grades & standards

LOD

Loss on drying

The weight lost when a sample is dried under set conditions – a measure of moisture and volatile content, important for hygroscopic excipients.

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Formulation

Lubricant

An excipient that reduces friction during tablet compression and capsule filling. Magnesium stearate, typically at 0.25–1%, is the most common.

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Documents

MoA

Method of Analysis

The test procedures used to check a material against its specification, so the buyer's QC laboratory can repeat the analysis.

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Chemistry

Molecular formula

The number and type of atoms in a molecule – for example, C₆H₇NO for 4-Aminophenol.

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Chemistry

Molecular weight

The mass of one mole of a substance in g/mol. Polymers such as PEG and povidone are described by average molecular weight or grade.

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Grades & standards

Monograph

The pharmacopoeial entry for a single substance, setting its identity tests, assay limits, impurity limits and other quality requirements. A 'pharmacopoeial grade' material must meet its monograph.

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Trade & logistics

MOQ

Minimum order quantity

The smallest quantity a supplier will sell in one order, often linked to pack size or production batch.

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Formulation

ODT

Orally Disintegrating Tablet

A tablet that disperses in the mouth without water. Usually based on mannitol with a superdisintegrant.

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Chemistry

Oxime

A compound formed when an aldehyde or ketone reacts with hydroxylamine – an important step in several pharmaceutical and agrochemical routes.

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Grades & standards

Ph. Eur.

European Pharmacopoeia (EP)

The pharmacopoeia of the Council of Europe, maintained by the EDQM and binding in its member states. Material may be supported by a Certificate of Suitability (CEP).

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Grades & standards

Pharmacopoeial grade

Material that complies with a named pharmacopoeia monograph such as IP, BP, USP–NF or Ph. Eur. Used for ingredients that end up in a finished medicine.

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Formulation

Plasticiser

An additive that makes a film coating or capsule shell flexible rather than brittle – for example, PEG in HPMC coatings.

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Grades & standards

Polymorph

One of several crystal forms of the same compound. Different polymorphs can differ in solubility and stability, so the form is sometimes specified.

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Trade & logistics

Proforma invoice

PI

A preliminary invoice stating price, quantity, delivery term and payment terms. It is used to confirm an order and to open a letter of credit.

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Grades & standards

PSD

Particle size distribution

The spread of particle sizes in a powder. It affects flow, blending and compression – for example, the difference between MCC PH 101 and PH 102.

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Grades & standards

Purity

How much of a material is the intended substance. Often used interchangeably with assay, though purity may also consider all impurities together.

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Chemistry

Reagent

A substance used to bring about a chemical reaction. Unlike an intermediate, it does not become part of the final molecule.

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Grades & standards

Residual solvents

ICH Q3C

Traces of organic solvents left from manufacturing. ICH Q3C classifies solvents and sets limits; many QA teams request a residual-solvent statement.

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Documents

Retest date

The date by which a material should be re-examined to confirm it still meets specification. Expiry dates are used instead where stability data supports them.

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Documents

SDS

Safety Data Sheet (MSDS)

A 16-section document in GHS format describing hazards, safe handling, storage, first aid and transport information. Formerly called MSDS.

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Formulation

Softgel

Soft gelatin capsule

A one-piece capsule with a liquid or semi-solid fill – often an oil such as vitamin E acetate – sealed in a plasticised gelatin shell.

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Chemistry

Solubility

How much of a substance dissolves in a solvent at a given temperature. It affects formulation choices and, for APIs, how a drug is absorbed.

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Chemistry

Storage conditions

The temperature, humidity and light conditions needed to keep a material within specification, stated on the label, SDS and TDS.

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Formulation

Superdisintegrant

A highly efficient disintegrant – such as croscarmellose sodium – that swells rapidly in water and is effective at low concentrations.

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Formulation

Sustained release

SR / extended release

A dosage form that releases the drug slowly over time. High-viscosity HPMC grades are widely used to build sustained-release matrix tablets.

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Documents

TDS

Technical Data Sheet

A product-level document describing typical properties, grades, applications and packaging – useful when evaluating a material, but not batch-specific like a COA.

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Grades & standards

Technical grade

A grade defined by the manufacturer's own specification rather than a pharmacopoeia. Common for intermediates and reagents that are consumed in a reaction and purified out downstream.

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Documents

TSE/BSE statement

A declaration on the risk of transmissible spongiform encephalopathies for materials that are, or could be, animal-derived – such as gelatin and some stearates.

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Regulatory & safety

UN number

A four-digit number identifying a dangerous substance for transport – for example, UN 1836 for thionyl chloride.

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Grades & standards

USP–NF

United States Pharmacopeia – National Formulary

The US compendium of drug standards. Active ingredients appear in the USP section and excipient monographs in the National Formulary (NF). Required for products filed with the US FDA.

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Grades & standards

Viscosity grade

For cellulose ethers such as HPMC, the grade code indicates solution viscosity – low-viscosity E5 and E15 for coating, high-viscosity K4M to K100M for sustained release.

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Formulation

Wet granulation

Making granules by mixing powders with a binder solution, then drying and milling them before compression. Common for high-dose APIs such as paracetamol.

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Browse by subject

Six areas cover most of what buyers ask about – from pharmacopoeial grades to shipping documents.

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