Solvent Residue Analysis: Critical Tests in Food and Drug Safety

Why Solvent Residue Analysis?

Solvent residues are potential contaminants from organic solvents used in food, pharmaceuticals and cosmetics. These solvents may remain in trace amounts in products after use in production processes. Solvent residue analysis plays an important role in ensuring product safety by checking whether these residues are within legal limits.

What are Solvents?

They are liquid substances used to dissolve organic compounds or facilitate reactions. Examples include acetone, methanol, ethanol, hexane, toluene, dichloromethane.

What are the Sources of Solvent Residues?

Production Processes: Extraction, purification, granulation, coating processes.
Cleaning: Solvents used in disinfection of production equipment.

What are the Health Effects?

Solvent residues can cause acute or chronic toxicity, depending on the level and type of exposure. Liver damage, nervous system toxicity, carcinogenic risks are potential risks that may occur.

Legal Regulations for Solvent Residues

The International Pharmacopoeia (ICH Q3C) divides solvents into three categories:

Category 1: Prohibited solvents (e.g. benzene) - Carcinogenic and toxic.
Category 2: Limited solvents (e.g. toluene) - Limits that may pose a health risk.
Category 3: Solvents with low risk of toxicity (e.g. ethanol).

The amount of some extraction solvents allowed for use in some foods is as follows.

Hexane	1 mg/kg in fats or oils or cocoa butter.
Methyl acetate	20 mg/kg in tea and coffee
Ethyl methyl ketone	5 mg/kg in fats or oils
Dichloromethane	2 mg/kg in roasted coffee, 5 mg/kg in tea
Propan-2-ol	10mg/kg
Methanol	10mg/kg
Dimethyl Ether	0.009 mg/kg of defatted protein product

Solvent Residue Analysis in Food and Pharmaceutical Industry

a) Food Sector

Application Areas:

Extraction of vegetable oils.
Production of flavor components.
Purification of food additives.

b) Pharmaceutical Industry

Application Areas:

Synthesis of active pharmaceutical ingredients (APIs).
Tablet and capsule coating processes.
Extraction and crystallization processes.

c) Cosmetics Industry

Can be used in solvents, perfumes and cream bases.
Highly volatile solvents need to be analyzed.

Nanolab Laboratories Group continues to provide services within the scope of Solvent Residue Analysis. We also provide services in Hormone and Antibiotic Testing.

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