Classification of solvents as per ich guidelines
What are the Class 3 solvents?
Class 3 includes no solvent known as a human health hazard at levels normally accepted in pharmaceuticals. However, there are no long-term toxicity or carcinogenicity studies for many of the solvents in Class 3.
What is the class one solvents?
Organic solvents are commonly used in the pharmaceutical industry as reaction media, in separation and purification of synthesis products and also for cleaning of equipment.
Is DMSO a Class 3 solvent?
According to the European Pharmacopoeia and the United States Pharmacopeia dimethyl sulfoxide (DMSO) is a class 3 solvent and it is used in the pharmaceutical industry amongst others as an additive for the lyophilisation process.
What are the different classes of solvents?
Organic solvents and inorganic solvents are two types of solvents. Inorganic solvents don’t contain the element carbon. The most common inorganic solvents are water, and liquid ammonia whereas organic solvents, such as alcohols, glycol ethers, contain carbon and oxygen in their structure.
What is ICH limit?
The stated limit of 1500 ppm is based on a review of the safety data. TABLE 1. Class 1 solvents in pharmaceutical products (solvents that should be avoided).
Is acetic acid a 3rd class solvent?
The following compounds are indicated as Class 3 Residual Solvents: Acetic acid. Heptane. Acetone.
What class solvent is ethyl acetate?
Ethyl acetate is the acetate ester formed between acetic acid and ethanol. It has a role as a polar aprotic solvent, an EC 3.4.
Which solvents are also called Levelling solvents?
Strong bases are leveling solvents for acids, weak bases are differentiating solvents for acids. In a leveling solvent, many acids are completely dissociated and are thus of the same strength.
What is differentiating solvent?
In a differentiating solvent, various acids dissociate to different degrees and thus have different strengths. In a leveling solvent, several acids are completely dissociated and are thus of the same strength. A weakly basic solvent has less tendency than a strongly basic one to accept a proton.
What class solvent is toluene?
Class 2 –
[Residual Solvent Class 2 – Toluene (1.2 mL/ampule; 3 ampules)] – CAS 
What class of solvent is ethanol?
Solvent. Ethanol is considered a universal solvent, as its molecular structure allows for the dissolving of both polar, hydrophilic and nonpolar, hydrophobic compounds.
Is hexane a Class 2 solvent?
[Residual Solvent Class 2 – Hexane (1.2 mL/ampule; 3 ampules)] – CAS [110-54-3]
Is methanol a Class 2 solvent?
[Residual Solvent Class 2 – Methanol (1.2 mL/ampule; 3 ampules)] – CAS 
Is toluene polar or non polar?
Some of the examples of non-polar solvents include hexane, pentane, toluene, benzene, etc.
What xylene is used for?
It is primarily used as a solvent (a liquid that can dissolve other substances) in the printing, rubber, and leather industries. Along with other solvents, xylene is also widely used as a cleaning agent, a thinner for paint, and in varnishes.
What is PDE in residual solvents?
PDE: Abbreviation for permitted daily exposure. Permitted daily exposure: The maximum acceptable intake per day of residual solvent in pharmaceutical products.
What exactly is Class 1 residual solvent category?
4.1 Class 1: Solvents to Be Avoided
Class 1 residual solvents (Table 2) should not be used in the manufacture of drug substances, excipients, dietary ingredients, or official products because of their unacceptable toxicities or deleterious environmental effects.