Butan-1-ol for chemical purification of pharmaceutical product was replaced by 1-methoxypropan-2-ol

Number

133-EN

Section

General Section

Use

Sector

Manufacture of bulk, large scale chemicals (including petroleum products)
Manufacture of fine chemicals

Function

Cleaning agent

Process

Other

Product category

washing ad cleaning products

Application

purification of pharmaceutical products

Abstract

Butan-1-ol was used for chemical purification of pharmaceutical products. It has several harmful properties regarding human health and it smells very bad. It was replaced by 1-methoxypropan-2-ol.

Substituted substances

Butan-1-ol

CAS No. 71-36-3 EC No. 200-751-6 Index No. 603-004-00-6

Chemical group

Alcohol

Classification: hazard statements

H226 Flammable liquid and vapour
H302 Harmful if swallowed
H335 May cause respiratory irritation
H336 May cause drowsiness or dizziness
H315 Causes skin irritation
H318 Causes serious eye damage

Alternative Substances

1-Methoxypropan-2-ol

CAS No. 107-98-2 EC No. 203-539-1 Index No. 603-064-00-3

Chemical group

Glycol ethers

Classification: hazard statements

H226 Flammable liquid and vapour
H336 May cause drowsiness or dizziness

Reliability of information

Evidence of implementation: there is evidence that the solution was implemented and in use at time of publication

Reason substitution

skin/respiratory sensitizing
physical hazards

Hazard Assessment

Substance to be substituted: Butan-1-ol is a flammable liquid and vapour, is harmful if swallowed, causes serious eye damage, causes skin irritation, may cause respiratory irritation and may cause drowsiness or dizziness. Alternative substance: 1-methoxypropan-2-ol.is a flammable liquid and vapour and may cause drowsiness or dizziness. Both the substituted and alternative substances are combustible, but the alternative substance is nevertheless less hazardous to human health.

Description of Substitution

Previously the company used butan-1-ol to purify pharmaceutical products. Butan-1-ol is flammable and has a strong smell. The idea for substitution resulted from a systematic review of unit operations of chemical engineering.Purification with butan-1-ol releases an unpleasant odour. With 1-methoxypropan-2-ol the odour problem is eliminated and also the process can proceed under a lower pressure compared to the previous situation. However, using butan-1-ol the purification results in a cleaner product.The alternative substance is less hazardous than the substituted one. The alternative substance is more expensive to buy, but it is used in lower quantities compared to Butan-1-ol. So overall the expense for purification chemicals has not changed during the substitution process.The substitution did not lead to any change in production equipment. Advantages: - No unpleasant odour - Purification is more efficient, in other words, the product will be cleaner - No change of production equipment- Less harmful chemical Disadvantages:- 1-methoxypropan-2-ol is slightly more expensive than butan-1-ol. - On the other hand, less quantities of 1-methoxypropan-2-ol are used resulting in very similar expenses for purification chemicals.

Case/substitution evaluation

The alternative is not included in the database of hazardous substances according to SUBSPORTplus screening criteria (SDSC), however according to the hazard statements it holds problematic properties. Among others, the risk of flammability has to be adequate controlled. Therefore, further research is needed to replace this substance in the future.

State of implementation

Full capacity

Date and place of implementation

1988, Denmark

Producer/Provider

www.leo-pharma.com

Type of information supplier

User

Date, reviewed

December 11, 2020