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Adopted opinions and previous consultations on applications for authorisation

Adopted opinions and previous consultations on applications for authorisation

 

This page provides further information on the applications for authorisation or review reports, which have undergone public consultation. The applications for authorisation are in the opinion development phase until the final opinions of the Committees for Risk Assessment and Socio-economic Analysis have been adopted and sent to the European Commission. The European Commission's decision-making process can be followed through the comitology register, where further information is published about the REACH Committee's past and upcoming meetings.

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Substance Details

Name
Bis(2-methoxyethyl) ether
EC Number
203-924-4
CAS Number
111-96-6
Entry Nr in Annex XIV
25
Use name
Use of diglyme as a process solvent in one step of the manufacturing of an Active Pharmaceutical Ingredient used in an anti-protozoal drug
Broad information on use applied for (conditions of use and function)
Bis(2-methoxyethyl)ether (diglyme) is used as a process solvent in a closed system under Good Manufacturing Practice conditions. Diglyme plays a critical role in the reduction step of the complex manufacturing process of P2 (used as an active pharmaceutical ingredient (API) in an anti-protozoal drug).

The function of diglyme is to solubilize all reagents used in the process and to ensure the safety of the reactions. Being compatible with all chemicals involved in the API manufacturing process, the solvent satisfies industrial needs as promoting reaction yield and purity profile, and permits its efficient recycling. Diglyme has been established as a highly versatile polar aprotic solvent for reactions especially due to its chemical compatibility with and its capacity to solubilize the P2 precursor (P0), the reducing agent and the Lewis acid. Furthermore, the high boiling point of diglyme makes it easy to remove water by distilling the extraction solvent/water azeotrope without distilling diglyme.

For the established synthesis route, the key requirements of the solvent include:

  • Compatibility with all the chemicals involved through the process.
  • Solubilisation of the P2 precursor (P0), the reducing agent and the Lewis acid.
  • Efficiency of the reaction comparable to the diglyme reaction (yield=78%).
  • Ability to recover the solvent from the process and re-use it.
  • No change in the final API profile (P2).
  • Compliance with rules on solvent residues for pharmaceutical products.
Additional information on criteria for substance function and on the process are given in the joint Analysis of Alternatives and Socio-Economic Analysis on pp. 10-11 and 15-16.

Annual tonnage used: 22 – 35 tonnes
Review period requested: 12 years
Use applied for number in application for authorisation
1
Broad information on use applied for (Use descriptor system)
Sector of end use (SU): 9
Environmental release category (ERC): 4
Process category (PROC): 1, 3, 4, 8a, 8b, 9, 15
Product category (PC): 29
Technical Function: Solvents
Summary table of RMMs and OCs (non confidential)
Section 9 and 10 of the CSR (original and updated, if available) (non confidential)
Analysis of Alternatives (non confidential report)
Substitution Plan (non confidential summary)
Socio-Economic Analysis (non confidential report)
Joint Analysis of Alternatives and Socio-Economic Analysis (non confidential report)
Explanatory note
Additional information
ID
0089-01
Applicant(s)
PMC ISOCHEM [application transferred from original Applicant: ISOCHEM due to a notified legal entity change]
Application type
Initial
Status
Commission decided
Other consultations on the same/ similar use
0077-01
Comments submitted to date
No comments received
Response to comments by applicant
Responses to RAC and SEAC requests by Applicant(s) (non confidential)
Compiled RAC and SEAC opinions
Minority positions
Adopted commission decision (OJ summary)
Link
Authorisation decision
C(2019)5096

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