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1 new reference standard and 29 replacement batches released in January 2020

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Products and Services
News
05 February 2020
Strasbourg, France

Information for Indian users

Shipments to China

See also:

Content of the Ph. Eur. RS catalogue
How to place an RS order


The EDQM announces the availability of:

  • 1 new European Pharmacopoeia (Ph. Eur.) reference standard:

Catalogue code

Name

Unit quantity

Y0002178

Clomifene for system suitability CRS

25 mg

 

  • 29 replacement batches for Ph. Eur. reference standards:

Catalogue code

Name

Batch

Unit quantity

Y0000556

Febantel CRS

3

150 mg

N0020000

Nabumetone CRS

2

60 mg

L0376000

Leuprorelin CRS

6

1 mg

Y0000624

Terazosin impurity N CRS

2

10 mg

Y0000719

Paclitaxel semi-synthetic for peak identification CRS

3

10 mg

C3250000

Cyclophosphamide CRS

4

50 mg

Y0001603

Dutasteride for system suitability CRS

2

10 mg

Y0000515

Glimepiride CRS

3

110 mg

I0150020

Indapamide impurity B CRS

5

10 mg

Y0001850

Oxytetracycline for system suitability CRS

5

15

Y0001556

Ciclesonide impurity C CRS

2

10 mg

Y0001329

Atorvastatin impurity B CRS

5

10 mg

Y0001105

Drospirenone CRS

2

80 mg

Y0000079

Articaine hydrochloride CRS

4

200 mg

Y0000877

Bisoprolol for peak identification CRS

4

1 mg

S0808060

Sodium stearyl maleate CRS

3

15 mg

Y0001520

Pioglitazone hydrochloride CRS

2

120 mg

Y0001005

Dydrogesterone impurity A CRS

2

6 mg

Y0000887

Cyclizine impurity B CRS

2

15 mg

Y0001047

Teicoplanin for identification CRS

2

50 mg

Y0000787

Caffeine for system suitability CRS

6

10 mg

Y0000032

Salbutamol impurity I CRS

5

0.006 mg

T2900000

Tyrosine CRS

3

50 mg

C2360000

Clomipramine hydrochloride CRS

2

50 mg

I0200000

Indometacin CRS

4

70 mg

Y0000420

Cefotaxime acid CRS

4

20 mg

N0399004

Neohesperidin-dihydrochalcone impurity B CRS

3

10 mg

F0550000

Fructose CRS

2

100 mg

C0200000

Calcitonin (salmon) CRS

12

1 mg

 

Information on reference standards removed from catalogue

  • 01/01/2020

Catalogue code

Name

Comments

C2725000

Copovidone - reference spectrum

Replaced by Y0002138 Copovidone CRS

C0580004

Carmustine - reference spectrum

Replaced by Y0002128 Carmustine CRS

N1279000

Norpseudoephedrine hydrochloride CRS - * psy

 

P3640000

Propyl gallate CRS

Replaced by Y0002116 Propyl gallate for ID and assay CRS

Y0000756

Fenoterol for peak identification CRS

 

Y0000779

Chlortalidone for peak identification CRS

Replaced by Y0002129 Chlortalidone for system suitability CRS

Y0001079

Benserazide for peak identification CRS

Replaced by Y0002115 Benserazide for peak identification A CRS

P3600000

Propranolol hydrochloride for performance test CRS

 

Y0001601

Alfacalcidol for system suitability CRS

 


Information on reference standards with a future removal from catalogue

  • 01/04/2020

Catalogue code

Name

Comments

F0230000

Fluocortolone pivalate CRS

 

N1080000

Nomegestrol acetate CRS

 

P2804000

Prednisolone hexanoate CRS

 

Y0000342

Testosterone for impurity D identification CRS

 

Y0000343

Testosterone for system suitability CRS

Replaced by Y0002174 Testosterone for system suitability A CRS

Y0000570

Clobetasol for peak identification CRS

 

Z2500010

Zolpidem impurity A CRS

 

 

  • 02/07/2021

Catalogue code

Name

Comments

C2332000

Clomifene citrate for performance test CRS

Removed from Ph. Eur. supplement 10.2 (in application from 01/07/2020) but kept on sales for an additional 6 months according to new policy (see "Change in the policy for withdrawing reference standards from sale").

Y0001850

Oxytetracycline for system suitability CRS


Information on change of sales units

None.


Information on change of EDQM storage/shipping conditions

In order to ensure better stability, storage and shipping conditions have been changed for the following reference standard from 15/01/2020:

Enalapril impurity mixture A CRS batch 2 is stored at –20 °C and shipped at +5 °C.


Change in the policy for withdrawing reference standards from sale

A new policy will be applied from the application of Supplement 10.2 (01/07/2020). Detailed information is available in the news item of 24 January 2020.


 Information for Indian users: shipment of Oxytocin CRS to India

The Ministry of Health and Family Welfare of India has lifted the ban on Oxytocin reference standards imported exclusively for the purpose of test and analysis.

The EDQM is therefore now in a position to ship Oxytocin CRS and Oxytocin/Desmopressin validation mixture CRS (catalogue code O0700000 and O0770000) to India once again.


 Shipments to China

The shipping company working with the EDQM has cancelled all its flights to Beijing and Shanghai until 28/02/2020. As the situation may change quickly, we will inform our users as soon as possible via the EDQM web page.


Information on the current non-availability of a reference standard

Ph. Eur. Somatropin/Desamidosomatropin resolution mixture CRS (Y0000711) is currently unavailable.

To overcome the temporary shortage of this CRS and until the replacement batch is made available, it is advised to prepare the system suitability resolution solution for the test of related proteins described in the monographs 0950 (Somatropin concentrated solution), 0951 (Somatropin) and 0952 (Somatropin for injection) by using the Ph. Eur. Somatropin CRS Batch 3 (Cat. No. S0947000).

See more information in the Note to users.


Content of the European Pharmacopoeia RS catalogue

The EDQM proposes more than 3000 Ph. Eur. RS, including a wide range of highly characterised chemical reference substances (CRS), herbal reference standards (HRS) and biological reference preparations (BRP), as well as reference spectra for the tests and assays to be carried out in accordance with the official methods prescribed in the Ph. Eur. The Ph. Eur. RS catalogue is updated on a daily basis and gives access not only to all the Ph. Eur. RS, but also to:

  • Batch Validity Statements (BVSs) for each reference standard;

  • Safety Data Sheets and Safety Data Statements for hazardous biologicals;
  • leaflets (downloadable PDFs).

For your convenience, the Ph. Eur. RS catalogue is published on a daily basis and can be downloaded in PDF format and in XML format.


How to place an RS order

If you wish to place an order, you can send your request to the EDQM either:

  • via the web store (this form can also be used to confirm a proforma invoice or a quotation you have already received from the EDQM);

  • or by e-mail to orders@edqm.eu (in this case, please ensure that your order, on your company letterhead, states both the catalogue code and substance name and is attached to your e-mail).
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