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8 new reference standards and 24 replacement batches released in October 2020

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Reference Standard
Collection & Catalogue
News
09 November 2020
Strasbourg, France

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The EDQM announces the availability of:

8 new European Pharmacopoeia (Ph. Eur.) reference standards:

 Catalogue code Name  Unit quantity  Price

Y0002235

Piperacillin for peak identification CRS

15 mg

79 EUR

Y0002222

Ticagrelor CRS

120 mg

79 EUR

Y0002221

Ticagrelor impurity E CRS

15 mg

79 EUR

Y0002234

Dexpanthenol impurity B CRS

15 mg

79 EUR

Y0002236

Sorafenib for peak identification CRS

15 mg

100 EUR

Y0002233

Sorafenib impurity H CRS

10 mg

100 EUR

Y0002224

Sorafenib tosilate CRS

120 mg

100 EUR

Y0002223

Ticagrelor for system suitability CRS

15 mg

79 EUR

 

  • 24 replacement batches for Ph. Eur. reference standards:
Catalogue code Name Batch Unit quantity Price

H0185000

Heparin Low-Molecular-Mass for assay BRP

11

1 mL

90 EUR

Y0001575

Bupivacaine impurity F CRS

3

70 mg

79 EUR

C0450000

Carbamazepine CRS

6

180 mg

79 EUR

Y0001925

Betamethasone dipropionate for system suitability A CRS

2

10 mg

79 EUR

Y0001765

Laudanosine CRS

2

15 mg

79 EUR

Y0001665

Progesterone for system suitability CRS

2

5 mg

79 EUR

Y0001237

Nimesulide for peak identification CRS

3

10 mg

79 EUR

Z1904000

Zidovudine impurity B CRS

4

5 mg

79 EUR

Y0001640

Indometacin impurity mixture CRS

2

0.002 mg

79 EUR

Y0001163

Ursodeoxycholic acid for system suitability CRS

4

1.26 mg

79 EUR

Y0000866

Sertraline for peak identification CRS

6

5.4 mg

79 EUR

Y0000528

Sulbactam CRS

3

150 mg

79 EUR

R0950000

Rifamycin S CRS

4

100 mg

79 EUR

Y0001332

Atorvastatin impurity E CRS

5

5 mg

79 EUR

Y0001084

Acetazolamide for system suitability CRS

3

0.0068 mg

79 EUR

Y0000080

Articaine impurity A CRS

4

20 mg

79 EUR

Y0000503

Atracurium for impurity F identification CRS

2

15 mg

79 EUR

Y0000298

Fluphenazine octanoate CRS

5

20 mg

79 EUR

P0500000

Pentobarbital CRS - * psy

3

100 mg

79 EUR

L0551000

Levonorgestrel CRS

3

30 mg

79 EUR

Y0001994

Human immunoglobulin for anticomplementary activity BRP

2

10 g

79 EUR

Y0001900

Dicycloverine impurity A CRS

2

20 mg

79 EUR

P2400000

Polymyxin B sulfate CRS

7

25 mg

79 EUR

D0730000

Dexpanthenol CRS

6

20 mg

79 EUR

 

Information on reference standards removed from catalogue

None.

 

Information on reference standards with a future removal from catalogue

Following the implementation of Supplement 10.3, the following standards are officially withdrawn as of 1 January 2021. 

Catalogue code Name Comments

Y0000055

Acamprosate calcium - reference spectrum

Removed from Ph. Eur. supplement 10.3 (in application from 1 January 2021) but kept on sales for an additional 6 months according to new policy (see “Change in the policy for withdrawing reference standards from sale”).

F0253000

Fluoxetine hydrochloride

O0120010

Ofloxacin impurity A

M0400000

Meprobamate CRS

Y0000035

Carisoprodol CRS

Y0000036

Carisoprodol impurity A CRS

N0050000

Nalidixic acid CRS

Y0001792

Nalidixic acid impurity C CRS

P2800000

Prednisolone acetate

Y0000369

Primidone for peak identification

Y0000239

Celiprolol for peak identification

Y0000312

Celiprolol impurity I

B1000000

Betamethasone

Y0000883

Adrenaline with impurity F

Y0001128

Epinastine for system suitability

These standards will nevertheless remain available for sale, subject to sufficient stock, until the end of June 2021. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 31 December 2021) to allow users to print the batch validity statement (BVS).

 

Information on change of sales units

None.

 

Information on change of price

Please note the price change for Batch 2 of Everolimus CRS products, i.e. Everolimus for system suitability CRS and Everolimus for impurity C identification CRS, to €300 per sales unit.

 

Information on change of EDQM storage/shipping conditions

None.

 

Content of the European Pharmacopoeia RS catalogue

The EDQM proposes more than 3 000 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 daily and can be downloaded in 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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