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9 new reference standards and 10 replacement batches released in December 2020

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News
04 January 2021
Strasbourg, France

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The EDQM announces the availability of:

  • 9 new European Pharmacopoeia (Ph. Eur.) reference standards:

Catalogue code

Name

Unit quantity

Price

Y0002255

Sulindac for system suitability

15 mg

79 EUR

Y0002251

Clomifene for peak identification

20 mg

79 EUR

Y0002250

Nickel solution

10 mL

79 EUR

Y0002220

Monotropein CRS

10 mg

150 EUR

Y0002256

Fludarabine for peak identification

15 mg

79 EUR

Y0002245

Aciclovir for system suitability A CRS

20 mg

79 EUR

Y0002244

Aciclovir for impurity G identification

0.004 mg

79 EUR

Y0002242

Aciclovir for impurity C identification CRS

0.3 mg

79 EUR

Y0002265

Procaine benzylpenicillin for peak identification A

15 mg

79 EUR

 

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

Catalogue code

Name

Batch

Unit quantity

Price

S1000000

Sorbitol CRS

5

1250 mg

79 EUR

B1141000

Bleomycin sulfate CRS

3

7 mg

79 EUR

B1103000

Betaxolol hydrochloride CRS

3

60 mg

79 EUR

S1400000

Streptomycin sulfate CRS

5

100 mg

79 EUR

L0130000

Lactulose CRS

5

4120 mg

79 EUR

C0692000

Ceftriaxone impurity A CRS

6

10 mg

79 EUR

Y0000471

Buspirone for system suitability CRS

4

2 mg

79 EUR

G0460000

Monoammonium glycyrrhizate CRS

6

300

79 EUR

Y0001580

Rocuronium bromide CRS

2

20 mg

79 EUR

Y0002150

Rosuvastatin for peak identification CRS

2

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Following the implementation of Supplement 10.3, the following standards are officially withdrawn as of 1 January 2021.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

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

  • Etodolac for peak identification CRS batch 3 is now stored at –20°C (previously +5 °C) and shipped under Ice –20°C (previously ambient temperature).

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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