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1 new reference standard and 14 replacement batches released in March 2021

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News
07 April 2021
Strasbourg, France

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The EDQM announces the availability of:

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

Catalogue code

Name

Unit quantity

Price

Y0001913

Human albumin (molecular size) BRP

50 mg

90 EUR

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

Catalogue code

Name

Batch

Unit quantity

Price

Y0001979

Folic acid for system suitability CRS

2

10 mg

79 EUR

Y0000196

Ondansetron for TLC system suitability CRS

3

20 mg

79 EUR

Y0001680

Clindamycin phosphate for system suitability CRS

3

10 mg

79 EUR

Y0001998

Sulfobutylbetadex sodium CRS

2

850 mg

79 EUR

C0688000

Cefoxitin sodium CRS

4

100 mg

79 EUR

Y0000314

Estradiol for peak identification CRS

3

15 mg

79 EUR

C0630000

Cefaclor CRS

4

450 mg

79 EUR

Y0000639

Cladribine CRS

4

100 mg

79 EUR

Y0001355

Prednisolone for system suitability CRS

3

10 mg

79 EUR

H0920000

Human coagulation factor VIII concentrate BRP

6

40 mg

90 EUR

C0400000

Calcium pantothenate CRS

5

60 mg

79 EUR

P2155013

Plastic additive 13 CRS

3

180 mg

79 EUR

D2200000

Dimeticone CRS

5

450 mg

79 EUR

Y0001004

Dydrogesterone CRS

2

60 mg

79 EUR

 

Information on reference standards removed from catalogue

  • Supplement 10.3

Following the implementation of Supplement 10.3, the following standards are officially withdrawn from 1 January 2021.

 

Catalogue code

Name

Comments

Y0000055

Acamprosate calcium - reference spectrum

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). See “Change in the policy for withdrawing reference standards from sale” for more details.

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

Y0000369

Primidone for peak identification

Y0000239

Celiprolol for peak identification

Y0000312

Celiprolol impurity I

Y0000883

Adrenaline with impurity F

Y0001128

Epinastine for system suitability

 

  • Supplement 10.4

Following the implementation of Supplement 10.4, the following standards are officially withdrawn from 1 April 2021.

Catalogue code

Name

Comments

Y0001846

Erythromycin for impurity M identification

These standards will nevertheless remain available for sale, subject to sufficient stock, until the end of September 2021. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 31 March 2022) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details.

A0650000

Amobarbital - * psy

A0700000

Amobarbital sodium - * psy

D0630000

Desmethylmetrifonate

M1845000

Metrifonate

Y0001328

Atorvastatin impurity A

Y0001329

Atorvastatin impurity B

Y0001330

Atorvastatin impurity C

Y0001331

Atorvastatin impurity D

Y0001264

Aciclovir for system suitability

Y0001755

Fluticasone propionate for impurity G identification

Y0001271

Aciclovir for peak identification 1

Y0002077

Procaine benzylpenicillin for peak identification

Y0001269

Aciclovir for peak identification 2

 

Information on reference standards with a future removal from catalogue

  • Supplement 10.5

Following the implementation of Supplement 10.5 (1 July 2021), the following standards will be removed from the catalogue:

Diflunisal

D1750000

Codeine impurity A (O-methylcodeine)

Y0000334

Theobromine

T0700000

 

The following standards will also be removed and replaced:

Items removed

Catalogue code

Replaced by

Catalogue code

Zidovudine for system suitability

Y0001641

Zidovudine for system suitability A

Y0002266

Ciclosporin for system suitability

Y0000361

Ciclosporin for system suitability A

Y0002292

NB These standards will nevertheless remain available for sale, subject to sufficient stock, until the end of December 2021. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 30 June 2022) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details.

Information on change of sales units

None.

Information on change of price

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

Information on change of EDQM storage/shipping conditions

Based on new stability information, shipping conditions were simplified on 15 March 2021 for the following reference standards:

  • Omeprazole for peak identification (Y0001042) CRS batch 2 is shipped at ambient temperature (previously Ice –20°C);
  • Biotin for system suitability (Y0001978) CRS batch 1 is shipped at ambient temperature (previously Ice –20°C);
  • Colistin for system suitability (Y0001999) CRS batch 1 is shipped at ambient temperature (previously Ice –20°C).

In order to ensure better stability, shipping conditions were changed on 15 March 2021 for the following reference standard:

  • Enalapril impurity A mixture CRS (Y0001853) batch 2 is shipped under Ice –20 °C (previously Ice +5°C).

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.

When stocks of a given reference standard are low, the EDQM reserves the right to limit the quantities sold to each user to ensure that as many users as possible will receive at least some of the quantities available. Restrictions on quantities are applied at the time the purchase order is received.

Following a request from many users, the quantity allowed for each user is now directly displayed in the detailed view of the online catalogue.

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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