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9 new reference standards and 22 replacement batches released in June 2021

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Reference Standard
Collection & Catalogue
News
07 July 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

Y0002296

Alfacalcidol impurity B

15 mg

300 EUR

Y0002298

Formoterol for system suitability

10 mg

79 EUR

Y0002291

Chenodeoxycholic acid for peak identification

50 mg

79 EUR

Y0002290

Chenodeoxycholic acid for system suitability

50 mg

79 EUR

Y0002278

Methylaminolevulinate impurity B

30 mg

79 EUR

Y0002273

Fluticasone furoate for peak identification

10 mg

79 EUR

Y0002293

Fluticasone furoate for system suitability CRS

15 mg

79 EUR

Y0002270

Trazodone for system suitability CRS

10 mg

79 EUR

Y0002269

Trazodone hydrochloride CRS

70 mg

79 EUR

 

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

Catalogue code

Name

Batch

Unit quantity

Price

C0470000

Carbocisteine CRS

3

40 mg

79 EUR

D2050000

Dimethyl sulfoxide CRS

4

1 mL

79 EUR

Y0002008

Sulfobutylbetadex impurity C CRS

2

40 mg

79 EUR

T0210000

Testosterone caproate CRS

2

20 mg

79 EUR

Y0000816

Atropine impurity B CRS

4

15 mg

79 EUR

Y0001331

Atorvastatin impurity D CRS

6

5 mg

79 EUR

Y0001035

Meloxicam impurity A CRS

3

15 mg

79 EUR

Y0001019

Cisplatin impurity B CRS

3

15 mg

79 EUR

H1000000

Human immunoglobulin for electrophoresis BRP

4

50 mg

79 EUR

F0253020

Fluoxetine impurity B CRS

8

15 mg

79 EUR

Y0000221

Fluticasone impurity D CRS

5

15 mg

79 EUR

S0600000

Silicone oil CRS

3

1 mL

79 EUR

T2610000

Tryptophan CRS

3

100 mg

79 EUR

Y0001174

Cefradine impurity mixture CRS

2

0.04

79 EUR

H0325000

Hexetidine CRS

3

100 mg

79 EUR

K0100000

Kanamycin B sulfate CRS

4

20 mg

79 EUR

T0240000

Testosterone decanoate CRS

4

60 mg

79 EUR

D0070000

Dalteparin sodium CRS

4

250 mg

79 EUR

Y0001102

Teicoplanin CRS

3

50 mg

79 EUR

Y0000155

Tramadol hydrochloride CRS

4

50 mg

79 EUR

Y0000760

Vinpocetine impurity D CRS

3

15 mg

79 EUR

X0100000

Xylometazoline hydrochloride CRS

4

100 mg

79 EUR


Information on reference standards removed from catalogue

  • 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

 

  • Supplement 10.5

Following the implementation of Supplement 10.5, the following standards are officially withdrawn from 1 July 2021.

Catalogue code

Name

Comments

D1750000

Diflunisal

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 1 July 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.

Y0000334

Codeine impurity A (O-methylcodeine)

Y0001641

Zidovudine for system suitability

Y0000361

Ciclosporin for system suitability

T0700000

Theobromine

 


Information on reference standards with a future removal from catalogue

  • Supplement 10.6

Following the implementation of Supplement 10.6 (1 January 2022), the following standards will be removed from the catalogue.

Catalogue code

Name

Comments

B0300000

Barbital

These standards will nevertheless remain available for sale, subject to sufficient stock, until the end of June 2022. Likewise, they will remain in the catalogue for a period of 12 months (i.e. until 1 January 2023) to allow users to print the batch validity statement (BVS). See “Change in the policy for withdrawing reference standards from sale” for more details.

Y0000623

Terazosin impurity L

 

The following standards will also be removed and replaced.

Items removed

Catalogue code

Replaced by

Catalogue code

Bisacodyl for system suitability

Y0000694

Bisacodyl for system suitability A

Y0002272

Dipotassium clorazepate - reference spectrum

D2750100

Dipotassium clorazepate monohydrate CRS

Y0002276

Terazosin for system suitability

Y0000666

Terazosin for system suitability A CRS

Y0002286

Terazosin impurity A

Y0000622

Terazosin for system suitability A CRS

Y0002286

Nitrofural for peak identification

Y0001377

Nitrofural for peak indentification A CRS

Y0002295

Pravastatin 1,1,3,3-tetramethylbutylamine

Y0000204

Pravastatin 1,1,3,3-tetramethylbutylamine for assay CRS

Y0002294

 

 

Information on change of sales units

Cholesterol CRS, C2155000 – As of 6 July 2021, the sales unit is changed from one unit to two.


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, storage and shipping conditions will be simplified on 15 July 2021 for the following reference standard:

  • Beta-sitosterol (Y0001615) CRS batch 1 will be stored at +5°C (previously –20°C) and shipped at ambient temperature (previously Ice –20°C).

Due to a stability issue, storage and shipping conditions have been modified, as of 17 June 2021, for the following reference standard:

  • Benzylpenicillin for system suitability (Y0001889) CRS batch 1 is stored at –20°C (previously +5°C) and shipped under Ice –20°C (previously ambient).

Due to a stability issue, shipping conditions have been modified, as of 1 July 2021, for the following reference standard:

  • Prilocaine (P2939000) CRS batch 2 is shipped under Ice +5°C (previously ambient).

 

NEW: Please be advised that as of July 2021, EDQM reference spectra will be sent exclusively by e-mail in PDF format and no longer in paper format by courier.

Therefore, within 48 hours of your order confirmation, you will receive a “Prior to dispatch” note and, in a separate e-mail, the PDF of your reference spectrum.

Please note that the PDF of the reference spectrum will be sent exclusively to the delivery contact stated on the order (in the “Delivered to” part of your Order confirmation). Only one delivery contact can be specified per order.

For any further information, please contact us via our HelpDesk.


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 WebStore;
  • 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).

A video “How to place an order through the reference standards WebStore” is available to help user ordering through the RS WebStore.

 

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