Back 7 new reference standards and 26 replacement batches released in April 2021

The EDQM announces the availability of: 7 new European Pharmacopoeia (Ph. Eur.) reference standards and 26 replacement batches for Ph. Eur. reference standards.
EDQM Strasbourg, France 06/05/2021
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7 new reference standards and 26 replacement batches released in April 2021

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The EDQM announces the availability of:

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

Catalogue code

Name

Unit quantity

Price

Y0002274

Fluticasone furoate CRS

70 mg

79 EUR

Y0002295

Nitrofural for peak identification A

0.11 mg

79 EUR

Y0002294

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

30 mg

79 EUR

Y0002285

Croscarmellose sodium CRS

20 mg

79 EUR

Y0002276

Dipotassium clorazepate monohydrate-*psy

15 mg

79 EUR

Y0002271

Flurbiprofen for peak identification CRS

20 mg

79 EUR

Y0002281

Somatostatin impurity F CRS

0.01 mg

90 EUR

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

Catalogue code

Name

Batch

Unit quantity

Price

Y0000153

Tianeptine impurity A CRS

2

80 mg

79 EUR

A1271000

Arginine hydrochloride CRS

4

60 mg

79 EUR

B1116000

Biotin CRS

4

20 mg

79 EUR

Y0000551

Doxazosin impurity D CRS

2

15 mg

79 EUR

Y0000763

Fluorouracil impurity B CRS

2

15 mg

79 EUR

H1120000

Hydralazine hydrochloride CRS

2

20 mg

79 EUR

R0145005

Ramipril impurity A CRS

5

20 mg

79 EUR

T2005010

Triflusal impurity B CRS

2

15 mg

79 EUR

Y0000834

Valaciclovir hydrochloride (anhydrous) CRS

2

210 mg

79 EUR

C2170000

Cilastatin sodium CRS

4

25 mg

79 EUR

Y0000881

Ibuprofen for peak identification CRS

10

0.09 mg

79 EUR

Y0001039

Meloxicam impurity D CRS

4

20 mg

79 EUR

Y0001184

Trolamine impurity A CRS

3

250 mg

79 EUR

Y0000722

Codeine CRS - * narc (Codeine monohydrate)

2

25 mg

79 EUR

D2255000

Dinoprost trometamol CRS

2

60 mg

79 EUR

Y0001966

Human immunoglobulin for Fc function BRP

2

10 mL

90 EUR

Y0000257

Lactobionic acid CRS

3

100 mg

79 EUR

A1300000

Ascorbic acid CRS

5

70 mg

79 EUR

Y0001264

Aciclovir for system suitability CRS

2

20 mg

79 EUR

Y0000273

Oxaliplatin impurity C CRS

7

20 mg

79 EUR

T1810000

Tranexamic acid CRS

6

20 mg

79 EUR

Y0001527

Aescin for LC assay HRS

2

150 mg

79 EUR

Y0002050

Betacarotene CRS

3

110 mg

79 EUR

D1980000

Diltiazem hydrochloride CRS

6

100 mg

79 EUR

K2000010

Ketoprofen impurity A CRS

7

15 mg

79 EUR

M0252600

Mefenamic acid CRS

3

50 mg

79 EUR

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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

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  • 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

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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

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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 17 May 2021 for the following reference standards:

Name

Catalogue Code

Batch

Current shipping conditions

New shipping conditions

Equine influenza subtype 1 strain A/eq/Newmarket/77 h a BRP

E0850010

2

Ice –20

Ambient temp.

Equine influenza subtype 2 American-like/Newmarket/1/93 h a BRP

E0850021

2

Equine influenza subtype 2 European-like/Newmarket/2/93 h a BRP

E0850022

2

Equine influenza subtype 2 American-like/South Africa/4/03 h a BRP

Y0000712

1

Equine influenza subtype 2 American-like strain A/Eq/Richmond/1/2007 h

Y0001874

1

Bordetella pertussis mouse antiserum BRP

B1142000

2

Etanercept BRP

Y0002042

1

Infliximab BRP

Y0002110

1

Human tetanus immunoglobulin BRP

H1110000

2

Tetanus vaccine BRP

T0400000

3

Endotoxin standard BRP

E0150000

5

Erythropoietin BRP

E1515000

5

Erythropoietin for physicochemical tests BRP

Y0001725

1

Erythropoietin for SEC BRP

Y0002009

1

Human coagulation factor VII concentrate BRP

Y0000667

2

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Please note that due to their stability profile these standards may be shipped at ambient temperature, but that they should be stored at –20°C upon receipt.

 

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 [email protected] (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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