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11 new reference standards and 28 replacement batches released in July 2019

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06 August 2019
Strasbourg, France

The EDQM announces the availability of:

  • 11 new Ph. Eur. reference standards:

Catalogue code

Name

Unit

Quantity

Y0002134

Topiramate

70 mg

Y0002133

Topiramate impurity A

20 mg

Y0002132

Topiramate impurity E

40 mg

Y0002115

Benserazide for peak identification A

10 mg

Y0002102

Fenoterol for system suitability

0.13 mg

Y0002127

Mesterolone for system suitability

15 mg

Y0002124

Vincamine

10 mg

Y0002121

Dronedarone hydrochloride

120 mg

Y0002136

Oxytetracycline for system suitability A

20 mg

Y0002129

Chlortalidone for system suitability

1.02 mg

Y0002118

Benzydamine for system suitability

10 mg

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

Catalogue code

Name

Batch

Unit Quantity

T0060000

Terconazole

3

180 mg

M0120010

Malathion impurity B

4

15 mg

G0550000

Gramicidin

2

250 mg

G0342000

Glipizide impurity A

2

15 mg

D2250000

Dinoprostone

4

60 mg

P0305000

Parnaparin sodium

4

200 mg

Y0001579

Sildenafil impurity A

2

5 mg

Y0001060

Benzalkonium chloride for system suitability

5

20 mg

Y0000643

Glipizide impurity D

2

10 mg

Y0000558

Fluconazole for peak identification

2

10 mg

S0808000

Sodium stearyl fumarate

2

50 mg

E2400000

Ethylnicotinamide

2

100 mg

Y0000275

Dichlorodiaminocyclohexaneplatinum

6

15 mg

F0189900

Flunarizine dihydrochloride

4

50 mg

Y0001544

Insulin glargine for peak identification

2

3.2 mg

D0120000

Daunorubicinone

4

15 mg

Y0000103

Carvedilol impurity C

3

15 mg

P0309020

Pefloxacin impurity B

2

10 mg

Y0000306

Azithromycin

5

410 mg

M0600905

Metamizole impurity A

5

15 mg

C1350000

Chloramphenicol disodium disuccinate

4

45 mg

Y0001268

Nicotinic acid impurity mixture

2

0.12 mg

F0253000

Fluoxetine hydrochloride

6

250 mg

Y0001129

Ganciclovir

2

120 mg

P2155017

Plastic additive 17

3

250 mg

O0120050

Ofloxacin impurity E

5

20 mg

C2385015

Clonazepam impurity B

3

5 mg

Y0001813

Gefitinib

2

100 mg

 

Information on reference standards removed from catalogue:

Since 1 July 2019, the following Ph. Eur. standards have been removed from the catalogue:

Catalogue code

Name

Y0001224

Xylazine impurity mixture

Y0000717

Moxifloxacin for peak identification

Y0000322

Loperamide hydrochloride for system suitability

Y0000158

Xylazine impurity C

Y0000078

Flupentixol impurity F

Y0000067

Flupentixol impurity D

D1952000

Dihydroergotamine tartrate

 

Information on change of sales units:

SInce 1 July 2019, the number of vials per sales unit has been increased from 2 to 3 for the following Ph. Eur. standards:

Catalogue code

Name

A0325450     

Alfacalcidol

 

Information on changes of storage / shipping conditions:

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

  • Lacosamide FSS CRS batch 1: stored at -20°C and shipped at +5°C, as of 11 July 2019.
  • Neamine CRS batch 6: stored at -20°C and shipped at -20°C, as of 11 July 2019.
  • Podophyllotoxin CRS (Y0002002) and Podophyllotoxin FSS CRS (Y0002034): stored at +5°C and shipped at room temperature, as of 19 August 2019.

 

Note: all orders confirmed before the change date will be shipped with conditions valid at the time. This has no impact on the quality of the standard.

 

Information on reference standards currently out of stock:

Ph. Eur. Somatropin/Desamidosomatropin resolution mixture CRS (Y0000711) is currently unavailable. During this temporary shortage and until the replacement batch becomes made available, users of this CRS are advised to use the Ph. Eur. Somatropin CRS Batch 3 (Cat. No. S0947000) to prepare the system suitability solution for the tests described in monographs 0950 (Somatropin concentrated solution), 0951 (Somatropin) and 0952 (Somatropin for injection).

See more information in the Note to users.

 

The Ph. Eur. Reference Standards catalogue

The EDQM proposes more than 2900 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 European Pharmacopoeia (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 pdf).

For your convenience, the Ph. Eur. RS catalogue is published on a daily basis and can be downloaded in PDF format here as well as in XML format here.

 

How to place an RS order

If you wish to place an order, you can send your request to the EDQM either:

  • through 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 email to orders@edqm.eu (in this case, please ensure that your order is on your company letterhead paper stating both the catalogue code and substance name, and attached to your email).
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