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15 new reference standards and 22 replacement batches released in June 2019

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04 July 2019
Strasbourg, France

The EDQM announces the availability of:

  • 15 New Ph. Eur. reference standards

Catalogue code

Name

Unit

Quantity

Y0002128

Carmustine

60 mg

Y0002122

Prasugrel hydrochloride

70 mg

Y0002119

Prasugrel for system suitability

10 mg

Y0002116

Propyl gallate for ID and assay

80 mg

Y0002114

Tapentadol impurity C

10 mg

Y0002113

Tapentadol impurity A

10 mg

Y0001995

Nicotinic acid for equipment qualification

250 mg

Y0002137

Alfacalcidol for impurity B identification

5 mg

Y0002135

Propranolol for system suitability

15 mg

Y0002125

Alfacalcidol for system suitability A

5 mg

Y0002123

Benzydamine Hydrochloride

10 mg

Y0002120

Tapentadol hydrochloride - * psy

80 mg

Y0002117

Tetracaine

10 mg

Y0002112

Dronedarone impurity B

10 mg

Y0002077

Procaine benzylpenicillin for peak identification

15 mg

 

  • 22 Replacement batches for Ph. Eur. reference standards

Catalogue code

Name

Batch

Unit Quantity

Y0001137

Clobetasone butyrate for system suitability

2

20 mg

Y0001131

Valsartan for peak identification

3

10 mg

P2939000

Prilocaine

2

150 mg

A0225000

Acitretin

3

100 mg

Y0001372

Cefprozil impurity A

2

20 mg

Y0001143

Terbinafine for system suitability

3

10 mg

N0750015

Nifedipine impurity B

2

25 mg

C2400000

Clonidine hydrochloride

2

25 mg

C0350000

Calcium oxalate monohydrate

2

100 mg

D0650000

Desmopressin

10

1 mg

Y0001542

Insulin glargine

5

15 mg

Y0001494

Hydrochlorothiazide for peak identification

4

10 mg

A0349000

Allantoin

2

60 mg

Y0001055

Tributyl acetylcitrate

3

1 mL

Y0000634

Cefepime dihydrochloride monohydrate for system suitability

3

15 mg

C0682800

Cefazolin

5

150 mg

C0650000

Cefadroxil

4

150 mg

Y0001600

Metformin impurity F

3

2 mL

Y0001510

Lactulose for peak identification

2

1900 mg

Y0001328

Atorvastatin impurity A

4

5 mg

Y0000263

Prekallikrein activator in albumin BRP

7

200 mg

F0450000

Framycetin sulfate

8

25 mg

 

Information on reference standards removed from catalogue

From 01/07/2019, the following Ph. Eur. standards have been removed from the catalogue:

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

From 01/07/2019, the number of vials per sales unit is increased from 2 to 3 for:

A0325450      Alfacalcidol

 

Information on the current non-availability of a reference standard

Ph. Eur. Somatropin/Desamidosomatropin resolution mixture CRS (Y0000711) is currently unavailable.

In order to overcome the temporary shortage of this CRS and until the replacement batch is made available, it is advised to prepare the system suitability resolution solution for the test of related proteins described in the monographs 0950 (Somatropin concentrated solution), 0951 (Somatropin) and 0952 (Somatropin for injection) by using the Ph. Eur. Somatropin CRS Batch 3 (Cat. No. S0947000).

See more information in the Note to users.

 

Content of the European Pharmacopoeia RS 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:

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