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2 new reference standards and 18 replacement batches released in August 2019

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05 September 2019
Strasbourg, France

The EDQM announces the availability of:

  • 2 New Ph. Eur. reference standards:

Catalogue code

Name

Unit

Quantity

Y0002173

Tilidine hydrochloride hemihydrate - * narc

20 mg

Y0002172

Tilidine for system suitability - * narc

10 mg

 

  • 18 Replacement batches for Ph. Eur. reference standards:

Catalogue code

Name

Batch

Unit Quantity

Y0001428

Pheniramine impurity A

2

20 mg

Y0000790

Vinpocetine impurity C

3

15 mg

S1200000

Spironolactone

5

160 mg

C0250000

Calcium folinate

8

110 mg

Y0001036

Meloxicam impurity B

3

5 mg

Y0001232

Fosinopril impurity I

2

5 mg

Y0000156

Tramadol impurity A

6

20 mg

S0710000

Sodium cetostearyl sulfate

2

100 mg

I0750000

Isopropyl tetradecanoate

5

2 mL

F0253030

Fluoxetine impurity C

5

5 mg

Y0000085

Aceclofenac impurity F

4

15 mg

R1000000

Rifamycin sodium

5

150 mg

O0288005

Oxybutynin impurity A

5

20 mg

Y0001798

Low-substituted hydroxypropylcellulose

2

50 mg

Y0000577

Pancuronium bromide for system suitability

2

15 mg

Y0000902

Racecadotril for peak identification

2

5 mg

N0905005

Nitrendipine impurity A

4

30 mg

C2210000

Cisplatin

7

100 mg

 

Information on reference standards removed from catalogue:

None.

 

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 change of EDQM storage / shipping conditions:

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

  • Cimetidine FSS CRS batch 2 is stored at -20°C and shipped at +5 °C (batch 1 was stored at +5 °C and shipped ambiant).

 

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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