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5 new reference standards and 21 replacement batches released in August 2020

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News
02 September 2020
Strasbourg, France

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The EDQM announces the availability of:

 

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

Catalogue code

Name

Unit quantity

Price

Y0002237

Piperacillin impurity I CRS

15 mg

79 EUR

Y0002229

Atorvastatin for system suitability CRS

15 mg

79 EUR

Y0002232

Streptomycin sulfate for identification

25 mg

79 EUR

Y0002246

Adrenaline impurity F CRS

0.008 mg

79 EUR

Y0002185

Ketoconazole impurity mixture CRS

0.03 mg

79 EUR

 

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

Catalogue code

Name

Batch

Unit quantity

Price

Y0001542

Insulin glargine CRS

6

15 mg

79 EUR

Y0000845

Atropine for peak identification CRS

4

0.25 mg

79 EUR

R1500000

Roxithromycin CRS

6

125 mg

79 EUR

Y0001173

Filgrastim CRS

3

0.3 mL

79 EUR

Y0000199

Ciprofloxacin hydrochloride for peak identification CRS

4

10 mg

79 EUR

U0020008

Ubidecarenone impurity D CRS

3

5 mg

79 EUR

Y0001101

Interferon beta-1a CRS

4

0.6 mL

90 EUR

Y0001071

Benserazide impurity C CRS

2

15 mg

79 EUR

Y0000711

Somatropin/desamidosomatropin resolution mixture CRS

2

3 mg

150 EUR

Y0001260

Trimebutine for system suitability CRS

3

1.02 mg

79 EUR

Y0001186

Salbutamol impurity J CRS

4

0.00045 mg

79 EUR

P1100000

Phenoxymethylpenicillin potassium CRS

5

260 mg

79 EUR

Y0000452

Morphine sulfate - * narc CRS

2

40

79 EUR

Y0001076

Losartan for system suitability CRS

4

0.0015 mg

79 EUR

Y0000527

Rocuronium for peak identification CRS

2

10 mg

79 EUR

C2190050

Ciprofloxacin impurity A CRS

6

25 mg

79 EUR

Y0002038

Marrubiin CRS

2

15 mg

79 EUR

Y0001839

Hydroxychloroquine sulfate CRS

2

70 mg

79 EUR

Y0001382

Levothyroxine for peak identification CRS

2

10 mg

79 EUR

P1240000

Phenylephrine CRS

3

50 mg

79 EUR

N0559000

Netilmicin sulfate CRS

2

25 mg

79 EUR

 

Information on reference standards removed from catalogue

None.

 

Information on reference standards with a future removal from catalogue

Following the implementation of Supplement 10.3, the following standards are officially withdrawn as of 1 January 2021.

Catalogue code

Name

Comments

Y0000055

Acamprosate calcium – reference spectrum

Removed from Ph. Eur. supplement 10.3 (in application from 1 January 2021) but kept on sales for an additional 6 months according to EDQM policy (see news bulletin “Change in the policy for withdrawing reference standards from sale”).

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

P2800000

Prednisolone acetate

Y0000369

Primidone for peak identification

Y0000239

Celiprolol for peak identification

Y0000312

Celiprolol impurity I

B1000000

Betamethasone

Y0000883

Adrenaline with impurity F

Y0001128

Epinastine for system suitability

 

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).

 

Information on change of sales units

None.

 

Information on change of price

Please note the price change for Batch 2 of Everolimus CRS products, i.e. Everolimus for system suitability 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 September 2020 for the following reference standard:

  • Cefepime impurity E CRS batch 2 will be stored at +5°C (previously –20°C) and shipped at ambient temperature (previously Ice –20°C).

 

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 European Pharmacopoeia. 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 updated on a daily basis and can be downloaded in PDF format and in XML format.

 

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 orders@edqm.eu (in this case, please ensure that your order, on your company letterhead, states both the catalogue code and substance name)
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