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12 new reference standards and 9 replacement batches released in November 2020

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News
02 December 2020
Strasbourg, France

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The EDQM announces the availability of:

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

Catalogue code

Name

Unit quantity

Price

Y0002264

N-Nitroso-dipropylamine

1 mL

79 EUR

Y0002263

N-nitroso-diisopropylamine

1 mL

79 EUR

Y0002262

N-nitroso-ethyl-isopropylamine

1 mL

79 EUR

Y0002261

N-Nitroso-dibutylamine

1 mL

79 EUR

Y0002260

N-nitroso-N-methyl-4-aminobutyric acid

1 mL

79 EUR

Y0002259

N-nitroso-dimethylamine

1 mL

79 EUR

Y0002258

N-Nitroso-diethylamine

1 mL

79 EUR

Y0002230

Morinda root for system suitabillity HRS

520 mg

79 EUR

Y0002226

Forsythoside A CRS

20 mg

79 EUR

Y0002171

Procaine benzylpenicillin impurity F CRS

0.025 mg

79 EUR

Y0002257

Pemetrexed disodium 2.5-hydrate CRS

15 mg

79 EUR

Y0002231

Prednicarbate for peak identification CRS

15 mg

79 EUR

 

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

Catalogue code

Name

Batch

Unit quantity

Price

Y0001401

Vigabatrin impurity A CRS

2

40 mg

79 EUR

T1550000

alpha-Tocopherol CRS

10

1.5 mL

79 EUR

Y0001812

Sitagliptin phosphate monohydrate CRS

2

120 mg

79 EUR

H0190000

Heparin Low-Molecular-Mass for calibration CRS

5

10 mg

170 EUR

Y0001973

Lacosamide for system suitability CRS

2

10 mg

79 EUR

C2158000

Cholic acid CRS

3

60 mg

79 EUR

Y0001687

Milk thistle dry extract HRS

3

120 mg

79 EUR

Y0000718

Lorazepam impurity D CRS

3

10 mg

79 EUR

P0309000

Pefloxacin mesilate dihydrate CRS

2

200 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Following the implementation of Supplement 10.3, the following standards are officially withdrawn as of 1 January 2021.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 new policy (see “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 15/12/2020 for the following reference standard:

  • Catalpol CRS batch 2 will be stored at +5°C (previously -20°C) and shipped at ambient temperature (previously Ice -20°C).

 

In order to ensure better stability, storage and shipping conditions will be changed on 15/12/2020 for the following reference standards:

  • Clotrimazole impurity E CRS batch 3 will be shipped under Ice +5 °C (previously ambient temperature) 
  • Pregabalin impurity A CRS batch 2 will be stored at -20 °C (previously +5 °C) and shipped under Ice -20 °C (previously ambient temperature)

 

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

  • Benzathine phenoxymethylpenicillin CRS batch 1 are now stored at -20 °C (previously +5 °C) and shipped under Ice -20 °C (previously ambient temperature)
  • Benzathine phenoxymethylpenicillin for system suitability CRS batch 1 are now stored at -20 °C (previously +5 °C) and shipped under Ice -20 °C (previously ambient temperature)

 

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.

 

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 and is attached to your e-mail).
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