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14 new reference standards and 18 replacement batches released in June 2020

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News
03 July 2020
Strasbourg, France

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The EDQM announces the availability of:

  • 14 New Ph. Eur. reference standards:

Catalogue code

Name

Unit Quantity

Price

Y0002211

Lysine acetylsalicylate

15 mg

79 EUR

Y0002210

Hawthorn dry extract for system suitability HRS

110 mg

79 EUR

Y0002207

Trifluridine impurity A CRS

0.002 mg

79 EUR

Y0002205

Latanoprost impurity H CRS

0.002 mg

1000 EUR

Y0002200

Mycophenolate for system suitability CRS

4000 mg

79 EUR

Y0002191

Vitexin-2-O-Rhamnoside CRS

10 mg

150 EUR

Y0002189

Latanoprost for system suitability CRS

2 mg

1000 EUR

Y0002184

Letrozole impurity A

0.0005 mg

79 EUR

Y0002181

Cyasterone CRS

10 mg

79 EUR

Y0002176

Mexiletine impurity A CRS

40 mg

79 EUR

Y0002212

DL-lysine acetylsalicylate impurity C

5 mg

79 EUR

Y0002209

Ganoderma dry extract for system suitability HRS

210 mg

79 EUR

Y0002190

Ganoderic acid A CRS

20 mg

79 EUR

Y0002213

DL-lysine acetylsalicylate impurity G

15 mg

79 EUR

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

Catalogue code

Name

Batch

Unit
Quantity

Price

Y0001645

Capecitabine impurity D CRS

2

10 mg

79 EUR

Y0000149

Rifabutin CRS

3

150 mg

79 EUR

C1650000

Chloroquine sulfate CRS

4

110 mg

79 EUR

N0300000

Neamine CRS

7

0.5 mg

79 EUR

Y0001766

Cisatracurium besilate CRS

2

130 mg

79 EUR

Y0001522

Anastrozole CRS

2

100 mg

79 EUR

Y0001330

Atorvastatin impurity C CRS

5

5 mg

79 EUR

Y0000786

Rosmarinic acid CRS

4

50 mg

79 EUR

Y0000492

Oxycodone hydrochloride - * narc CRS

2

70 mg

79 EUR

Y0001896

Oxytetracycline CRS

9

100 mg

79 EUR

Y0000916

Fluvoxamine impurity D CRS

2

10 mg

79 EUR

D1954000

Dihydrostreptomycin sulfate CRS

6

25

79 EUR

Y0001507

Megestrol acetate for peak identification CRS

2

20 mg

79 EUR

F0180000

Fludrocortisone acetate CRS

3

100 mg

79 EUR

T2000000

Trifluoperazine hydrochloride CRS

3

30 mg

79 EUR

I0380000

Isoconazole nitrate CRS

2

150 mg

79 EUR

E0180000

Enoxaparin sodium CRS

6

120 mg

79 EUR

Y0001629

Follitropin CRS

3

0.2 mg

79 EUR

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Information on reference standards removed from catalogue
 

  • 02/07/2021

Catalogue code

Name

Comments

C2332000

Clomifene citrate for performance test CRS

Removed from Ph. Eur. supplement 10.2 (in application from 01/07/2020) but kept on sales for an additional 6 months according to EDQM policy.

Y0001850

Oxytetracycline for system suitability CRS

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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 01 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”, 24 January 2020).

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).

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Information on change of sales units:

Fluoxetine impurity B CRS – F0253020 – changed from 1 to 3 vials.

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Information on change of price:

Please note that Everolimus CRS, Everolimus for system suitability CRS and Everolimus for impurity C identification CRS Batch 2 will be sold €300.

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Information on change of EDQM storage / shipping conditions:

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

  • Benzathine benzylpenicillin for peak identification CRS batch 1 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 with immediate effect for the following reference standard:

  • Cefepime dihydrochloride monohydrate for system suitablity CRS batch 3 is now stored at –20°C (previously +5°C) and shipped under Ice –20°C (previously ambient temperature).

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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.

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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 (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.

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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 is on your company letter headed paper stating both the catalogue code and substance name and attached to your email).

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