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6 new reference standards and 20 replacement batches released in July 2020

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Products and Services
News
05 August 2020
Strasbourg, France

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The EDQM announces the availability of:

6 new European Pharmacopoeia (Ph. Eur.) reference standards:

Catalogue code

NAME

Unit quantity PRICE

Y0002219

Fluoxetine hydrochloride for ID and assay CRS

250 mg

79 EUR

Y0002208

Epinastine for system suitability A CRS

10 mg

79 EUR

Y0002243

Latanoprost - reference spectrum

N/A

79 EUR

Y0002218

Latanoprost CRS

100 mg

1000 EUR

Y0002206

Bambuterol impurity mixture CRS

0.002 mg

79 EUR

Y0002195

Deferasirox impurity F CRS

20 mg

79 EUR

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20 replacement batches for Ph. Eur. reference standards:

Catalogue code

Name

Batch

Unit quantity

Price

Y0001112

Gestodene CRS

3

130 mg

79 EUR

T0014000

Tamoxifen citrate CRS

3

80 mg

79 EUR

L0399900

Levocarnitine CRS

4

125 mg

79 EUR

Y0001288

Salbutamol sulfate for system suitability CRS

4

0.4 mg

79 EUR

Y0001269

Aciclovir for peak identification 2 CRS

6

0.004 mg

79 EUR

I0320330

Interferon gamma-1b CRS

3

0.5 mL

90 EUR

Y0002027

Zoledronic acid impurity B CRS

2

15 mg

79 EUR

Y0001282

Heparin for physico-chemical analysis CRS

3

300 mg

79 EUR

Y0000441

Didanosine impurity A CRS

2

20 mg

79 EUR

P2700000

Prednisolone CRS

10

110 mg

79 EUR

F0189000

Flumequine CRS

2

60 mg

79 EUR

A0150000

Acetylcysteine CRS

4

50 mg

79 EUR

R0250000

Class 1 residual solvent solution CRS

8

1.4 mL

79 EUR

Y0000218

Ondansetron hydrochloride dihydrate CRS

5

220 mg

79 EUR

Y0001408

Prilocaine impurity B CRS

2

80 mg

79 EUR

Y0000764

Fluorouracil impurity C CRS

2

20 mg

79 EUR

Y0000813

Bisoprolol for system suitability CRS

5

1.003 mg

79 EUR

Y0001334

Clopidogrel for system suitability CRS

3

70 mg

79 EUR

Y0000630

Paroxetine for system suitability CRS

2

0.02 mg

79 EUR

Y0000597

Spectinomycin hydrochloride CRS

3

100 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 1 July 2020) 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).

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 will be 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).

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Information on change of sales units

None.

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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.

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Information on change of EDQM storage/shipping conditions

None.

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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. 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.

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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, on your company letterhead, states both the catalogue code and substance name)

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