Frequently Asked Questions

CAN I USE THE BPCRS FOR A METHOD THAT IS NOT THE SAME AS THE MONOGRAPH METHOD?

BPCRS are intended only for use in the tests and assays of the BP or BP (Vet) in which they are required and may not be suitable for any other use. The declared content figures are calculated using the prescribed methods. If the BPCRS is to be used for a method other that the one prescribed in the BP, then it is the responsibility of the analyst to ensure that the BPCRS is suitable for this other use.

IF NO DECLARED CONTENT FIGURE IS PROVIDED, CAN I ASSUME THAT THE CONTENT IS 100%?

No! A declared content is not given if the standard is not used for assay purposes. However, this does not mean that the substance is 100% pure.

WHAT IS THE "CURRENT LOT" SYSTEM?

In order to minimise the number of changes in batch number, the "Current Lot" system is used. When a substance is released for use as a BPCRS this substance is retested regularly to confirm it's continued suitability for use. No expiry date is given and the substance is replaced only when exhausted (or in rare cases when it is no longer suitable for use). This system reduces the number batches replaced due to expiry and helps to reduce the costs of producing BPCRS.

WHAT IS THE EXPIRY DATE OF MY BPCRS?

BPCRS are supplied with a shelf life of three months from the date of despatch. The current lot is always valid for use when supplied and Customers are advised to order only as required.

HOW SHOULD I STORE MY BPCRS BEFORE USE?

BPCRS should be kept under the conditions stated in the appropriate monograph of the BP or BP (Vet). All BPCRS should be stored in well-closed containers and it is recommended that they are stored below 25°C. A BPCRS used for assay purposes should be stored between 2°C and 10°C.

BPCRS should not be kept for longer than 3 months from the date of despatch, as after this time the quality of the BPCRS is not guaranteed.

CAN I STORE MY BPCRS AFTER OPENING AND USE AGAIN AT A LATER DATE?

This is not advised. BPCRS are supplied in single use packs containing sufficient quantities to perform the tests prescribed in the monograph.

If the BPCRS is used for quantitative analysis, then it should be discarded after use. If the BPCRS is not for quantitative use (for example a resolution test mixture) then it may be possible to store the BPCRS as a solid or in solution and use again at a later date. In this situation, the analyst should satisfy himself or herself that the BPCRS is still suitable for use after storage.

HOW CAN I FIND OUT THE DECLARED CONTENT OF MY BPCRS?

You should have received a leaflet with the BPCRS stating the current lot and the declared content figure. The current lot and declared content are also stated in the website catalogue.

WHAT IS THE POTENCY OF MY BPCRS?

You should have received a leaflet with the BPCRS stating the current lot and the declared content ("potency") figure. The current lot and declared content are also stated in the website catalogue.

WHAT IS THE PURITY OF MY BPCRS?

You should have received a leaflet with the BPCRS stating the current lot and the declared content ("purity") figure. The current lot and declared content are also stated in the website catalogue.

WHAT INFORMATION WILL I RECEIVE WITH MY BPCRS?

Leaflets, which accompany the BPCRS, contain important information regarding analytical data, storage conditions and advice on safe handling where necessary. Certificates of analysis (C of A's) are not supplied. Declared content figures are supplied where required.

WILL I RECEIVE A CERTIFICATE OF ANALYSIS?

No. All BPCRS are supplied with sufficient information to perform the intended test(s). Certificates of analysis are not supplied. Declared content figures are supplied where required.

WHAT IS THE CUSTOMS TARIFF CODE FOR BPCRS?

All BPCRS are covered by the customs tariff code 3822.00.00.00 "Reference Material for Laboratory Use".

ARE BPCRS DANGEROUS IN TRANSIT?

No. BPCRS are supplied in small quantities, usually less than 0.1 g and are not dangerous in transit. One BPCRS is covered by the UN Dangerous Goods List:

• CAT 652 Glyceryl Trinitrate solution (1%): Class 3, UN No 1204.

I WOULD LIKE TO ORDER A CONTROLLED DRUG. WHAT DOCUMENTATION DO I NEED?

It is your responsibility to obtain any licences or other relevant documentation to comply with the laws of the importing country.

Schedule 1 to 5 Controlled Drugs (narcotics):

For UK customers, a copy of the customers "Licence to Possess and Supply" must be provided.

For overseas customers, a valid Import Licence must be provided, detailing the name and address of the Exporter, the name and address of the Importer and the quantity of the controlled substance(s) required.

Category 1 Substances (precursor chemicals):

For European Union customers, a "Declaration of Specific Use" must be provided, detailing the name, address and Authorisation/Licence/Registration number of the End User, the name and address of the Supplier, the quantity of the controlled substance(s) required and what the substance will be used for.

For customers outside the EU, a "Declaration of Specific Use" as above and a valid Import Licence detailing the name and address of the Exporter, the name and address of the Importer and the quantity of the Category 1 substance(s) required must be provided.

For all applications, the name and address of the Exporter must be as follows:

• BP Commission Laboratory, Queens Road, Teddington, Middlesex TW11 0LY

WHO SHOULD I MAKE MY CHEQUE PAYABLE TO?

All cheques MUST be made payable to MHRA.

We regret that we cannot accept cheques payable to any other name and these will be returned to you.

THERE IS A REFERENCE STANDARD MENTIONED IN A BP MONOGRAPH BUT I CAN'T FIND IT IN THE BPCRS CATALOGUE. WHERE CAN I BUY THIS STANDARD?

If the reference standard is followed by the letters CRS, then it is a European Pharmacopoeia standard and should be ordered from the European Pharmacopoeia (website www.pheur.org; email crs@pheur.org).

Only those standards which are followed by the letters BPCRS are available from the BP Laboratory.