The British Pharmacopoeia Website
Medicines and Healthcare products Regulatory Agency
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Information

Intended Use

BPCRS are supplied solely for use in the tests and assays of the British Pharmacopoeia or British Pharmacopoeia (Veterinary) in which a BPCRS is required. They are issued only for chemical analysis and may not be suitable for any other purposes. They are not intended for administration to humans or animals. BPCRS are supplied in unit packs containing sufficient material to carry out the prescribed procedures.

Storage and Shipping

Customers are advised to order only as required, particularly where a BPCRS is to be used for a quantitative test. Although Reference Substances are of the required quality when despatched, there is a risk of deterioration on storage.

BPCRS should be kept under the conditions stated in the appropriate monograph of the British Pharmacopoeia or British Pharmacopoeia (Veterinary). 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 8°C.

Where the long term storage requirement is at ambient (below 25°C) or refrigerator (between 2°C and 8°C), BPCRS are usually shipped at ambient temperature for the short shipping time.  Items should be placed in the long term storage conditions as described on receipt.  Where the long term storage requirement is in a freezer (-20°C), BPCRS are shipped under cold-packs to maintain integrity of the materials.  Such items are only shipped on certain days, to avoid weekend transit delays.  Items should be placed in the long term storage conditions as described on receipt.

Controlled Drugs

Controlled Drugs (narcotics) and Drug Precursors (category 1 substances) are subject to import and export control restrictions. It is the responsibility of the customer to obtain necessary licences and other relevant documentation to comply with the laws of the importing country.

Schedule 1 to 5 Controlled Drugs (narcotics):

Category 1 Substances (precursor chemicals):

For all applications, the name and address of the Exporter must be as follows:
British Pharmacopoeia Commission Laboratory, Queens Road, Teddington, Middlesex TW11 0LY

A PDF version of the customer declaration for Category 1 Substances is available here (opens new window).  A copy of this should be completed and signed by a Senior Official who is authorised to possess and handle Category 1 substances and included with the order.

Leaflets

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

Expiry Dates

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 its 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. All BPCRS are supplied with a shelf life of 3 months from the date of despatch to allow customers to use BPCRS after they have been replaced by a new batch. The current batch number (Batch No.) is always listed on the website.

Terms of Trade

The following Terms of Trade links are to PDF documents and open in a new window.