Parenteral Preparations of the British Pharmacopoeia

In addition to the above requirements of the European Pharmacopoeia, the following statements apply to any injection, intravenous infusion or implant that is the subject of an individual monograph in the British Pharmacopoeia.

Definition of a particular Parenteral Preparation as a solution, emulsion or suspension in Water for Injections does not preclude the inclusion of suitable excipients where necessary for the purposes referred to in the requirements of the European Pharmacopoeia above. In particular, aqueous Parenteral Preparations for administration by the subcutaneous, intradermal, intramuscular, or, in the case of larger volumes, intravenous route, should if possible be made isotonic with blood by the addition of Sodium Chloride or other suitable substances. However if buffering agents are used in preparations intended for intra-ocular or intracardiac injection, or in preparations that may gain access to the cerebrospinal fluid, great care should be taken to ensure that the nature and concentration of the chosen agent are suitable for the intended route of administration.

Where the active ingredient is susceptible to oxidative degradation appropriate precautions, such as the addition of a suitable antioxidant or storage under oxygen-free nitrogen or other suitable inert gas, should be taken.

Methods of sterilisation that may be used in the manufacture of Parenteral Preparations are described in Appendix XVIII.

Where a direction is given to use Water for Injections in the manufacture of a Parenteral Preparation, Water for Injections in bulk is used. Where the use of Water for Injections free from dissolved air or Water for Injections free from dissolved carbon dioxide is specified, water freshly prepared by the process described under Water for Injections is boiled for at least 10  minutes with as little exposure to air as possible, cooled with precautions to exclude air and carbon dioxide, and sterilised by heating in an autoclave.

Closures used for containers of oily parenteral preparations should be made of oil-resistant materials.

Where appropriate the label states the strength of the parenteral preparation in terms of the amount of active ingredient in a suitable dose-volume.

The label also states (1) the name of any added substance; (2) the date after which the Parenteral Preparation is not intended to be used; (3) the conditions under which the Parenteral Preparation should be stored.

The label of a single-dose parenteral preparation states that any portion of the contents remaining should be discarded.

The label states the nominal volume of the contents.

When required for the Assay of a powder for injection, determine the weight of the contents of 10 containers as described in the test for uniformity of weight, Appendix XII C1.

The label states (1) that, when dissolved or suspended, the contents of the sealed container are intended for parenteral use; (2) the amount of active ingredient contained in the sealed container; (3) the directions for the preparation of the Injection or Intravenous Infusion.

If a container of the liquid for constituting the parenteral preparation is supplied with the powder for injections, the label of this container states the composition of this liquid.

The label states (1) the name of the concentrated solution; (2) that the solution must be diluted before use; (3) the directions for the preparation of the Injection or Intravenous Infusion.