SC VIII Materials for use in the Manufacture of Homoeopathic Preparations

This Supplementary Chapter provides information on Materials for use in the Manufacture of Homoeopathic Preparations.

Introduction

This Supplementary Chapter provides information to help the users of the British Pharmacopoeia gain a greater understanding of the process for elaborating monographs for materials for use in the manufacture of homoeopathic preparations.

Homoeopathic Medicinal Products are classed as medicines under Article 13 of EU Directive 2001/83/EC, as amended by Directive 2004/27/EC. The Directive defines a Homoeopathic Medicinal Product as ‘any medicinal product prepared from substances called homeopathic stocks in accordance with a manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contain a number of principles.’. As stated in the British Pharmacopoeia Supplementary Chapter III B concerning the circumstances for selecting materials for monograph development, the British Pharmacopoeia Commission’s policy is to support relevant EC directives; this in particular relates to Directive 2001/83/EC, as amended.

The publication of British Pharmacopoeia monographs for materials for use in the manufacture of homoeopathic preparations is intended to provide official, objective and publicly available standards of quality. It is emphasised that, although the monographs provide standards for quality, it is not the role of the British Pharmacopoeia Commission to assess the safety or efficacy of these materials.

To date, preparation of monographs for materials for use in the manufacture of homoeopathic preparations has been based on monographs present in the British Homoeopathic Pharmacopoeia and have been prioritised in accordance with the availability of these materials within the United Kingdom.

The ultimate aim is to ensure that the quality of the monographs for the herbal materials and chemicals for homoeopathic use are of an equivalent standard to those of established monographs for herbal drugs and chemicals.

Authenticated herbal samples should be used for the development of monographs for materials for use in the manufacture of homoeopathic preparations. When a plant species that is not part of the definition in the monograph is known to be a substituent or adulterant, an absence or limit test is included in the monograph where possible.

Monograph Titles

For materials for use in the manufacture of homoeopathic preparations, the title, including any subsidiary titles, includes ‘… for Homoeopathic Preparations’. The main title of a monograph for a chemical is the English name; the Latin name, where appropriate, is given as the subsidiary title.

Control Methods

In cases where the bulk starting material and any excipients for dilution or trituration are covered by a BP or Ph Eur monograph, the material and/or excipient must comply with the relevant pharmacopoeial monograph. If the material is not covered by an existing BP or Ph Eur monograph, tests to check the quality of the starting material are included in the specific monograph for homoeopathic materials.

Characteristics References to odour are only included where this is highly characteristic. References to taste are not included.

Identification: (a) Herbal drugs Reliance for identification of herbal homoeopathic materials is primarily placed on the macroscopical description. In addition, a microscopical description and thin-layer chromatographic test may be included to strengthen the identification.

The macroscopical description includes those features that can be seen by the unaided eye or by the use of a hand lens.

The microscopical description of the powdered herbal drug gives information on the diagnostic characters.

(b) Chemicals Tests such as specific colour reactions are included unless the raw material is already controlled within the British Pharmacopoeia.

Tests The following tests are applied, where applicable, in addition to the tests or requirements given in the monographs for Homoeopathic Preparations, Herbal Drugs for Homoeopathic Preparations and Mother Tinctures for Homoeopathic Preparations:

Monographs for mother tinctures The control of the herbal drug is followed by a separate section entitled ‘Mother Tincture’ that states the method of production followed by the relevant control tests.

Monographs for chemical stocks The format and layout is similar to that for mother tinctures above, whereby the control of the chemical is followed by a separate heading section entitled ‘Production of Stock’ that states the method of production followed by the relevant control tests.

Production A cross-reference is made to the method of manufacture given in the monograph entitled Methods of Preparation of Homoeopathic Stocks and Potentisation. If the method is not included, a general statement relating to a suitable method is included in the specific monograph. When a British Pharmacopoeia or European Pharmacopoeia monograph exists for a vehicle or excipient, that vehicle or excipient complies with the monograph.

Tests Identification tests are included for the mother tincture or chemical stocks; vehicles and/or excipients used are also identified. No testing is given for subsequent dilutions or triturations owing to the difficulty in applying analytical methodology to high dilutions. In the case of mother tinctures thin-layer chromatography is usually specified for the identification.

Assay When an assay is given for the bulk material, it is also applied to the relevant mother tincture or chemical stock. Where necessary, the method includes a means of overcoming interference from excipients.