Submitting a Monograph

Exemplarum Monographium

(1)  Official Monograph Name – The name that has been used traditionally in homeopathic literature. General rules:

Botanical and Zoological products – Usually the scientific name; in some cases, the Latin name of the derived substance from the plant or animal (e.g. Stigmata Maidis), or the name in commerce, with or without a Latin ending (e.g. Balsamum Peruvianum). May also include the Latin name for the plant part (e.g. Flos, Radix, Oleum) or a Latin adjective (e.g. Cruda, Purum, Tosta).

Chemical elements and compounds – Usually the Latin name of the substance, or the name used in commerce, with or without a Latin ending. May include a Latin adjective (e.g. Album, Metallicum).

Chemical mixtures, minerals spring waters – Usually the common name (e.g. Gunpowder, Slag, Jasper), but occasionally the Latin name is used.

Nosodes – Usually the Latin name of the pathogen or causative agent (e.g. Proteus, Vaccinotoxinum) or the medical name of the disease with a Latin ending (e.g. Anthracinum, Pertussinum).

---

Name in Contemporary Use

(5)  For botanical and zoological products, the contemporary name is either the current scientific name of the plant or animal, including the abbreviation of the author of the name; or a common name in current use. For chemicals, minerals, nosodes and spring waters, the contemporary name is a common name in current use.

Sample Monograph Format

Synonyms

(6)   Other names for the product, either archaic or in contemporary use. Can be helpful when sourcing materials from other locales.

Biological Classification

(7)  The taxonomic classification of a biological substance. Usually only the family is specified, but in some cases the order, class, and/or phylum might also be specified.

Chemical Formula And Molecular Weight

(7)  The formula and atomic or molecular weight of a chemical element or compound. When chemical substances contain water of hydration, the molecular weight is of the anhydrous form; a hydrated weight can also be provided.

ABe₂Ce₃  M.W. 999.999 

Description

(8)  Description of the physical characteristics of the starting material and/or the finished product, including unique properties by which it can be identified.

May include instructions for making the starting material from appropriate raw materials.

A thing characteristic of its kind or illustrating a general rule. An illustration or sample of a type or pattern.  A sample, utilizing made up bits of data, to provide a guide regarding the various parts of a typical monograph as a help to those subscribing to the HPUS, or those wishing to submit a monograph to the HPCUS; submissions must include the requisite data in the correct format.

Range And Habitat

(9)  Description of the geographic area and physical habitat in which a botanical or zoological substance occurs, as well as specific information concerning its collection. For naturally occurring minerals, if the geographic areas are unique or unusual, these are described.

Limited to a single special webpage of the world wide web.

Preparation And Classification

(10)  Description of the homeopathic preparation made from the starting material, including the specific HPUS class (see Guidelines for Manufacturing Homeopathic Medicines) according to which the product should be manufactured. Both liquid and solid classes are specified where appropriate.

Solution of the example (Class A). 

Trituration of the example (Class F).

Lowest Permissible Attenuation

(11)  The initial homeopathic attenuation to be safely marketed and labeled as OTC, Topical Use, or Rx-only.

(12)  See the Explanation of the Attenuation Levels recognized by the HPCUS  for more information.

Labeling Statements 

(13)  Monograph-specific information that must be included in product labeling as required by 21 CR 369.7

Labeling of this monograph product must clearly state the nature of its use as an educational example tool, and that it is not to be utilized for therapeutic purposes.

Monograph Note 

(14)  Additional monograph-specific information included to help prevent product mix-ups, sourcing or testing problems.

Because of the specific use of this monograph as an aid to understanding the layout of HPUS monographs, the information contained herein is not intended to be utilized as the basis for an actual homeopathic drug product. Caution is urged so as not to be confused by the purpose of the text herein and to accept the tongue-in-cheek nature of data while using it as an educational example tool. 

Quality Control Specifications

(15)  Test methods and acceptance criteria.  See also Clarification: QC Test Validation,  and the Introduction to the Standard & Controls Reagents & Test Methods

[Standards & Controls Specifications is a draft standard open for public comment for a period of 1.5 years from the Standards & Controls revision date on this monograph. After this comment period, this Standards & Controls data will become official.]

Starting Material

(17)  Identification and other tests as appropriate for the Starting Material from which the homeopathic product is made.  When necessary, assays are also included.

A. Macroscopic identification: To comply with monograph Description.

B. Additional tests:

Test 1:

Flesch-Kincaid Grade Level: not less than 7.0 and not more than 8.0.

Test 2:

Flesch Reading Ease: not less than 60 and not more than 70.

Tincture

(18)  Separate test section for Tinctures (usually of botanical origin).

(all quality control data is applicable to macerate tinctures only)

1. CHARACTERISTICS

(19)  Organoleptic tests

A. Color: black and white

B. Odor: representative (only included if both characteristic and easily identifiable)

2. IDENTIFICATION

(20) Identification and other tests (as appropriate) of the tincture.  May include multiple sets of tests, not all of which are required; see the information in the criteria.

Criteria for identification; tincture must meet the following identification test:

                                 Test 1 or Test 2

Test 1 Descriptive Content:

Test method described in detail (or reference to commonly available literature containing test method) along with acceptable test results. All reagents are defined and/or explained in the Standard & Controls Reagents & Test Methods.

Test 2 Explanatory Detail: Method for determining results given with sufficient clarity so can be performed by laboratory personnel with usual training. Any reagents to be used are clearly identified in the Standard & Controls Reagents & Test Methods.

3. ALCOHOL CONTENT

(21)  Quality Tests for Tinctures (usually of botanical origin).

65% v/v (±15%) as per S & C Section – Alcohol Determination.

4. DRY RESIDUE

not less than 1.0%, as per S & C Section – Dry Residue Determination.

5.  ASSAY

(22)  Assay for safety and/or quality parameters.

The tincture contains not less than 90.0% explanatory content to aid in understanding the format and content of official monographs.

Assay method described along with method for determining numeric result for comparison with above acceptance criteria.

Publication date of current version