The document discusses the testing protocol for active pharmaceutical raw materials in herbal drugs, emphasizing the importance of pharmacognostic analysis to verify the identity, purity, and quality of herbal drugs. It details various methodologies for qualitative and quantitative testing, including macroscopic and microscopic examinations, chemical analyses through chromatography, and checks for contaminants like heavy metals and pesticides. Specific limits for heavy metals and methodologies for assessing foreign matter are also highlighted.

1. Test for active pharmaceutical raw materials
in herbal drugs

2. Introduction
The term “herbal drugs” denotes plants or plant parts
that have been converted into phytopharmaceuticals
by means of simple processes involving harvesting,
drying, and storage.

3. Pharmacognostic analysis
Qualitative and quantitative tests in order to verify or to establish the
drugs -
Identity
Purity
Quality

4. Parameters
Identity parameters:
Qualitative chemical analysis:
Chromatographic analysis
Purity parameters:
Foreign matter.
macroscopic examination
microscopic examination

5. CONTD..
• Quality parameters: loss on drying; soluble-substances; total
ash and ash insoluble in hydrochloric acid; heavy metals; assay
of active principles;
• Microbiological examination (bacteria, yeasts and moulds,
specified microorganisms);
• Pesticide residues; aflatoxins; ochratoxins.

6. Macroscopic examination
Methodology
• Morphological characters and the colour may be examination with
the naked eye or by using a magnifying glass.
• The size can be determined by using a ruler or a caliper.
• The odour can be determined by shattering the drug between two
fingers and smell, or using an extractive solution.
• The taste can be determined by putting a piece of drug or an
extractive solution in the mouth.
Determination of morphological characters

7. Microscopic examination
It is carried out on the powdered drug.
common reagent:
Other reagents are:
Determination of the anatomic characteristics
Lactic reagent
Ruthenium red solution
Glycerol
Chloral hydrate

8. Evaluation of results
Phloroglucinol is used to identify
the presence of lignin.
Ruthenium red solution is used to
show the presence of mucilage.
Glycerol is used to show the
presence of starch and inulin.

9. Qualitative chemical analysis
Evaluation of results
Confirm the presence of a chemical compound

10. Qualitative chromatography
Techniques:
TLC: Each compound has a characteristic spot, with a definite Rf-value,
colour and / or fluorescence.
Gc & hplc: this technique is used both for identification and for assay.
TLC
HPLCGC

11. Foreign matter
Methodology
• A macroscopic examination, microscopic examination, reactions or
chromatography are used to identify foreign matters.
Evaluation of results
• All results are compared with pure herbal drugs.
• The content of foreign matter is expressed as %.
Limits:
• Not more than 2%

12. Heavy metals
Methodology
Atomic absorption spectrometry (AAS).
Limits
• cadmium – max. 1.0 ppm
• lead – max. 5.0 ppm
• mercury – max. 0.1 ppm.
Express the pollution

13. Thank You