1.0 OBJECTIVE :
To design a Standard Operating Procedure that describes the procedure for preparation of Hydro-alcohol extract of plant material/formulation.
2.0 SCOPE:
This SOP shall be applicable to the Department of Chemistry. This SOP also applies to the extraction of all types of plant material, including leaves, flowers, stems, roots, and seeds. It also applies to the extraction of all types of formulations, including oils, tinctures, and extracts.
3.0 RESPONSIBILITY:
The following personnel are responsible for the implementation of this SOP:
The Quality Assurance Manager is responsible for the overall quality of the extraction process.
The Production Manager is responsible for the day-to-day operation of the extraction process.
The Laboratory Technician is responsible for the preparation of the plant material and the selection of the extraction solvent.
The Extraction Operator is responsible for the extraction process itself.
The Production Manager is responsible for the day-to-day operation of the extraction process.
The Laboratory Technician is responsible for the preparation of the plant material and the selection of the extraction solvent.
The Extraction Operator is responsible for the extraction process itself.
4.0 INTRODUCTION:
The solid extract is obtained by extracting the raw material/formulation with hydro-alcohol, followed by the evaporation of the solvent under reduced pressure.
5.0 PROCEDURE:
The solid extract is obtained by extracting the raw material/formulation with hydro-alcohol, followed by the evaporation of the solvent under reduced pressure.
5.0 PROCEDURE:
Prepare the plant material. The plant material should be washed thoroughly with water to remove any dirt or debris. It should then be dried in a clean, well-ventilated area.
Select the extraction solvent. The extraction solvent should be selected based on the type of plant material and the desired end product. For example, water is a good solvent for water-soluble compounds, while ethanol is a good solvent for fat-soluble compounds.
Extract the plant material. The extraction can be carried out using a variety of methods, including Soxhlet extraction: The plant material is placed in a thimble and suspended in a flask containing the extraction solvent. The flask is then heated, and the solvent is repeatedly boiled and condensed, passing through the thimble and extracting the plant material.
Maceration: The plant material is placed in a jar with the extraction solvent and allowed to soak for a period of time. The solvent is then filtered to remove the plant material.
Supercritical fluid extraction: A supercritical fluid, such as carbon dioxide, is used to extract the plant material. The supercritical fluid is then depressurized, and the extracted compounds are collected.
Concentrate on the extract. The extract can be concentrated by evaporation, distillation, or freeze-drying.
Store the extract. The extract should be stored in a cool, dark place.
6.0 PRECAUTIONS:
· Loss of solvent should be avoided.
· Weighing of the dried sample and extract should be done accurately and properly.
7.0 QUALITY ASSURANCE:
The quality of the extraction process should be monitored by the Quality Assurance Manager. The following tests should be conducted to ensure the quality of the extract:
Identity test: The identity of the extract should be confirmed by comparing its physical and chemical properties to those of a known reference standard.
Purity test: The purity of the extract should be determined by measuring the concentration of the active compounds.
Stability test: The stability of the extract should be determined by storing it under a variety of conditions and measuring its potency over time.
8.0 REFERENCES:
[In-house method].
9.0 ABBREVIATIONS: NA
10.0 DEFINATIONS: NA
11.0 DOCUMENTATION:
The following documentation should be maintained for each extraction:
A logbook should be maintained that records the date, time, and type of extraction.
A sample of the extract should be retained for future reference.
12.0 RECORDS
The following records should be maintained for each extraction:
A copy of the SOP should be maintained.
The results of the quality assurance tests should be maintained.
The documentation of the extraction process should be maintained.
A sample of the extract should be retained for future reference.
12.0 RECORDS
The following records should be maintained for each extraction:
A copy of the SOP should be maintained.
The results of the quality assurance tests should be maintained.
The documentation of the extraction process should be maintained.
END OF THE DOCUMENT
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