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Training Modules and Guidelines


(PROTOCOL – I)

Standardization of Single Plant Material
 (Raw Drug)

 

S.No.

Test

1.

Botanical Description

Sanskrit Synonyms/Regional name
Part Used

Botanical Origin

Distribution

Adulteration

substitution

Season of Collection

Site of collection

Stage of plant

Substitution of exhausted products/Foreign matter

2.

Description

Colour

Odour

Taste

Fracture/ texture

3.

Identification

Macroscopy

Microscopy

Colour test

Chemical test

TLC/HPTLC etc.

4.

Physico-chemical Parameters

Loss on drying at 105 oC

Total- ash

Acid insoluble ash

Total solid

Alcohol soluble extractive

Water soluble extractive

pH

Volatile oil

5.

Assay for Constituents (Marker % , Major compounds like Alkaloids,flavonoids/saponin compounds

6.

Particle size

Bulk density

Tap density

7.

Test for heavy/toxic metals

As per WHO / FDA (Permissible limit)

Lead

10.0 ppm

Cadmium

0.30 ppm

Mercury

1.00 ppm

Arsenic

10.0 ppm

8.

Microbial contamination   (See Annexure-2)

Total viable aerobic count

Total Enterobacteriaceae

Total fungal count

9.

Test for specific pathogen (See Annexure-2)

E. coli

Salmonella spp.

S. aureus

Pseudomonas aeruginosa

10.

Pesticide residue (See Annexure-1)

Organochlorinepesticides

  1. DDT( all derivatives)
  2. HCH( all their Isomers)
  3. Endosufan
  4. Alderin used as standard

Organophosphorus pesticides

  1. Malathion
  2. Parathion

Pyrethroids

11.

Test for aflatoxine (B1,B2,G1,G2)

12.

Safety Profile 

13.

Shelf life

14.

Other Requirements

Packing and labeling

ASU Formulation in which used

Therapeutic Applications

15.

Dose and manner of Administration

 


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