|
English name: Land-caltrops,
Puncture-vine
Sanskrit name:
Gokshura
Family: Zygophyllaceae
Part used:
Fruit
| Extraction
method: |
CO2
extracts | Solvent extracts
Fortified extracts | Whole herb extracts |
More
info |
 Traditional
uses: Diuretic, tonic, cooling, aphrodisiac and
the dried fruits are used in cases of spermatorrhoea,
phosphaturia, diseases of genito-urinary tract such
as dysuria, gonorrhoea, chronic cystitis, calculous
affections, urinary disorders, incontinence of urine,
gout and impotence also in uterine disorders after parturition.
The seeds are strengthening and the ash of plant is
good for external application in rheumarthritis.
Phytochemistry:
The major bioactive constituents of Tribulus terrestris
are “steroidal saponins” mainly spirostanol
type viz. tribulosin, dioscin, desgalactotigonin, F-gitonin,
terrestrosins A-E etc. The drug also contains
furostanol type saponins viz. terrestrosins F-K and
others. Other constituents include alkaloids,
lignanamides and flavonoids.
Pharmacology:
Tribulus terrestris has been extensively evaluated for
various pharmacological activities. Tribulus terrestris
is found to be potent diuretic, nephroprotective and
antiurolithiatic. It also has been reported for
its anti anginal hepatoprotective and anthelmintic activity.
Marker constituents: Tribulosin,
Saponins.
Main uses: Aphrodisiac, Diuretic, Anti-urolithiatic.
Specification: 20%
| SL NO |
TESTS |
LIMITS |
PROTOCOL |
| 1. |
Description |
Brown to dark brown hygroscopic
powder. |
| 2. |
Physico-chemical analysis
|
|
|
| Moisture (%w/w) |
< 15.0 |
As per USP <921> Method II |
Ash content (%w/w)
|
< 30.0 |
As per USP<561> |
| Acid insoluble ash (%w/w) |
< 3.5 |
| 3. |
Particle Size |
|
|
Bulk Density (g/cc)
|
0.20 – 0.60 |
As per USP <616> Method - I |
| Tapped bulk density |
0.20 – 0.80 |
| Material passing through 30# BS/35 ASTM (%w/w) |
> 99.0 |
As per USP <786> Particle Size distribution. |
| 4. |
Heavy metal analysis |
|
AAS / ICP –ES |
| Lead |
< 10 ppm |
| Cadmium |
< 1 ppm |
| Arsenic |
< 2ppm |
| 5. |
Microbiological analysis |
|
As per WHO/PHARMA/92.559/Rev.1 Pg.49-52 |
| As per FIP Guidelines |
|
| Total Viable Aerobic Count |
< 104 cfu g-1 |
| Total Enterobacteriaceae |
< 102 org g-1 |
| Total Fungal Count |
< 102 fs g-1 |
| 6. |
Test for Specific Pathogen |
|
| As per FIP Guidelines |
|
| E.coli (1g) |
Absent |
| Salmonella Sp. (10g) |
Absent |
| S.aureus (1g) |
Absent |
| 7. |
Mycotoxin analysis |
<5ppb |
As per USP Test for Aflatoxins |
| Aflatoxins (B1 + B2 + G1 + G2) |
| 8. |
Residual solvent analysis |
<3000 ppm |
As per USP <467> |
| As per ICH Guidelines |
| Methanol |
| 9. |
Pesticide residue analysis |
To comply with
USP |
As per AOAC / USP. |
| As per USP & BP Limits |
| Organochlorine Pesticides |
| Organophosphorus Pesticides |
| Synthetic pyrethroids |
| 10. |
Phytochemical analysis |
>= 20.0 |
By Gravimetry |
| Total Saponins (%w/w) |
Specification: 40% Total
Saponins
| SL NO |
TESTS |
LIMITS |
PROTOCOL |
| 1. |
Description |
Brown to dark brown hygroscopic
powder. |
| 2. |
Physico-chemical analysis
|
|
|
| Moisture (%w/w) |
< 15.0 |
As per USP <921> Method II |
Ash content (%w/w)
|
< 30.0 |
As per USP<561> |
| Acid insoluble ash (%w/w) |
< 3.5 |
| 3. |
Particle Size |
|
|
Bulk Density (g/cc)
|
0.20 – 0.60 |
As per USP <616> Method - I |
| Tapped bulk density |
0.20 – 0.80 |
| Material passing through 30# BS/35 ASTM (%w/w) |
> 99.0 |
As per USP <786> Particle Size distribution. |
| 4. |
Heavy metal analysis |
|
AAS / ICP –ES |
| Lead |
< 10 ppm |
| Cadmium |
< 1 ppm |
| Arsenic |
< 2ppm |
| 5. |
Microbiological analysis |
|
As per WHO/PHARMA/92.559/Rev.1 Pg.49-52 |
| As per FIP Guidelines |
|
| Total Viable Aerobic Count |
< 104 cfu g-1 |
| Total Enterobacteriaceae |
< 102 org g-1 |
| Total Fungal Count |
< 102 fs g-1 |
| 6. |
Test for Specific Pathogen |
|
| As per FIP Guidelines |
|
| E.coli (1g) |
Absent |
| Salmonella Sp. (10g) |
Absent |
| S.aureus (1g) |
Absent |
| 7. |
Mycotoxin analysis |
<5ppb |
As per USP Test for Aflatoxins |
| Aflatoxins (B1 + B2 + G1 + G2) |
| 8. |
Residual solvent analysis |
<3000 ppm |
As per USP <467> |
| As per ICH Guidelines |
| Methanol |
| 9. |
Pesticide residue analysis |
To comply with
USP |
As per AOAC / USP. |
| As per USP & BP Limits |
| Organochlorine Pesticides |
| Organophosphorus Pesticides |
| Synthetic pyrethroids |
| 10. |
Phytochemical analysis |
>= 40.0 |
By Gravimetry |
| Total Saponins (%w/w) |
Specification: 55% Total Saponins
| SL NO |
TESTS |
LIMITS |
PROTOCOL |
| 1. |
Description |
Brown to dark brown hygroscopic
powder. |
| 2. |
Physico-chemical analysis
|
|
|
| Moisture (%w/w) |
< 15.0 |
As per USP <921> Method II |
Ash content (%w/w)
|
< 30.0 |
As per USP<561> |
| Acid insoluble ash (%w/w) |
< 3.5 |
| 3. |
Particle Size |
|
|
Bulk Density (g/cc)
|
0.20 – 0.60 |
As per USP <616> Method - I |
| Tapped bulk density |
0.20 – 0.80 |
| Material passing through 30# BS/35 ASTM (%w/w) |
> 99.0 |
As per USP <786> Particle Size distribution. |
| 4. |
Heavy metal analysis |
|
AAS / ICP –ES |
| Lead |
< 10 ppm |
| Cadmium |
< 1 ppm |
| Arsenic |
< 2ppm |
| 5. |
Microbiological analysis |
|
As per WHO/PHARMA/92.559/Rev.1 Pg.49-52 |
| As per FIP Guidelines |
|
| Total Viable Aerobic Count |
< 104 cfu g-1 |
| Total Enterobacteriaceae |
< 102 org g-1 |
| Total Fungal Count |
< 102 fs g-1 |
| 6. |
Test for Specific Pathogen |
|
| As per FIP Guidelines |
|
| E.coli (1g) |
Absent |
| Salmonella Sp. (10g) |
Absent |
| S.aureus (1g) |
Absent |
| 7. |
Mycotoxin analysis |
<5ppb |
As per USP Test for Aflatoxins |
| Aflatoxins (B1 + B2 + G1 + G2) |
| 8. |
Residual solvent analysis |
<3000 ppm |
As per USP <467> |
| As per ICH Guidelines |
| Methanol |
| 9. |
Pesticide residue analysis |
To comply with
USP |
As per AOAC / USP. |
| As per USP & BP Limits |
| Organochlorine Pesticides |
| Organophosphorus Pesticides |
| Synthetic pyrethroids |
| 10. |
Phytochemical analysis |
>= 55.0 |
By Gravimetry |
| Total Saponins (%w/w) |
Note:
Residual solvent analysis and residual pesticide analysis
are performed only on request.
|
