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English name: Olibanum,
Frankincense
Sanskrit name:
Sallaki
Family: Burseraceae
Part used: Gum
Extraction
method: |
CO2
extracts | Fortified extracts
Solvent extracts | Whole herb extracts |
More
info |
 Traditional
uses: The gum is credited with astringent, stimulant,
expectorant, diuretic, diaphoretic, antipyretic, stomachic,
emmenagogue and antiseptic properties. It is reported
to be useful in ulcers, tumours, goitre. It is used
in the preparation of an ointment for sores and is used
with butter in syphilis. The gum resin is sweet, bitter,
astringent, antipyretic, antidysenteric, expectorant,
diaphoretic, diuretic, stomachic, and emmenagogue. It
is useful in fevers, diaphoresis, convulsions, dysentery,
urethrorrhea, orchiopathy, bronchitis, asthma, cough,
stomatitis, syphilitic diseases, chronic laryngitis,
jaundice and arthritis.
Phytochemistry:
The major bioactive constituents of Boswellia serrata
are pentacyclic triterpene acids viz., ?-boswellic acid,
acetyl-?-boswellic acid, 11-keto-?-boswellic acid, acetyl-11-keto-?-boswellic
acid and tetracylic triterpene acids viz. elemolic acid
and elemonic acid. The gum contains sugars viz. D-galactose,
D-arabinose, D-xylose and D-mannose. It also contains
volatile oil and uronic acids.
Pharmacology:
Boswellia serrata a gum resin
has been reported to have analgesic, antiinflammatory,
antiarthritic and antipyretic activity. The other activity
studied are antihyperlipidimic, antiatherosclerotic
and anticancer.
Marker constituents
:Boswellic acid, Acetyl-?-boswellic acid, 11-keto-?-boswellic
acid, Acetyl-11-keto-?-boswellic acid.
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Acetyl-11-keto-?-boswellic
acid
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Main uses: Anti-inflammatory,
Antiarthritic.
Specification:
60% Boswellic Acids
| SL NO |
TESTS |
LIMITS |
PROTOCOL |
| 1. |
Description
|
Cream to yellowish brown powder with
characteristic odour. |
| 2. |
Physico-chemical analysis
|
|
|
| Moisture (%w/w) |
< 5.0 |
As per USP <921> Method II |
| Total ash content (%w/w) |
< 2.0 |
As per USP<561> Vegetable Drugs |
| Acid insoluble Ash (%w/w) |
< 0.5 |
| pH of 5% w/v suspension |
4.5 – 7.0 |
As per USP <791> |
| 3. |
Particle Size |
|
|
| Bulk Density (g/cc) |
0.20 – 0.60 |
As per USP <616> Method –
I |
| Tapped Bulk Density (g/cc) |
0.20 – 0.60 |
| 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 |
< 2 ppm |
| 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 |
|
As per USP <467> |
| As per ICH Guidelines |
|
| Methanol |
< 3000 ppm |
| Hexane |
< 290 ppm |
| 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 |
|
|
Total organic acids as;
Boswellic acids (%w/w) |
>=60.0 |
By Titrimetric |
| Boswellic acid ???????(%w/w) |
12.0 - 32.0 |
By HPLC |
| Acetyl-boswellic acid ???????(%w/w) |
4.0 - 15.0 |
| 11-keto-?-boswellic acid (%w/w) |
3.0 - 10.0 |
| Acetyl-11-keto-?-boswellic acid (%w/w) |
2.0 - 8.0 |
| Elemolic acid (%w/w) |
> 5.0 |
| Elemonic acid (%w/w) |
Specification: 70% Boswellic
Acids
| SL NO |
TESTS |
LIMITS |
PROTOCOL |
| 1. |
Description
|
Cream to yellowish brown powder with
characteristic odour. |
| 2. |
Physico-chemical analysis
|
|
|
| Moisture (%w/w) |
< 5.0 |
As per USP <921> Method II |
| Total ash content (%w/w) |
< 2.0 |
As per USP<561> Vegetable Drugs |
| Acid insoluble Ash (%w/w) |
< 0.5 |
| pH of 5% w/v suspension |
4.5 – 7.0 |
As per USP <791> |
| 3. |
Particle Size |
|
|
| Bulk Density (g/cc) |
0.20 – 0.60 |
As per USP <616> Method –
I |
| Tapped Bulk Density (g/cc) |
0.20 – 0.60 |
| 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 |
< 2 ppm |
| 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 |
|
As per USP <467> |
| As per ICH Guidelines |
|
| Methanol |
< 3000 ppm |
| Hexane |
< 290 ppm |
| 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 |
|
|
Total organic acids as;
Boswellic acids (%w/w) |
>= 70.0 |
By Titrimetric |
| Boswellic acid ???????(%w/w) |
20.0 - 32.0 |
By HPLC |
| Acetyl-boswellic acid ???????(%w/w) |
4.0 - 11.0 |
| 11-keto-?-boswellic acid (%w/w) |
3.0 - 10.0 |
| Acetyl-11-keto-?-boswellic acid (%w/w) |
2.0 - 8.0 |
| Elemolic acid (%w/w) |
> 5.0 |
| Elemonic acid (%w/w) |
Specification: 40% Boswellic
Acids
| SL NO |
TESTS |
LIMITS |
PROTOCOL |
| 1. |
Description
|
Cream to yellowish brown powder with
characteristic odour. |
| 2. |
Physico-chemical analysis
|
|
|
| Moisture (%w/w) |
< 5.0 |
As per USP <921> Method II |
| Total ash content (%w/w) |
< 8.0 |
As per USP<561> Vegetable Drugs |
| Acid insoluble Ash (%w/w) |
< 6.0 |
| 3. |
Particle Size |
|
|
| Bulk Density (g/cc) |
0.20 – 0.60 |
As per USP <616> Method –
I |
| Tapped Bulk Density (g/cc) |
0.20 – 0.60 |
| 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 |
< 2 ppm |
| 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 |
|
As per USP <467> |
| As per ICH Guidelines |
|
| Methanol |
< 3000 ppm |
| 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 |
|
|
Total organic acids as;
Boswellic acids (%w/w) |
>= 40.0 |
By Titrimetric |
Note:
1) Cosmetic grade Boswellia serrata extract which gives
very light colour solution in alcohol is also available.
2) Residual solvent analysis and residual pesticide
analysis are performed only on request.
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