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English
Name: Neem |
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Family:
Meliaceae |
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Part
used: Leaves and seeds. |
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Traditional
Uses: |
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Neem
has been extensively used in Ayurveda, Unani
and Homoeopathic medicine and has become a
cynosure of modern medicine. It has been used
traditionally for the treatment of inflammation,
infections, fever, skin diseases and dental
disorders1,2. |
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Phytochemistry:
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About
100 compounds, mostly triterpenoids of protolimonoids,
limonoids, tetranortriterpenoid-γ-hydroxy
butenolides, and pentanortriterpenoids have
been reported from various parts of neem.
Fruits yields azadirachtin, azadirachtol,
azadirachnol. In seeds, azadirachtin and margosene. |
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Pharmacology: |
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Neem has
been reported to possess antibacterial3-6,
antihyperglycaemic7-9, immunomodulatory10,
anti-inflammatory11, antiulcer,
antimalarial, antifungal, antiviral, antioxidant,
antimutagenic and anticarcinogenic properties.
It also possess anti-parasitic, and hepatoprotective
effects1. |
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Indication:
Anti-bacterial and Sugar lowering. |
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References: |
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1. |
Subapriya R and Nagini
S. Medicinal properties of neem leaves: a review,
Curr Med Chem |
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Anticancer
Agents. 2005 Mar; 5(2):149-6. |
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2. |
Sharma P.C et al., Database
on medicinal plants used in Ayurveda, Central
council for Research in |
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Ayurveda
and Siddha, New Delhi, 2000, pp291-292. |
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3. |
Thakurta
P et al, Antibacterial, antisecretory and
antihemorrhagic activity of Azadirachta indica
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used to
treat cholera and diarrhea in India, J Ethnopharmacol.
2007 May 22; 111(3):607-12. |
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4. |
Das BK, et al, Neem (Azadirachta
indica) extract as an antibacterial agent against
fish pathogenic |
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bacteria,
Indian J Exp Biol. 1999 Nov; 37(11):1097-100. |
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5. |
Vanka A et al, The effect
of indigenous Neem Azadirachta indica [correction
of (Adirachta indica)] |
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mouth washes
on Streptococcus mutans and lactobacilli growth,
Indian J Dent Res. 2001 Jul- |
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Sep;12(3):133-44. |
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6. |
Pai MR, et al, Evaluation
of antiplaque activity of Azadirachta indica
leaf extract gel--a 6-week |
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clinical
study,J Ethnopharmacol. 2004 Jan; 90(1):99-103. |
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7. |
Halim EM. Lowering of
blood sugar by water extract of Azadirachta
indica and Abroma augusta in |
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diabetes rats, Indian
J Exp Biol. 2003 Jun; 41(6):636-40. |
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8. |
Gholap S and Kar A, Hypoglycaemic
effects of some plant extracts are possibly
mediated through |
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inhibition
in corticosteroid concentration, Pharmazie.
2004 Nov; 59(11):876-8. |
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9. |
Chattopadhyay RR, A comparative
evaluation of some blood sugar lowering agents
of plant origin, J |
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Ethnopharmacol.
1999 Nov 30; 67(3):367-72.v |
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10. |
Upadhyay SN et al, Immunomodulatory
effects of neem (Azadirachta indica) oil, Int
J |
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Immunopharmacol.
1992 Oct; 14(7):1187-93. |
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11. |
Chattopadhyay RR, Possible
biochemical mode of anti-inflammatory action
of Azadirachta indica A. |
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Juss. in
rats, Indian J Exp Biol. 1998 Apr; 36(4):418-20. |
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DOC
NO. |
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NR/QCD/SPC/115 |
| ISSUE
DATE |
: |
02-04-2007 |
| REVISION
NO. |
: |
00 |
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| ANALYTICAL
SPECIFICATION |
NUMBER
OF PAGES |
: |
01 |
| TITLE
: AZADIRACHTA INDICA EXTRACT (³ 2.5%
TOTAL BITTERS) |
| Plant
part |
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Leaves |
| Fresh/Dry |
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Dry |
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Sl. No. |
Tests |
Limits |
Protocol |
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1.
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Description |
Light brown to Brown
hygroscopic powder with characteristic
odour |
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2.
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Identification |
To
pass the test |
By
TLC |
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3.
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Physico-chemical analysis |
<
10.0 |
As
per USP <921> Method III |
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Loss on drying (%w/w) |
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Acid insoluble Ash (%w/w) |
<
7.5 |
As per USP <561> |
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4.
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Particle
Size |
0.20
- 0.80 |
As
per USP <616> Method - I |
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Bulk Density (g/cc) |
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Tapped bulk density (g/cc) |
0.25
- 0.90 |
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Material passing
through 30# BS/35 ASTM (%w/w) |
>
90.0 |
As
per USP <786>
Particle
Size distribution. |
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5.
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Heavy metal analysis |
<
10 ppm |
AAS
/ ICP -ES |
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Lead |
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Arsenic |
<
2 ppm |
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Cadmium |
<
1 ppm |
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Mercury |
<
0.1 ppm |
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6.
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Microbiological analysis |
<
104 cfu g-1 |
As per WHO/PHARMA/92.559/Rev.1 Pg.49-52 / As per USP <61> & <62> |
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As per
FIP Guidelines |
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Total Viable Aerobic Count |
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Total Enterobacteriaceae |
<
102 org g-1 |
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Total Fungal Count |
<
102
fs g-1 |
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7.
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Test for Specific Pathogen |
Absent |
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As per FIP Guidelines
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E.coli
(1g) |
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Salmonella
Sp. (10g) |
Absent |
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S.aureus
(1g) |
Absent |
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8.
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Mycotoxin analysis |
<
5 ppb |
As
per USP Test for Aflatoxins |
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Aflatoxins (B1 + B2
+ G1 + G2) |
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Residual solvent analysis |
<
3000 |
As
per USP |
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As per
ICH Guidelines |
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| Methanol (ppm) |
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| 10.
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Pesticide residue analysis |
To
comply with USP |
As
per AOAC/USP |
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As per
USP & BP Limits |
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| Organochlorine Pesticides |
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| Organophosphorus Pesticides |
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| Synthetic pyrethroids |
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| 11.
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Phytochemical analysis |
³
2.5 |
By
Gravimetry |
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| Total
Bitters (%w/w). |
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