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M/S. BIMAL PHARMA PVT. LTD .

MUMBAI (INDIA)

FINESHED PRODUCT

INFORMATIONS

QUALITY CONTROL AND ASSURANCE

PRODUCT : SUCRALOSE

MSDS no. BPPL 120

(Available
on Request)

SPECIFICATION NO. FP- 120

(Enclosed)

1.     NOMENCLATURE                 :      4,
1’,6’ – Tri Chloro -4, 1’, 6’ – Tri Deoxy-

Penta Galactosucrose.

:      Tri Chloro
Galactosucrose

(4,
1’,6’ – Tri Chloro Galactosucrose).

:      1,6
Di Chloro – 1,6 – Dideoxy – beta – D –

Fructofuranosyl
– 4, Chloro – 4 – Deoxy –

alpha
– D – Galacto Pyranoside)

2.      CAS  NO.                            :      56038-13-2

3.      EMPIRICAL
FORMULA      :      C12H19Cl3O8

4.      MOL. WT.                            :      397.64

5.      STRUCTURAL
FORMULA   :

6.      DESCRIPTION
:      White to Off -White crystalline powder.

:      It
is odorless.

:      Strong
sweet taste.

:      Freely
soluble in Water, Methanol and

Ethanol,
and is slightly soluble in Ethyl

Acetate.

7.      APPLICATIONS                 :      It
is 600 times sweeter than Sugar.

:      Used
in preparation of Carbonated soft

Drinks and   Beverages.

:      Used
in Baked Foods and Dairy Products.

:      Confectionery.

:      Canned
Fruits and Vegetables.

:      Ice
creams ; Jams ; Dairy Products ,

Chewing Gum, Pickles and Sauces etc.

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2 of 2

M/S. BIMAL PHARMA PVT. LTD .

MUMBAI
(INDIA)

FINESHED PRODUCT

PHARMACOPOEIAL SPECIFICATIONS

QUALITY CONTROL AND ASSURANCE

PRODUCT : SUCRALOSE USP’32 / FCC
VI

MSDS no. BPPL 120

(Available on Request)

SPECIFICATION NO. FP- 120

1.      DESCRIPTION
:      A White to Off-White
Crystalline Powder .

2.      SOLUBILITY                      :      Freely soluble in Water, Methanol
and

Ethanol,
and is slightly soluble in Ethyl

Acetate.

3.      IDENTIFICATION              :      A) By IR

B)
By HPLC

C)
By TLC

4.      CLARITY
AND COLOR       :      1.0
gm,. Solution in 10 ml. water is Clear.

OF SOLUTION

(Appearance of Solution)

5.      SPECIFIC
ROTATION        :      Bet. + 84.0° to 87.5° on Anhy.
Basis.

(At 20°C of 1% Sol. in water)

6.      WATER
CONTENT               :      Max. 2.0%

(BY
KF)

7.      pH                                       :
3.0 to 6.0

(2.0 gm., in 20 ml. Water.)

8.      HEAVY METALS                  :      NMT 0.001%   (10 ppm)

9.      ARSENIC  (as As2O3)        :      NMT 0.0004%  (4 ppm)

10.    RESIDUE ON IGNITION     :      Max. 0.7%

(Sulphated Ash)

11.    LIMIT OF
HYDROLYSIS    :      Passes the Test  as per USP
and FCC .

PRODUCTS

12.    LIMIT OF
METHANOL        :      Max. 0.1% (1000 ppm)

13.    LIMIT OF LEAD
:      Max. 0.0001% (1 ppm)

14.    RELATED
SUBSTANCES     :      Passes the Test as per USP and FCC.

(NMT 0.5% )

15.    ASSAY
:      Bet.
98.0 % to  102.0%

(Calculated
on Anhy. Basis)

16.    PACKING                            :      10 Kgs. / 20 Kgs. Fibre drums with double

PE liners.

:      1 Kg. packing on
special request, in original

intact packing.

17.    STORAGE                           :      Preserve in a Cool and Dry place .