Subject: APPLICATIONS AND ADVANTAGES OF
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Date: Tue, 2 Feb 2010 10:48:59 +0530

BIMAL PHARMA PVT. LTD.
www.bimalpha.com

TYPICAL CERTIFICATE OF ANALYSIS

Name of the product
:   ASPARTAME

SR.
NO.

TEST

STANDARD
SPECIFICATION

RESULT

1

Appearance

White
Crystalline Powder

White
Crystalline

2

Specific
Rotation at 20°C Temp.

+14.5°
to + 16.5°

+15.11°

3

Loss on drying (LOD)

NMT
4.5%

2.84%
to 3.16%

4

Residue
On Ignition

(Sulphated
Ash )

NMT
0.2%

0.01
% to 0.06%

5

Impurity
(DKP)

Diketopiperazine

NMT
1.5%

0.26%
to 0.50%

6

Other
Related Substances

(Other
Impurities )

NMT
2.0%

0.93%
to 1.46%

7

Arsenic

NMT
3 ppm

Less
than 3 ppm

8

Lead

NMT
1 ppm

Less
than 1 ppm

9

pH

4.5
to 6.0

4.66
to 4.98

10

Heavy
Metals

NMT
10 ppm

Less
than 10 ppm

11

Organic
Volatile

Impurities
(OVI)

Should
Comply USP

Complies

12

Transmittance

NLT
95.0%

98.5%
to 99.4%

13

Assay
(On ODB)

98.0%
to 102.0%

98.8%
to 100.2%

14

Total
Aerobic Count

NMT
100 cfu / gm.

Complies

Conclusion: The
quality of our Aspartame meets the standards of  FCC V /USP’31 / BP.