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SUGARTAB

(Compressible Sucrose)

Issued March 2003 TDS.QA0.10041.00000.02

Page 1 0f 2

US Office: Phone 845-878-3414 1-800-431-2457 Fax 845-878-3484UK Office: Phone +44 1737 222323 Fax +44 1737 222545

DESCRIPTION:

Sugartab1

is a white, free-flowing, sugar product with an agglomerated median particle size of ca. 300

m (by sieve analysis) comprising approximately 90 - 93% sucrose with the balance being invert sugar.

APPLICATIONS AND USE:

When Sugartab

issimply blended with the active component plus a suitable lubricant and compressed,

itcan be directly compressed to produce hard, nonfriable, pharmaceutically elegant tablets which offer

the palatability and mouth-feel characteristics desirable in chewable and other water soluble tablets.

Sugartab

is an excellent vehicle for direct compression. It offers good flow characteristics, excellent

compressibility and numerous additional beneficial properties including flavor-masking, relatively low

hygroscopicity, chemical stability, non-cloying sweetness, a wide range of compatibilities, smooth

disintegration and pleasant aftertaste.

Sugartab

has been used extensively in vitamin formulations where the coarse mesh size makes it an

excellent carrier for material which may have certain inherent compression problems.

PRODUCT SPECIFICATIONS:

1. Appearance Practically white, crystalline, odorless powder.

2. pH 3.8 - 7.5

3. Loss on drying Not more than 2.0%

4. Particle size (by Ro-Tap2

) Not more than 50.0% is retained on a #20 mesh sieve

(850 m)

Not more than 30.0% passes through a #80 mesh sieve

(180 m)

5. Tapped density 0.6 - 0.8 g/mL

MICROBIOLOGICAL SPECIFICATIONS:

1. Total aerobic microbial count Not more than 1000/g

1

Sugartab is a registered trademark of JRS Pharma (Rettenmaier)2

Ro-Tap

is a registered trademark of W.S. Tyler, Inc.

7/28/2019 sugartab-rev.-02.pdf

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SUGARTAB

(Compressible Sucrose)

Issued March 2003 TDS.QA0.10041.00000.02

Page 2 0f 2

US Office: Phone 845-878-3414 1-800-431-2457 Fax 845-878-3484UK Office: Phone +44 1737 222323 Fax +44 1737 222545

PACKAGING:

Sugartab

is available in 100-kg drums.

STORAGE RECOMMENDATIONS:

Sugartab

should be stored in original, unopened, well-closed containers under conditions that do not

typically exceed 30C and 70% RH. When stored as recommended, Sugartab

has a recommended re-

evaluation period of three (3) years from the date of manufacture. An additional year can be added if the

Loss on Drying tests within specification.

ADDITIONAL TECHNICAL INFORMATION:

Nutritional information: 100% carbohydrate with a caloric content of 4 kcal/g.

Very soluble in water, slightly soluble in alcohol.

WARRANTY:

The information contained in this document is believed to be accurate at the time of issuance and is of-

fered in good faith, with no assumption of liability on the part of JRS Pharma, as a guide to the use and

testing of the material, but in no way does this information constitute a performance warranty. JRSPharma excipients are sold with the understanding that purchasers will determine the suitability of the

excipients for their particular applications or purposes.