SUGARTAB

(Compressible Sucrose)

DESCRIPTION:
Sugartab 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.
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APPLICATIONS AND USE:

When Sugartab is simply blended with the active component plus a suitable lubricant and compressed, it can 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. 2. 3. 4. Appearance pH Loss on drying Particle size (by Ro-Tap )
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Practically white, crystalline, odorless powder. 3.8 - 7.5 Not more than 2.0% 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

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Sugartab is a registered trademark of JRS Pharma (Rettenmaier) Ro-Tap is a registered trademark of W.S. Tyler, Inc.
TDS.QA0.10041.00000.02 Page 1 0f 2 US Office: Phone 845-878-3414 1-800-431-2457 Fax 845-878-3484 UK Office: Phone +44 1737 222323 Fax +44 1737 222545

Issued March 2003

SUGARTAB
(Compressible Sucrose)

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 reevaluation 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 offered 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. JRS Pharma excipients are sold with the understanding that purchasers will determine the suitability of the excipients for their particular applications or purposes.

Issued March 2003 US Office: Phone 845-878-3414 1-800-431-2457 Fax 845-878-3484 UK Office: Phone +44 1737 222323 Fax +44 1737 222545

TDS.QA0.10041.00000.02 Page 2 0f 2