PROSOLV HD 90

Silicified Microcrystalline Cellulose (Microcrystalline Cellulose, NF, JP, Ph. Eur., BP and Colloidal Silicon Dioxide, NF, Ph. Eur., BP, Light Anhydrous Silicic Acid, JP)

DESCRIPTION:
ProSolv HD 90 is a silicified high-density microcrystalline cellulose composed of 98% microcrystalline cellulose and 2% colloidal silicon dioxide. Silicification of the microcrystalline cellulose is achieved by a patented process, resulting in an intimate association between the colloidal silicon dioxide and microcrystalline cellulose. The residue on ignition result indicates the percent colloidal silicon dioxide in ProSolv HD 90, and the remainder is microcrystalline cellulose. This particular grade has a median particle size (by sieve analysis) in the region of 90 m.

APPLICATIONS AND USE:

ProSolv HD 90 combines the excellent compactibility of microcrystalline cellulose with superior flow properties. Therefore, ProSolv HD 90 is ideally suited to direct compression formulations where it has advantages in both flow and compactibility.

PRODUCT SPECIFICATIONS:
ProSolv HD 90 complies with the monograph for Microcrystalline Cellulose in the NF, JP, Ph. Eur., and BP except where Colloidal Silicon Dioxide NF is referenced. 1. 2. Appearance Identification White or almost white powder. It consists of freeflowing particles. A. A violet-blue color is obtained B. A stable suspension is obtained C. Degree of polymerization is not more than 350 D. A yellow color results when prepared according to the Colloidal Silicon Dioxide NF monograph E. A greenish blue spot is produced when prepared according to the Colloidal Silicon Dioxide NF monograph 3. 4. 5. pH Conductivity Residue on ignition 5.0 - 7.0 Not more than 75 S 1.8 - 2.2%

Issued April 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

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PROSOLV HD 90
Silicified Microcrystalline Cellulose (Microcrystalline Cellulose, NF, JP, Ph. Eur., BP and Colloidal Silicon Dioxide, NF, Ph. Eur., BP, Light Anhydrous Silicic Acid, JP)

PRODUCT SPECIFICATIONS (continued):

6. 7. 8. 9. Water-soluble substances Ether-soluble substances Heavy metals Organic volatile impurities Not more than 0.24% Not more than 0.05% Not more than 0.001% Meets requirement Not more than 6.0% No blue color is produced Completely dissolves

10. Loss on drying 11. Starch 12. Solubility in ammoniacal coppertetramine solution

MICROBIOLOGICAL SPECIFICATIONS:
1. 2. 3. 4. 5. 6. Total aerobic microbial count Total combined yeasts and molds Staphylococcus aureus Pseudomonas aeruginosa Salmonella species Escherichia coli Not more than 100/g Not more than 20/g Absent in 10 g Absent in 10 g Absent in 10 g Absent in 10 g

Issued April 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.QA0.10046.00000.03 Page 2 of 4

PROSOLV HD 90
Silicified Microcrystalline Cellulose (Microcrystalline Cellulose, NF, JP, Ph. Eur., BP and Colloidal Silicon Dioxide, NF, Ph. Eur., BP, Light Anhydrous Silicic Acid, JP)

ADDITIONAL SPECIFICATIONS:
1. Particle size (by Alpine air jet)

Not more than 8.0% retained on #60 mesh sieve (250 m) 45.0 - 80.0% retained on #200 mesh sieve (75 m) 0.35 - 0.50 g/mL 0.45 - 0.68 g/mL

2. Bulk density 3. Tapped density 4. Particle size (by Malvern )

d10 20 - 70 m d50 90 - 160 m d90 160 - 320 m

Assurance that this product meets the Organic Volatile Impurities (OVI) specifications as listed in USP <467> is based on the knowledge that there is no potential for the specific toxic solvents to be present in the material. The product is not exposed to any OVIs during our manufacturing, handling, shipping, and storage. JRS Pharma warrants that this material, if tested, will comply with the established standards.

PACKAGING:
ProSolv HD 90 is available in 25 kg polyethylene-lined bags; it is also available in 50 kg drums. Other packaging options available by request.

STORAGE RECOMMENDATIONS:
ProSolv HD 90 should be stored in original, unopened, well-closed containers under conditions that do not typically exceed 30C and 70% RH. When stored as recommended, ProSolv HD 90 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, conductivity and water-soluble substances re-evaluation tests are within specification.

ADDITIONAL TECHNICAL INFORMATION:

Chemical Abstract Service (CAS) Registry Number: 9004-34-6, 112945-52-5 ProSolv HD 90 Drug Master File number: 12150

Issued April 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.QA0.10046.00000.03 Page 3 of 4

PROSOLV HD 90
Silicified Microcrystalline Cellulose (Microcrystalline Cellulose, NF, JP, Ph. Eur., BP and Colloidal Silicon Dioxide, NF, Ph. Eur., BP, Light Anhydrous Silicic Acid, JP)

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.

Please be advised that J. Rettenmaier & Shne GmbH & Co. KG (Rettenmaier) is the owner of patents and patent applications that cover ProSolv HD (Prosolv) and the manufacture, use and sale of any product that contains Prosolv. Rettenmaier hereby authorizes the buyer, under Rettenmaiers rights, to use Prosolv to develop and sell a solid dosage form containing any active ingredient other than clodronate, metformin, or acetaminophen (paracetamol), provided that such solid dosage form is not manufactured by adding Prosolv to a drying chamber of a spray drier while the active ingredient is being spray dried therein. If buyer resells Prosolv without combining it with an active ingredient, such Prosolv must be resold in its original packaging with a copy of this paragraph attached.

Prosolv and Prosolv HD are registered trademarks of J. Rettenmaier & Shne GmbH & Co. KG Alpine is a registered trademark of Alpine GmbH Malvern is a registered trademark of Malvern Instruments Inc.

Issued April 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

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