HEWETEN® 101 / 102 Microcrystalline Cellulose - JRS PHARMA
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HEWETEN® 101 and HEWETEN® 102 are Microcrystalline Cellulose grades for pharmaceutical and food applications, with references to Ph. Eur., NF, JP, E460(i), and FCC.
Microcrystalline Cellulose grades with Ph. Eur., NF, JP, E460(i), and FCC references.- HEWETEN® 101 and 102 share the same core chemical and microbiological limits.
- Grade difference is mainly reflected in bulk density and particle size distribution.
- HEWETEN® 101 and 102 differ mainly by particle size and bulk density profile.
- Manufactured under excipient GMP principles according to IPEC and USP <1078>.
- Recommended re-evaluation period is 5 years from manufacturing date.
Shows the material identity and grades covered in this listing.
Composition and Identity
HEWETEN® 101 and HEWETEN® 102 are Microcrystalline Cellulose grades within the HEWETEN® product range.
Technical specifications table showing chemical, physical, and microbiological specifications for HEWETEN® 102.
| Technical Specifications | ||
|---|---|---|
| Parameter | Acceptance criteria | Reference |
| Identification A, (2) | IR scan conforms | Ph. Eur., NF, JP |
| Identification B, (1) | Violet-blue color | Ph. Eur., NF, JP |
| Identification C, (3) | Degree of polymerization max. 350 | Ph. Eur., NF, JP |
| Conductivity | Max. 75 µS/ cm | Ph. Eur., NF, JP |
| Ether-soluble substances | Max. 0.05 % | Ph. Eur., NF, JP |
| Heavy metals | Max. 10 ppm | JRS Method |
| Loss on drying | Max. 7.0 % | Ph. Eur., USP, JP |
| pH | 5.0 – 7.0 | Ph. Eur., USP, JP |
| Solubility | Dissolves completely | Ph. Eur. |
| Sulphated ash / residue on ignition | Max. 0.05 % | Ph. Eur., USP, JP |
| Water-soluble substances | Max. 0.24 % | Ph. Eur., NF, JP |
| TAMC (Total Aerobic Microbial Count) | 10² cfu/ g | Ph. Eur., USP, JP |
| TYMC (Total Yeast and Mold Count) | 20 cfu/ g | Ph. Eur., USP, JP |
| Escherichia coli | Absent in 1 g | Ph. Eur., USP, JP |
| Pseudomonas aeruginosa | Absent in 1 g | Ph. Eur., USP, JP |
| Salmonella species | Absent in 10 g | Ph. Eur., USP, JP |
| Staphylococcus aureus | Absent in 1 g | Ph. Eur., USP, JP |
| Bulk density | 0.27 – 0.33 g/ mL | NF, JP |
| Particle Size (retained on air jet sieve) | ||
| > 250 µm (60 mesh) | Max. 8 % | JRS Method |
| > 75 µm (200 mesh) | Min. 45 % | JRS Method |
| > 32 µm (450 mesh) | Min. 70 % | JRS Method |
| Particle Size (laser diffraction) | ||
| d10 | 20 – 55 µm | JRS Method |
| d50 | 90 – 160 µm | JRS Method |
| d90 | 190 – 310 µm | JRS Method |
Technical specifications table showing physical, chemical, microbiological, and particle size criteria for HEWETEN® 101.
| Technical Specifications | ||
|---|---|---|
| Specification | Acceptance Criteria | Test Method |
| Identification A, (2) | IR scan conforms | Ph. Eur., NF, JP |
| Identification B, (1) | Violet-blue color | Ph. Eur., NF, JP |
| Identification C, (3) | Degree of polymerization max. 350 | Ph. Eur., NF, JP |
| Conductivity | Max. 75 µS/ cm | Ph. Eur., NF, JP |
| Ether-soluble substances | Max. 0.05 % | Ph. Eur., NF, JP |
| Heavy metals | Max. 10 ppm | JRS Method |
| Loss on drying | Max. 7.0 % | Ph. Eur., USP, JP |
| pH | 5.0 – 7.0 | Ph. Eur., USP, JP |
| Solubility | Dissolves completely | Ph. Eur. |
| Sulphated ash / residue on ignition | Max. 0.05 % | Ph. Eur., USP, JP |
| Water-soluble substances | Max. 0.24 % | Ph. Eur., NF, JP |
| TAMC (Total Aerobic Microbial Count) | 10² cfu/ g | Ph. Eur., USP, JP |
| TYMC (Total Yeast and Mold Count) | 20 cfu/ g | Ph. Eur., USP, JP |
| Escherichia coli | Absent in 1 g | Ph. Eur., USP, JP |
| Pseudomonas aeruginosa | Absent in 1 g | Ph. Eur., USP, JP |
| Salmonella species | Absent in 10 g | Ph. Eur., USP, JP |
| Staphylococcus aureus | Absent in 1 g | Ph. Eur., USP, JP |
| Bulk density | 0.25 - 0.31 g/ mL | NF, JP |
| Particle Size (retained on air jet sieve) | ||
| > 250 µm (60 mesh) | Max. 1 % | JRS Method |
| > 75 µm (200 mesh) | Max. 30 % | JRS Method |
| > 32 µm (450 mesh) | Min. 50 % | JRS Method |
| Particle Size (laser diffraction) | ||
| d10 | 10 - 35 µm | JRS Method |
| d50 | 40 - 85 µm | JRS Method |
| d90 | 90 - 180 µm | JRS Method |
Covers product identity, grade differences, re-evaluation period, CLP classification, and residual solvent status.
What is the main difference between HEWETEN® 101 and HEWETEN® 102?
The main differences are bulk density and particle size distribution.
What is the re-evaluation period?
The TDS lists a re-evaluation date of 5 years from manufacturing date.
What compendial standards are referenced?
HEWETEN® is referenced as Microcrystalline Cellulose Ph. Eur., NF, JP, E460(i), and FCC.
Does the product contain residual solvents?
The raw materials, manufacturing process, and product do not contain solvents listed in Ph. Eur. <5.4> or USP <467>.
How should the material be stored?
Protect against humidity and do not expose to temperatures above 50°C / 122°F.
Shows the key storage and handling conditions for HEWETEN® Microcrystalline Cellulose.
Safety and Storage
- Product is intended for professional use.
- Product is not classified as hazardous under CLP.
- Protect against humidity.
- Do not expose to temperatures above 50°C / 122°F.
- Avoid generation and inhalation of dust.