GRANULAC® 200 Milled Lactose Monohydrate - MEGGLE
GranuLac® 200 is a finely milled lactose monohydrate grade with harmonized pharmacopoeial compliance and controlled chemical, particle-size and microbiological specifications.
Fine particle profile with 45-75% below 32 µm and at least 90% below 100 µm.- Lactose assay is controlled between 98.0% and 102.0%.
- Water content is controlled between 4.5% and 5.5%.
- Complies with USP-NF, Ph. Eur., JP and ChP monographs.
- Produced at an EXCiPACT™-certified GMP and GDP site.
- Not classified as hazardous, although accumulated dust may create an explosion hazard.
- Store at 5-35°C under dry, well-ventilated and odour-free conditions.
AI Summary: Presents the principal composition, moisture, purity and elemental limits.
| Key Specifications | |
|---|---|
| Parameter | Specification |
| Assay: Lactose calculated on the anhydrous basis | 98.0-102.0% |
| Water | 4.5-5.5% |
| Loss on drying | Max. 0.5% |
| Sulfated ash | Max. 0.1% |
| Related substances | Max. 0.5% |
| Heavy metals | Max. 5 µg/g |
| Arsenic (As) | Max. 2 µg/g |
AI Summary: Shows the controlled fine particle-size profile of GranuLac® 200.
| Particle Size Distribution | |
|---|---|
| Parameter | Specification |
| Particle size distribution <32 µm | 45-75% |
| Particle size distribution <100 µm | Min. 90% |
AI Summary: Presents the microbiological acceptance limits.
| Microbial Contamination | |
|---|---|
| Parameter | Specification |
| Total aerobic microbial count (TAMC) | Max. 100 cfu/g |
| Total combined yeasts/moulds count (TYMC) | Max. 10 cfu/g |
| Escherichia coli | Absence/10 g |
| Salmonella spp. | Absence/100 g |
AI Summary: Presents the material identity, appearance and solubility.
GRANULAC® 200
Milled lactose monohydrate supplied as a white or almost white, crystalline, odourless powder. It is freely but slowly soluble in water and practically insoluble in ethanol 96%, chloroform, and ether.
AI Summary: Covers identity, specifications, compliance, safety and storage.
What is GRANULAC® 200?
A finely milled lactose monohydrate grade manufactured by MEGGLE.
Which pharmacopoeias does it comply with?
Ph. Eur., USP-NF, JP, and ChP.
What is its particle-size profile?
At least 90% is below 100 µm, with 45-75% below 32 µm.
Is GRANULAC® 200 classified as hazardous?
No. It is not classified as hazardous under CLP, but airborne dust presents an ST 1 dust-explosion risk.
How should it be stored?
In tightly closed original packaging at 5-35°C under dry, well-ventilated, and odour-free conditions.
Is it dangerous for transport?
No. It is not classified as dangerous under ADR/RID, IMDG, or ICAO/IATA.
AI Summary: Covers hazard status, dust precautions, incompatibilities and storage requirements.
Safety and Storage
- Not classified as hazardous under Regulation (EC) No. 1272/2008.
- No hazard labelling is required.
- Accumulated fine dust may create an explosion hazard.
- Avoid unnecessary dust generation.
- Store between 5°C and 35°C in a dry, well-ventilated place.
- Keep containers tightly closed under odour-free conditions.
- Protect from heat and other energy sources.
- Keep away from oxidizing agents and highly acidic or alkaline materials.
- Carefully close opened containers and keep them upright.
AI Summary: Summarizes environmental precautions, water-hazard classification and transport status.
Environmental and Transport Information
- Not classified as hazardous to the environment.
- Prevent release into drains, waterways and soil.
- Classified as non-hazardous to water in Germany.
- Not classified as dangerous goods under ADR/RID, IMDG or ICAO/IATA.