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ARMOR PHARMA™ lactose monohydrate 350M
- CAS Number
- 10039-26-6
- Chemical Name
- Lactose Monohydrate
ARMOR PHARMA™ lactose monohydrate 350 M is a fine milled powder of α lactose monohydrate. This lactose is produced in ARMOR PHARMA™ dedicated state of the art facility in Loudéac (France), manufactured under EXCIPACT™ GMP standards, it conforms to Ph.Eur, USP NF and JP lactose monohydrate monographs.
Properties
- Physical Form
- Powder
- Solid
- Pharma and Nutraceuticals Functions
- Compression Aid
Product families
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
- Oral
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
- Formulation & Processing Aids
Other characteristics
- Brand
- ARMOR PHARMA
- Functions
- Compression Aid
- Dosage Form
- Tablets
- Certifications & Compliance
EXCiPACT, European Pharmacopeia (Ph. Eur.), GMP, ISO 22000, ISO 9001, Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP)
- Grade
- Pharma Grade
- Markets
- Healthcare & Pharma
- Appearance
- White crystalline powder
- Shelf LIfe
- 36 Months
- Soluble In
- Water
- Flowability
- Poured Density
- 0.52 g/mL
- Tapped Density
- 0.79 g/mL
- Carr's Index
- 34 %
- Hausner Ratio
- 1.52
- Insoluble In
- Ethanol (96%)
- Key Benefits
- Compressibility
- Blending properties
- Storage stability
- Technology
- Pharmaceuticals & Nutraceuticals
- Benefit Claims
- Excellent Stability
- Good Blending Properties
- Good Compressibility
- Low Hygroscopicity
- Certifications
- EXCIPACT certified (GMP)
- ISO 9001 and ISO 22000 certified
- Following IPEC cGMP
- On-site Batch testing & Batch release
- Certified animal Rennet-free raw materials
- Packaging Type
- Bags
- Residual Solvents
No class 1, 2, 3 solvents are used during production. (CPMP/ICH/283/95 + CVMP/VICH/502/99)
- Storage Information
Store in original unopened packaging, in a dry and odor free place.
- Manufacturing Technology
- Dry Granulation
- Wet Granulation
- Certifications and Compliance
- EXCiPACT
- European Pharmacopeia (Ph. Eur.)
- GMP
- ISO 22000
- ISO 9001
- Japan Pharmacopeia (JP)
- National Formulary (NF)
- United States Pharmacopeia (USP)
Technical data
Table 1 of 1
16 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Absorbance (Proteins and Light Absorbing Impurities, [A] 1%, 1 cm at 210 to 220 nm) | max. 0.25 | — | — |
| Absorbance (Proteins and Light Absorbing Impurities, [A] 1%, 1 cm at 270 to 300 nm) | max. 0.07 | — | — |
| Absorbance (Proteins and Light Absorbing Impurities, [A] 10%, 1 cm at 400 nm) | max. 0.04 | — | — |
| Acidity or Alkalinity (at ml 0.1 M NaOH) | max. 0.4 | — | — |
| Escherichia Coli | Negative | in 1g | — |
| Heavy Metals | max. 5 | ppm | USP |
| Loss on Drying | max. 0.5 | % | — |
| Particle Size Distribution (max. 100 µm) | min. 96 | % | Air Jet Sieve |
| Particle Size Distribution (max. 250 µm) | 100 | % | Air Jet Sieve |
| Particle Size Distribution (max. 45 µm) | min. 60 | % | Air Jet Sieve |
| Residue on Ignition / Sulphated Ash | max. 0.1 | % | — |
| Salmonella | Negative | in 10g | — |
