EXCIPRESS™ SD2L
EXCIPRESS™ SD2L is a spray dried lactose typically used for direct compression. It is manufactured under GMP standards and conforms to Ph.Eur, USP NF and JP lactose monohydrate monographs. Spray dried lactose consists of fine primary lactose particles bound in a matrix of amorphous lactose, It combines high compaction properties of fine lactose crystals and amorphous lactose & very good flowability of spherical particles.
Properties
- Physical Form
- Powder
- Solid
- Pharma and Nutraceuticals Functions
- Compression Aid
Product families
Applications
- Oral
Product Families
- Formulation & Processing Aids
Other characteristics
- Brand
- EXCIPRESS
- Functions
- Compression Aid
- Dosage Form
- Capsules, Sachets, Tablets
- Capsules
- Sachets
- Tablets
- Certifications & Compliance
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
- 18 Months
- Soluble In
- Water
- Insoluble In
- Ethanol (96%)
- Key Benefits
Excellent compaction properties; Very good flowability; Very good blending properties (Low dose formulations)
- Technology
- Pharmaceuticals & Nutraceuticals
- Benefit Claims
- Excellent Flowability
- 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
- Direct Compression
- Certifications and Compliance
- 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) | 30 - 65 | % | Air Jet Sieve |
| Particle Size Distribution (max. 250 µm) | min. 95 | % | Air Jet Sieve |
| Particle Size Distribution (max. 45 µm) | max. 15 | % | Air Jet Sieve |
| Residue on Ignition / Sulphated Ash | max. 0.1 | % | — |
| Salmonella | Negative | in 10g | — |
