Tablettose® 100 Low Nitrite
MEGGLEs Low Nitrite grades – simplifying nitrosamine compliance with specified nitrite limit!
Due to the nitrosamine issue, the risk assessment and review of nitrite content in excipients have become essential. Pharmaceutical manufacturers must take appropriate measures, especially for critical products.
Agglomerated lactose, such as MEGGLE’s Tablettose®, offers significant advantages in pharmaceutical applications. Produced through a continuous spray agglomeration process, it combines the excellent flowability of coarse lactose with the good compactibility of fine milled lactose, making it ideal for direct compression tableting.
Tablettose® 100 Low Nitrite is produced from a starting material with finer particle size distribution, resulting in higher compactibility compared to other Tablettose® grades. Its increased binding capacity allows for a higher dilution potential, making it ideal for formulations requiring enhanced compactibility and uniformity.
Nitrite testing is not a pharmacopoeia requirement, however MEGGLE has developed a method using ion chromatography to accurately quantify nitrite, whereby the limit of quantification (LOQ) is 0.03 ppm. Values below this limit will be reported as < 0.03 ppm. Through additional validation, we have demonstrated that we can safely specify a limit of ≤ 0.10 ppm.
MEGGLE measures the nitrite parameter on each lot. The nitrite value is part of the Product Specification and the corresponding Certificate of Analysis (CoA) for all MEGGLE Low Nitrite grades. This does not only simplify the risk assessment, but also demonstrates compliance with the defined nitrite limits for critical products.
Benefits
- Low hygroscopicity
- Excellent stability
- Superior blending characteristics
- Good flowability
- Good tabletability
- Low moisture content
- Fast disintegration times
- Simplified Compliance: Streamlines nitrosamine compliance with a specified nitrite limit.
- Accurate Measurement: Uses ion chromatography for precise nitrite quantification, with a LOQ of 0.03 ppm.
- Validated Safety: Ensures a safe nitrite limit of ≤ 0.10 ppm, meeting industry targets.
- Consistent Quality: Includes nitrite values in every lot’s Product Specification and CoA.
Areas of Application
- Direct compression
- Capsule and sachet filling
- Continuous applications
- Effervescent tablets
- Artificial sweetener tablets
- Manufacturers seeking to minimize risks associated with nitrosamine formation in their production processes.
- All applications of standard products
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- Direct compression
- Continuous processing
- Agglomerated Lactose
- Oral Solid Dose
- Effervescent tablet
- Artificial sweetner tablet
- Orally disintegrating tablet (ODT)
- Placebo tablet
- Low dose DC formulation
- Capsule
- Sachet
- Tablet
25kg – Paper bag with PE-EVOH-PE inliner
24 months
Wasserburg am Inn, Germany
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Typical particle size distribution
Typical Product Data
- x10: 32 µm, x50: 121 µm, x90: 293 µm
- Span [(x90-x10)/x50]: 2.16
- Density bulk: 0.584 g/ml
- Density tapped: 0.714 g/ml
- Hausner Ratio: 1.22
- Carr’s Index: 18 %
Specified Product Data
Particle size distribution
Sieve Method: Mechanical sieve shaker
- <63 µm: NMT 25%
- <75 µm: 10-30%
- <150 µm: 40-70%
- <250 µm: 60-90%
- <355 µm: NLT 90%
- <500 µm: 100%
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