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MEGGLE_TroubleshootingGuide Whitepaper

Whitepaper: Granulation & Tablet Compression – Trouble Shooting Guide

TROUBLE SHOOTING GUIDE | Granulation & Tablet Compression Abstract: This troubleshooting guide provides a structured approach for resolving common issues encountered in pharmaceuticalgranulation and tablet compression. It is intended for R&D, MS&T, and production teams across product development, scale-up, and commercial manufacturing. The guide outlines critical process parameters (CPPs) and critical quality attributes (CQAs) for...

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Whitepaper: Focus on Excipients and Nitrite Control

Nitrosamine Risk Mitigation in Pharmaceuticals | Focus on Excipients and Nitrite Control Abstract: The detection of nitrosamine impurities in pharmaceutical products has raised significant regulatory and public health concerns already since 2018. However, reducing potential nitrosamine formation in formulations containing vulnerable amines remains a critical topic. This white paper discusses risk assessment strategies, regulatory expectations,...

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Whitepaper: LACTOSE AS PROTECTIVE ADDITIVE

LACTOSE AS PROTECTIVE ADDITIVE FOR BIOCONTROL USE | Lactose a protective additive for modern agriculture. Sustainable agriculture requires high-performance formulation solutions. As regulatory pressure increases and microplastic-free agricultural formulations gain importance, manufacturers of biological crop protection products are looking for natural, effective and scalable alternatives. This whitepaper explores how lactose as a protective additive in...

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Whitepaper: Homogeneity in Low-Dose Formulations

Synergy of Excipient Selection and Mixing | Homogeneity in Low-Dose Formulations | Abstract: Achieving blend uniformity (BU) in low-dose formulations for direct compression (DC) is challenging. This study used Erythrosine as the model active pharmaceutical ingredient (API) to create blends with 3 % and 1 % API. Two blending methods were tested: Active Blends (single-step...

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