In the precision-focused pharmaceutical and food manufacturing industries, every excipient choice directly affects product safety, stability, and efficacy. Grace’s SYLOID® AL-1FP silicon dioxide is a rigorously validated critical material. Issued on September 28, 2023, this Certificate of Analysis is more than a quality report—it is definitive proof of the product’s exceptional performance and uncompromising compliance.

SYLOID® AL-1FP strictly adheres to the world’s most rigorous global standards. The certificate confirms full compliance with the latest USP/NF specifications for Silicon Dioxide and JPE requirements for Hydrated Silicon Dioxide. Its elemental impurity control is exceptional: sulfate ≤0.5%, chloride ≤0.1%, and heavy metals (Cd<0.5mg/kg, As<0.5mg/kg, Pb<1mg/kg, Hg<0.1mg/kg) are well below international safety thresholds, fully aligning with ICH Q3D guidelines.

It also meets authoritative food additive standards, including FCC and EU Regulation (EU) No. 231/2012 for E551 (silicon dioxide). This dual compliance makes it a reliable pharmaceutical excipient and safe food additive, enabling seamless cross-industry application.

The certificate’s analytical data highlights SYLOID® AL-1FP’s superior physicochemical properties:

: SiO₂ content reaches 99.4%, exceeding the 99.0% minimum specification for unmatched consistency.

: Average particle size of 7.4 μm, perfectly within the 6.5–8.1 μm range for uniform dispersion and optimal flowability.

: A pH of 5.0 (within 4.0–6.0) provides a gentle, stable environment for sensitive formulations.

: Wet screen residue (>42 μm) <0.01% (meets limit); loss on drying (0.6%) and ignition (6.3%) are strictly controlled to avoid stability issues.

These engineered parameters make SYLOID® AL-1FP an indispensable excipient in pharmaceutical and food manufacturing.

As a low-pore-volume, high-surface-area synthetic amorphous silica, SYLOID® AL-1FP excels at moisture adsorption—controlling trace moisture even at low relative humidity. This protects moisture-sensitive APIs, slows degradation, and extends product shelf life and efficacy.

In pharmaceuticals, it acts as a superior flow aid (enhancing powder processing) and stabilizer (safeguarding sensitive antibiotics). In food production, it serves as an anti-caking agent, preventing clumping and maintaining free-flowing properties in powdered products.

Backed by Grace’s rigorous quality management system, SYLOID® AL-1FP is manufactured in compliance with EXCIPACT-GMP and holds DQS certification (Cert. No. 415602 EXCI). Grace guarantees semi-annual batch testing for ongoing compliance. Clear identifiers—order number, batch number (1000404214), and production date (September 9, 2023)—ensure full traceability.

Amid escalating quality demands, SYLOID® AL-1FP’s unrivaled compliance, precision performance, and reliable functionality make it the trusted choice for manufacturers. It is more than an excipient—it is a critical safeguard for product quality and public health.

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