The Global Standard for Fluoroquinolones
Ciprofloxacin Hydrochloride (HCl) remains one of the most widely utilized broad-spectrum antibiotics in the world. From treating urinary tract infections to complex respiratory ailments, its efficacy is undisputed. However, for the pharmaceutical manufacturer, Ciprofloxacin HCl presents a unique set of physical and chemical challenges that can disrupt production if the raw material is not of the highest caliber.
The Solubility and Bioavailability Advantage
The primary reason formulators choose the Hydrochloride salt over Ciprofloxacin Base is solubility. Ciprofloxacin HCl is significantly more soluble in water, which is a prerequisite for rapid absorption in the gastrointestinal tract.
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The Hydrate Factor: Ciprofloxacin HCl typically exists as a monohydrate. Controlling the water of crystallization is critical. If the moisture content fluctuates outside the 4.7%–6.7% range, the crystalline structure can shift, directly impacting the dissolution rate and the stability of your finished tablet.
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Our Process: We utilize a controlled crystallization technique that ensures the monohydrate form is uniform across every batch. This provides a predictable dissolution profile that helps your R&D team hit their "Q" values in dissolution testing every time.
Overcoming Manufacturing Bottlenecks: "Picking" and "Sticking"
One of the most common complaints in Ciprofloxacin production lines is the "stickiness" of the powder. During high-speed tableting, the API tends to adhere to the punch faces, leading to defective tablets and frequent downtime for cleaning.
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Particle Size Optimization: We offer Ciprofloxacin HCl with a tailored particle size distribution (PSD). By ensuring a specific ratio of granules to fines, we improve the flowability of the powder through the hopper and reduce the static charge that causes sticking.
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Tapped Density: Our API is processed to have a consistent bulk and tapped density. This ensures that the die cavity is filled uniformly, which is the only way to maintain tight weight-variation tolerances in a 500,000-tablet run.
Managing the Impurity Profile (The NDMA and Related Substances Era)
Regulatory bodies like the FDA and EMA have increased their scrutiny of "Related Substances" in fluoroquinolones. Specific impurities, such as Fluoroquinolonic Acid or Ethylenediamine analogs, must be kept at absolute minimums.
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Synthesis Purity: Our Ciprofloxacin HCl is synthesized using a high-yield, low-impurity route. We monitor for "Impurity C" and "Impurity E" with high-performance liquid chromatography (HPLC) to ensure they fall well below the USP/BP limits.
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Heavy Metal Control: By using glass-lined reactors and strictly filtered solvents, we ensure that catalysts and heavy metals are virtually non-existent in the final API.
Why B2B Buyers Choose Our Ciprofloxacin HCl
When you source from us, you are not just buying a powder; you are buying a smoother production cycle. We provide:
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Full Regulatory Dossier: Including DMF and stability data for various climate zones (Zone II, IVa, and IVb).
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Batch Consistency: We understand that even a slight change in the "feel" of the powder can require a complete recalibration of your tablet press. Our batches are identical, month after month.
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Custom Packaging: Available in moisture-barrier drums to ensure the API reaches your facility in the exact same state it left ours.
Product link:https://arshinepharma.com/productdetail/Ciprofloxacin-Hcl