AN #: 01_004_11_003 Application Note Market: Laboratory Subcategory: Pharmaceuticals www.hannainst.com Product: HI902, HI4115 Measuring Chloride Content of Saline Nasal Sprays Description Pharmacopeias (USP and EP) recommend data collection. The administrative options on Saline nasal sprays are readily available over-the- titration as an effective way to determine the the HI902 allow an administrator to lock the chloride content of both types of nasal spray. titrator with a password. When a titrator is In a chloride titration, silver nitrate is added to locked, users cannot delete or alter any method precipitate the chloride in the sample. Once all parameters or reports. This prevents tampering of the chloride is precipitated, the depletion of with the analysis or associated data. Overall, chloride or excess of silver can be detected with the customer was happy with the accuracy and a chemical or potentiometric indicator. flexibility of the HI902 which allowed them to counter at most local drugstores and offer users relief from irritated nasal passages. The nasal spray industry is a multi-million dollar industry, with saline sprays accounting for a signification portion of sales. Basic saline nasal sprays consist of water and sodium chloride. However, most commercial saline sprays also incorporate continue manufacturing high quality products for millions of clients worldwide. additives such as disodium phosphate and Application benzalkonium chloride to stabilize and preserve A the product. Hanna Instruments interested in testing the Saline sprays are most commonly found in two forms: isotonic and hypertonic. The concentration of sodium chloride in the product determines its designation. Isotonic saline sprays contain chloride in concentrations similar to our own bodies (~0.9%). The use of isotonic nasal sprays is generally a non-irritating way to flush out debris and introduce moisture into nasal passages. Hypertonic nasal sprays contain pharmaceutical manufacturer contacted chloride concentration of various saline spray products in accordance to the USP method. Their products contain a separate sodium chloride packet that the user mixes with a solution prior to use. The manufacturer wanted to ensure that the premeasured sodium chloride packet contained the correct amount of salt to meet the specified concentration of their isotonic and hypertonic nasal sprays. They already had a full scale laboratory and wanted a traceable, chloride concentrations higher than that of our accurate solution for testing their products. own bodies (~3%). Hypertonic saline sprays are Hanna Instruments suggested the HI902 typically used as decongestants. Unlike isotonic Automatic Potentiometric Titrator with the sprays, hypertonic sprays draw moisture out of HI4115 Silver/Sulfide electrode. nasal passages and alleviate congestion. The customer appreciated having a high level The chloride concentration in each product of control over the method parameters and the type must be precise to ensure accurate ability to enable administrative options. Because labeling and to maintain consistency between the customer had to report their test data to products. The United States and European the FDA, they had strict requirements for their
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