Determination of chloride in saline nasal sprays per USP methodology

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