1.

Charge 90% of item 8 in a suitable stainless steel vessel

Use water as a solvent to dissolve other components
2. Dissolve in the following order
a. Hydroxypropyl methyl cellulose–Methocel E4M (1.00 mg/mL)
Solubility: 1 in 2 parts water, easy to dissolve
Acidity/alkalinity pH = 5.0–8.5 for a 1% w/w aqueous solution. Add directly to water,
hydrate after 1-3 hours.
b. azelastine hydrochloride
it is sparingly soluable in water, 35mg/L, be added to water phase soon to totally dissolve.
c. edetic acid disodium dehydrate( 0.5 mg/mL)
Edetic acid is used in pharmaceutical formulations as chelating agents.
Antimicrobial activity: Edetic acid and is frequently used in combination with such
preservative as benzalkonium chloride
d. sodium chloride
isotonic agent. Solubility of NaCl is 1 : 2.8 in water, easy to dissolve
The addition of sodium chloride to aqueous spray-coating solutions containing
hydroxypropyl cellulose or hypromellose suppresses the agglomeration of crystalline
cellulose particles.
Used to modified vicosity.
e. benzalkonium chloride (0.125mg/mL)
preservative, very soluble in water.
f. citric acid
adjust pH, chelating agent, antioxidant
g. sodium monohydrogenphosphate, and mix well.
is used as a buffering agent and as a sequestering agent. Solubility: Very soluble in water
3. Bring to volume with item 8.
4. Pass the solution through a membrane filter of pore size 0.22 microns.
5. The filtrate has a pH value of 6.8 ± 0.3.
6. Fill in plastic bottles that are closed with a conventional spray insert or into plastic or glass
bottles that are closed with a conventional pump sprayer. In the latter case, pumps with nasal
spray inserts are, for example, used that spray approximately 0.14 mL of solution per
actuation. In this manner, 0.14 mg of azelastine hydrochloride is sprayed into the nose per
actuation in the form of the sol